[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05675865":3,"trial-entities:NCT05675865":238,"trial-summary:NCT05675865":242},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":51,"sex":77,"minimum_age":78,"maximum_age":79,"healthy_volunteers":80,"eligibility_criteria":81,"std_ages":114,"locations":117,"central_contacts":230,"overall_officials":231,"references":232,"see_also_links":237},"NCT05675865","CS-300","Cryoablation for Monomorphic Ventricular Tachycardia","Cryoablation for Monomorphic Ventricular Tachycardia IDE Study: EFS and Pivotal","ACTIVE_NOT_RECRUITING","2027-03-30","2026-08","2026-08-07","2023-09-11","Adagio Medical","INDUSTRY",true,"The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio VT Cryoablation System in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT)","A prospective, single-arm, multi-center, open label, pre-market, clinical study designed to provide safety and efficacy data regarding the use of the Adagio System in the treatment of scar-mediated SMVT in ischemic and non-ischemic patients.\n\nStudy subjects will include patients who experience recurrent SMVT and are scheduled for an endocardial VT ablation.\n\nStudy subjects must have an Implantable Cardioverter Defibrillator (ICD) prior to the cryoablation procedure.\n\nThis IDE study includes two phases, an early feasibility (EFS) phase to support initial device safety and effectiveness, and a Pivotal Study phase to collect safety and effectiveness data for a future PMA marketing application.",[19],"Sustained VT",[21,22,23],"cryoablation","monomorphic VT","sustained monomorphic VT","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},206,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","cryoablation procedure","ablation procedure for VT using the investigational device",[37],"VT Cryoablation",[39,43,47],{"measure":40,"description":41,"timeFrame":42},"Primary Safety Endpoint for EFS and Pivotal phases is freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the cryoablation procedure.","Events will be adjudicated by an independent Clinical Events Committee (CEC). MAEs include any of the following:\n\n* Death\n* Acute myocardial infarction\n* Cardiac perforation\u002Fpericardial tamponade\n* Cerebral infarct or systemic embolism\n* Major bleeding requiring transfusion\n* Acute Mitral, Tricuspid or Aortic valve damage resulting in moderate or severe regurgitation\n* Access site complications requiring medical or surgical intervention\n* Pericarditis\n* Heart block requiring a permanent pacemaker\n* Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent Clinical Events Committee (CEC) to be probably or definitely related to the Adagio System.","7 days following the ablation procedure",{"measure":44,"description":45,"timeFrame":46},"Primary Procedural Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with non-inducible VT or no further ablation targets meeting the criteria for ablation at the end of the cryoablation procedure.","Documentation of non-inducibility of any VT targeted for ablation at the end of procedure.","During Procedure",{"measure":48,"description":49,"timeFrame":50},"Primary Efficacy Endpoint for Pivotal Phase","Defined as freedom from recurrent sustained MMVT in the absence of a new AAD or increase in dose of a pre-ablation AAD for VT management at 6 months following the ablation procedure, where sustained MMVT is defined as continuous MMVT for \\> 30 seconds (programmed monitoring zone only), or MMVT requiring appropriate ICD intervention regardless of duration. All ICD interrogation reports will be adjudicated by an independent VT Event Committee (VTEC) to support the primary efficacy endpoint.","6 months after the procedure",[52,56,60,63,66,70,73],{"measure":53,"description":54,"timeFrame":55},"Secondary Safety Endpoint - Analysis of the proportion of subjects with freedom from definite or probable device or procedure related MAEs that occur within 30 days (EFS) or SAEs within 12 months (pivotal) following the cryoablation procedure.","Events will be adjudicated by an independent Clinical Events Committee (CEC).","1 month post cryoablation procedure",{"measure":57,"description":58,"timeFrame":59},"Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from inducible MMVT \u003C30s","Freedom from inducible MMVT with a cycle length similar to (within 30 ms) or slower than the targeted VT and lasting longer than 30 seconds at the end of the ablation procedure.","6-month post cryoablation procedure",{"measure":61,"description":62,"timeFrame":59},"Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from VT > 30 seconds","Freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 6 months (EFS) or 12 months (pivotal).",{"measure":64,"description":65,"timeFrame":59},"Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from VT > 30 seconds without AAD","Freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 6 months in the absence of new AADs or increase in dose of pre-ablation AADs. Drug changes related specifically to management of atrial arrhythmias will not be included in the analysis of this endpoint (EFS",{"measure":67,"description":68,"timeFrame":69},"Health Outcomes for EFS and Pivotal phases are defined as all-cause mortality at 12 months","All-cause mortality at 12 months","12-months post cryoablation procedure",{"measure":71,"description":72,"timeFrame":69},"Health Outcomes for EFS and Pivotal phases are defined as cardiac mortality at 12 months","Cardiac mortality at 12 months",{"measure":74,"description":75,"timeFrame":76},"Health Outcomes for EFS and Pivotal phases are defined as quality-of-life improvement as measured by reduction of VT burden at 6 and 12 months compared to baseline.","Reduction in the number of ICD shocks and number of VT related hospitalizations","6 and 12-months post cryoablation procedure","ALL","18 Years",null,false,{"inclusion":82,"exclusion":94,"raw_text":113},[83,84,85,86,87,88,89,90,91,92,93],"IC 1 Male or female ≥ 18 years","IC 2 Patients with a clinical indication for catheter ablation due to ischemic and\u002For non-ischemic heart disease and recurrent symptomatic sustained scar-mediated monomorphic Ventricular Tachycardia.","IC 3 Any of the following:","Ischemic cardiomyopapthy (ICM) patients with prior history of myocardial infarction with Q waves, focal wall motion abnormality on imaging, fixed perfusion defect correlating with coronary stenosis or prior coronary intervention, 20% ≤ LVEF \\\u003C 50%.","non-ischemic cardiomyopathy (NICM) patients with scar in a territory without coronary stenosis as evidenced by CMR imaging within the prior 90 days or intra-procedurally using EAM and PES prior to investigational device use, 20% ≤ LVEF \\\u003C 50%","Arrhythmogenic right ventricular cardiomyopathy (ARVC)","IC 4 Has received a market-released ICD prior to enrollment","IC 5 Patient has had at least 1 documented spontaneous episode of SMVT within the previous 6 months","IC 6 Refractory to, or intolerant of, at least one Class III AAD. (Refractory or intolerant defined as AAD failure due to recurrent VT, not tolerated\u002F desired due to side effects)","IC 7 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study","IC 8 Willingness and ability to give an informed consent",[95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112],"EC 1 Intracardiac thrombus by TTE or TEE within 48 hours prior to the procedure","EC 2 Presence of isolated epicardial scar(s) requiring epicardial ablation identified by either preoperative CMR imaging within 90 days of procedure or intra-procedurally using EAM and PES prior to investigational device use","EC 3 VTs due to any of the following causes:","EC 4 NICM patients only, if any of the following apply:","EC 5 Any VT ablation within 4 weeks prior to enrollment","EC 6 More than one prior (\\>4 weeks) VT ablation or prior surgical treatment for VT within the past 2 years","EC 7 Cardiogenic shock, unless it is due to incessant monomorphic VT","EC 8 Any other cardiovascular conditions as described below:","EC 9 Acute illness or active systemic infection","EC 10 Any previous history of cryoglobulinemia","EC 11 History of blood clotting or bleeding disease","EC 12 Peripheral vascular disease that precludes LV access","EC 13 Contraindication to heparin","EC 14 Allergy to radiographic contrast dye that cannot be medically managed prior to the ablation procedure","EC 15 Any prior history of documented cerebral vascular accident (CVA), TIA or systemic embolism (excluding a post-operative Deep Vein Thrombosis, DVT), within 6 months prior to the ablation procedure.","EC 16 Pregnant, or anticipated pregnancy during study follow-up","EC 17 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study","EC 18 Any other condition (e.g., ARVC with extensive free wall scarring) that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, candidate for heart transplantation, patient with ventricular assist device, or terminal illness with a life expectancy less than 12 months)","Inclusion Criteria (IC):\n\n* IC 1 Male or female ≥ 18 years\n* IC 2 Patients with a clinical indication for catheter ablation due to ischemic and\u002For non-ischemic heart disease and recurrent symptomatic sustained scar-mediated monomorphic Ventricular Tachycardia.\n* IC 3 Any of the following:\n\n  * Ischemic cardiomyopapthy (ICM) patients with prior history of myocardial infarction with Q waves, focal wall motion abnormality on imaging, fixed perfusion defect correlating with coronary stenosis or prior coronary intervention, 20% ≤ LVEF \\\u003C 50%.\n  * non-ischemic cardiomyopathy (NICM) patients with scar in a territory without coronary stenosis as evidenced by CMR imaging within the prior 90 days or intra-procedurally using EAM and PES prior to investigational device use, 20% ≤ LVEF \\\u003C 50%\n  * Arrhythmogenic right ventricular cardiomyopathy (ARVC)\n* IC 4 Has received a market-released ICD prior to enrollment\n* IC 5 Patient has had at least 1 documented spontaneous episode of SMVT within the previous 6 months\n* IC 6 Refractory to, or intolerant of, at least one Class III AAD. (Refractory or intolerant defined as AAD failure due to recurrent VT, not tolerated\u002F desired due to side effects)\n* IC 7 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study\n* IC 8 Willingness and ability to give an informed consent\n\nExclusion Criteria (EC):\n\n* EC 1 Intracardiac thrombus by TTE or TEE within 48 hours prior to the procedure\n* EC 2 Presence of isolated epicardial scar(s) requiring epicardial ablation identified by either preoperative CMR imaging within 90 days of procedure or intra-procedurally using EAM and PES prior to investigational device use\n* EC 3 VTs due to any of the following causes:\n\n  1. Idiopathic VT\n  2. Automaticity or triggered activity\n  3. Bundle Branch Reentry (BBR)\n  4. Any focal tachycardia (e.g., papillary, RVOT)\n  5. Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause\n* EC 4 NICM patients only, if any of the following apply:\n\n  1. Congenital condition that limits access to the left or right ventricles\n  2. Severe aortic or mitral stenosis, severe mitral regurgitation, or severe aortic insufficiency\n  3. Active inflammatory processes (e.g., myocarditis) within the past 120 days\n  4. Sarcoidosis\n  5. Hypertrophic cardiomyopathy\n  6. Drug- or alcohol-induced cardiomyopathy\n* EC 5 Any VT ablation within 4 weeks prior to enrollment\n* EC 6 More than one prior (\\>4 weeks) VT ablation or prior surgical treatment for VT within the past 2 years\n* EC 7 Cardiogenic shock, unless it is due to incessant monomorphic VT\n* EC 8 Any other cardiovascular conditions as described below:\n\n  1. Class IV heart failure\n  2. Aortic aneurysm\n  3. Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to index procedure\n  4. Interatrial baffle, closure device, patch, or PFO occlusion device\n  5. Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure\n  6. Acute MI or unstable angina in the previous 60 days\n  7. Mechanical mitral or aortic valve\n  8. Cardiac myxoma\n  9. Significant congenital heart disease\n* EC 9 Acute illness or active systemic infection\n* EC 10 Any previous history of cryoglobulinemia\n* EC 11 History of blood clotting or bleeding disease\n* EC 12 Peripheral vascular disease that precludes LV access\n* EC 13 Contraindication to heparin\n* EC 14 Allergy to radiographic contrast dye that cannot be medically managed prior to the ablation procedure\n* EC 15 Any prior history of documented cerebral vascular accident (CVA), TIA or systemic embolism (excluding a post-operative Deep Vein Thrombosis, DVT), within 6 months prior to the ablation procedure.\n* EC 16 Pregnant, or anticipated pregnancy during study follow-up\n* EC 17 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study\n* EC 18 Any other condition (e.g., ARVC with extensive free wall scarring) that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, candidate for heart transplantation, patient with ventricular assist device, or terminal illness with a life expectancy less than 12 months)",[115,116],"ADULT","OLDER_ADULT",[118,127,135,143,151,159,166,170,177,185,193,201,209,217,226],{"facility":119,"city":120,"state":121,"zip":122,"country":123,"geoPoint":124},"Banner University Medical Center Phoenix","Phoenix","Arizona","85006","United States",{"lat":125,"lon":126},33.44838,-112.07404,{"facility":128,"city":129,"state":130,"zip":131,"country":123,"geoPoint":132},"University of California San Francisco","San Francisco","California","94143",{"lat":133,"lon":134},37.77493,-122.41942,{"facility":136,"city":137,"state":138,"zip":139,"country":123,"geoPoint":140},"Johns Hopkins University","Baltimore","Maryland","21287",{"lat":141,"lon":142},39.29038,-76.61219,{"facility":144,"city":145,"state":146,"zip":147,"country":123,"geoPoint":148},"Brigham and Women's Hospital","Boston","Massachusetts","02115",{"lat":149,"lon":150},42.35843,-71.05977,{"facility":152,"city":153,"state":154,"zip":155,"country":123,"geoPoint":156},"University of Michigan","Ann Arbor","Michigan","48109",{"lat":157,"lon":158},42.27756,-83.74088,{"facility":160,"city":161,"state":161,"zip":162,"country":123,"geoPoint":163},"Icahn School of Medicine at Mount Sinai","New York","10029",{"lat":164,"lon":165},40.71427,-74.00597,{"facility":167,"city":161,"state":161,"zip":168,"country":123,"geoPoint":169},"Weill Cornell Medical Center","10065",{"lat":164,"lon":165},{"facility":171,"city":172,"state":161,"zip":173,"country":123,"geoPoint":174},"Northwell Health- Staten Island University Hospital","Staten Island","10305",{"lat":175,"lon":176},40.56233,-74.13986,{"facility":178,"city":179,"state":180,"zip":181,"country":123,"geoPoint":182},"Ohio State University","Columbus","Ohio","43210",{"lat":183,"lon":184},39.96118,-82.99879,{"facility":186,"city":187,"state":188,"zip":189,"country":123,"geoPoint":190},"Hospital of University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"lat":191,"lon":192},39.95238,-75.16362,{"facility":194,"city":195,"state":196,"zip":197,"country":123,"geoPoint":198},"Medical Center of South Carolina (MUSC)","Charleston","South Carolina","29403",{"lat":199,"lon":200},32.77632,-79.93275,{"facility":202,"city":203,"state":204,"zip":205,"country":123,"geoPoint":206},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"lat":207,"lon":208},36.16589,-86.78444,{"facility":210,"city":211,"state":212,"zip":213,"country":123,"geoPoint":214},"Texas Cardiac Arrhythmia Research Institute (TCARF)","Austin","Texas","78705",{"lat":215,"lon":216},30.26715,-97.74306,{"facility":218,"city":219,"state":220,"zip":221,"country":222,"geoPoint":223},"Montreal Heart Institute","Montreal","Quebec","H1T 1C8","Canada",{"lat":224,"lon":225},45.50884,-73.58781,{"facility":227,"city":219,"state":220,"zip":228,"country":222,"geoPoint":229},"McGill University","H4A 3J1",{"lat":224,"lon":225},[],[],[233],{"pmid":234,"type":235,"citation":236},"41623095","DERIVED","Weiss JP, Reddy VY, Tandri H, Richardson TD, Gerstenfeld EP, Stevenson WG, Jubran N, Grigorov I, Tung R. Ultra-Low Cryoablation for Scar-Related VT Ablation: Results From the US Early Feasibility Study. Circ Arrhythm Electrophysiol. 2026 Feb;19(2):e014095. doi: 10.1161\u002FCIRCEP.125.014095. Epub 2026 Feb 2.",[],{"nct_id":4,"conditions":239,"biomarkers":241},[240],"Ventricular Tachycardia",[],{"nct_id":4,"found":15,"summary":243,"prompt_version":252},{"design":244,"status":245,"heading":6,"summary":246,"follow_up":247,"word_count":248,"commitments":249,"compensation":250,"drugs_mentioned":251},"This is a single-arm study, meaning all participants will receive the Adagio VT Cryoablation System. It is an open-label study, so both you and your doctors will know you are receiving the study treatment. The study plans to enroll 206 participants.","completed","This study is testing a new device called the Adagio VT Cryoablation System to treat sustained monomorphic ventricular tachycardia (SMVT), a type of fast and irregular heartbeat. The Adagio system uses cryoablation (a procedure that uses extreme cold to destroy abnormal heart tissue) to stop these irregular heartbeats. Researchers want to see how safe and effective this device is for people with SMVT caused by heart disease. To join, you must be at least 18 years old, have SMVT that requires catheter ablation, and already have an implanted cardioverter defibrillator (ICD). The study will look at safety within 7 days of the procedure and how well the treatment works at 6 months.","Your safety will be monitored for 7 days after the procedure, and the effectiveness of the treatment will be assessed at 6 months after the procedure.",112,"You will undergo a cryoablation procedure using the investigational device. You must also have an Implantable Cardioverter Defibrillator (ICD) before the procedure.","Not stated in the trial record.",[],"v2"]