[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07110922":3,"trial-entities:NCT07110922":93,"trial-summary:NCT07110922":97},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":45,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":64,"locations":67,"central_contacts":83,"overall_officials":87,"references":91,"see_also_links":92},"NCT07110922","2025-0403","Angiography and Electrogram Guided Bachmann Bundle Pacing","Angiography and Electrogram Guided Bachmann Bundle Pacing - ANGEL BBP","RECRUITING","2027-12-26","2025-09","2025-09-22","2025-08-15","Pugazhendhi Vijayaraman","OTHER",false,"People eligible for this study are scheduled to have a permanent pacemaker (PPM) or defibrillator device (ICD) implanted as part of their routine care. This device will also have a wire placed in the right atrium (RA) of the heart. As an alternative to the RA, the wire can also be placed in the Bachmann bundle (BB).\n\nThis study is being done to compare two options to help place the wire in the Bachmann bundle. One option uses contrast dye and x-ray, and the other option uses electrocardiogram (ECG) and contrast dye and x-ray. We want to learn more about how well these options work in implanting the wire in the Bachmann bundle.\n\nBoth of these options are FDA approved and used in standard practice.","The ANGEL BBP study is a prospective, single-center, randomized, controlled research study. The study team will identify all patients who satisfy the inclusion and exclusion criteria. The study team will evaluate the feasibility and success rates of Angiography guided Bachmann bundle pacing (BBP) lead implantation compared to traditional approach.\n\nEligible patients would undergo BBP using Medtronic 3830 lead and C304 or C315 family of sheaths. BBP will be confirmed at implant using Bachmann bundle potentials recorded from the lead, ECG 'P' wave morphology and duration during atrial pacing, fluoroscopic locations on right anterior oblique (RAO) and left anterior oblique (LAO) projections.\n\nDuring implant procedure, 5-10 ml of contrast will be used to perform inferior superior vena cava (SVC) angiogram via the lead delivery sheath in RAO and LAO views. The pacing lead will be then implanted using these images as guidance along with recording of local electrograms from the pacing lead.\n\nThe study team will randomize 50 patients who satisfy inclusion and exclusion criteria. The study team will compare the difference in procedural success between Angiography and Electrogram guided BBP and Electrogram\u002FECG only guided BBP patients.",[19],"Heart Diseases",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},50,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DIAGNOSTIC_TEST","Angiography only","Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region",[31],{"type":30,"name":35,"description":36,"armGroupLabels":37},"Angiography and ECG","Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region and correlate with electrogram guidance for BBP",[35],[39,42],{"measure":40,"timeFrame":41},"Success of Bachmann bundle pacing using angiography at implant","Perioperative",{"measure":43,"description":44,"timeFrame":41},"Change in implant procedure duration","Change in implant procedure duration between the two arms",[46,50,53],{"measure":47,"description":48,"timeFrame":49},"Atrial pacing parameters","atrial pacing parameters include threshold, sensing and impedance measured by device interrogation","3 month follow up",{"measure":51,"description":52,"timeFrame":49},"Paced P-wave morphology compared to native P-waves","P-wave morphology is measured via ECG at follow up and compared to native P-waves from baseline ECG",{"measure":54,"description":55,"timeFrame":49},"Paced P-wave duration compared to native P-waves","P-wave duration is measured via ECG at follow up and compared to native P-waves from baseline ECG","ALL","18 Years",null,true,{"inclusion":61,"exclusion":62,"raw_text":63},[],[],"Inclusion Criteria:\n\n1. Patients \\> 18 years of age\n2. Patient with an indication for permanent pacemaker or ICD utilizing atrial pacing lead\n3. Patient is willing to comply with all study procedures and be available for the duration of the study.\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\n2. Pregnant\n3. Enrolled in a concurrent study that may confound the results of this study.\n4. Persistent atrial fibrillation at the time of implant (if cardioversion contraindicated at the time of implant, where BB mapping cannot be performed in sinus rhythm)\n5. Renal dysfunction with serum Creatinine \\>3.0 mg\u002Fdl",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":69,"status":8,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":80},"Geisinger Wyoming Valley","Wilkes-Barre","Pennsylvania","18711","United States",[75],{"name":76,"role":77,"phone":78,"email":79},"Vijayaraman Pugazhendi, MD","CONTACT","5708086020","pvijayaraman1@geisinger.edu",{"lat":81,"lon":82},41.24591,-75.88131,[84],{"name":85,"role":77,"phone":86,"email":79},"Pugazhendhi Vijayaraman, MD","570-808-6020",[88],{"name":85,"affiliation":89,"role":90},"Geisinger Clinic","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":94,"biomarkers":96},[95],"Heart Disorder",[],{"nct_id":4,"found":59,"summary":98,"prompt_version":107},{"design":99,"status":100,"heading":6,"summary":101,"follow_up":102,"word_count":103,"commitments":104,"compensation":105,"drugs_mentioned":106},"This is a prospective, single-center, randomized study planning to enroll 50 participants. Participants will be randomly assigned to one of the two guidance methods.","completed","This study is for people who need a permanent pacemaker or defibrillator (ICD) and will have a wire placed in the right atrium of their heart. Researchers are comparing two ways to guide the placement of this wire into a specific area called the Bachmann bundle (BB). One method uses contrast dye and X-rays (Angiography only), and the other uses both X-rays with contrast dye and electrical signals from the heart (Angiography and ECG). Both methods are already approved and used in standard care. The goal is to see how well each method works to successfully place the wire in the Bachmann bundle and how long the procedure takes. You can join if you are over 18, need a pacemaker or ICD with an atrial pacing lead, and are willing to follow study procedures. The current status of this study is unclear.","The primary outcomes of the study are measured during the perioperative period (around the time of surgery).",142,"You would undergo the standard pacemaker or ICD implantation procedure, with the lead placed using one of the two guidance methods being studied. The study will assess the success of lead placement and procedure duration during this perioperative period.","Not stated in the trial record.",[31,35],"v2"]