Low Voltage-Directed Catheter Ablation for Atrial Fibrillation

This study is looking at two different approaches to catheter ablation for symptomatic non-paroxysmal atrial fibrillation (a type of irregular heartbeat that doesn't go away on its own). It compares a procedure called pulmonary vein isolation (PVI) alone, to PVI combined with an additional low voltage-directed ablation. The goal is to see which approach is better at preventing your atrial fibrillation from coming back. You may be able to join if you are between 18 and 85 years old, have non-paroxysmal atrial fibrillation, and have not responded to at least one antiarrhythmic drug. The study will measure success by how long you remain free from any irregular heart rhythm (atrial fibrillation, atrial flutter, or atrial tachycardia) for one year after the procedure. The current status of this study is unclear.

Study design: This interventional study plans to enroll 250 participants. If you have low voltage in your heart, you will be randomly assigned to receive either PVI with additional low voltage-directed ablation or PVI alone.
What's involved: You will undergo an ablation procedure. You will also have continuous monitoring for heart arrhythmias, possibly with an implantable loop recorder, at 6, 9, and 12 months after the procedure.
Compensation: Not stated in the trial record.
Follow-up: You will be followed for one year after the ablation procedure to check for any return of your heart rhythm problems.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Low Voltage-Directed Catheter Ablation for Atrial Fibrillation

Recruiting

NAAges 18–85InterventionalTreatment

Ohad Ziv

~250 participants

Updated 2024-06-10 on ClinicalTrials.gov

What's tested:Radiofrequency ablation

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Freedom from first arrhythmia recurrence defined as sustained symptomatic or asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia.

Measured over Any event between the 3 month blanking period and 1 year post-ablation.

Conditions

Atrial Fibrillation - Symptomatic

NCT03355456

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

MetroHealth Medical Center
Cleveland, Ohiostudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Ohad Ziv, MD · PRINCIPAL_INVESTIGATOR · MetroHealth System, Ohio

Who to contact

Peter Leo BS, RN

[email protected]

216-778-2714

Email the study team

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Eligibility criteria

Exclusion

Prior ablation for typical atrial flutter or left-sided ablation for WPW, AV node reentry tachycardia or focal ectopic atrial tachycardia may be included. 2. Uncontrolled heart Failure or NYHA Class IIIb or IV heart failure. 3. Ejection Fraction \< 0.20. 4. Active ventricular tachycardia requiring treatment with catheter ablation or anti-arrhythmic drug within the last 6 months. 5. Left atrial size \> 60 mm diameter on echocardiogram. 6. "Long standing" persistent AF defined as \> or = 1 year of continuous atrial fibrillation at the time of enrollment. 7. Severe pulmonary hypertension (PAP \> 70 mmHg) 8. Unstable valvular disease. 9. AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause. 10. Poor candidate for general anesthesia. 11. Anticipated survival \< 1 year. 12. MI or CABG within 3 months. 13. Left atrial thrombus in pre-procedure imaging within 4 weeks of the ablation procedure. 14. Any documented thromboembolic event within 6 months of the ablation procedure. 15. Contraindication to anticoagulation. 16. Inability to have implantable monitoring device for atrial fibrillation burden with no pre-existing cardiac device that can monitor atrial arrhythmias OR inability to wear external Holter Monitor continuously for 4 weeks. 17. Significant congenital anomaly or medical condition that may affect the integrity of study data. 18. Women who are pregnant - pregnancy test required if pre-menopausal or non-sterile. 19. Active enrollment in another investigational study involving a drug or device. 20. Inability to undergo complete voltage mapping in normal sinus rhythm - see intraprocedural protocol. 21. Presence of any medical or psychological condition or medical non-compliance history that may adversely impact study outcomes.

What this trial measures

Freedom from first arrhythmia recurrence defined as sustained symptomatic or asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia.Any event between the 3 month blanking period and 1 year post-ablation.
The primary endpoint is freedom from sustained symptomatic or asymptomatic atrial arrhythmia (atrial fibrillation, atrial flutter or atrial tachycardia - AT/AF) i.e.; NO change from sinus rhythm to atrial arrhythmia between 3 -12 months after ablation. Recurrence of AF/AT excludes the 3 month blanking period. Sustained AF/AT is defined as \>30 seconds as recorded on a monitoring device.

Trialytics