Status:
NOT_YET_RECRUITING
Comparative Effectiveness of Different Techniques for Repeat Ablation of Atrial Fibrillation
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Atrial Fibrillation (AF)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Atrial fibrillation (AF) is the most common type of irregular heartbeat doctors see. People with AF sometimes have a procedure called an ablation to help get their heart back into a normal rhythm. How...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age ≥ 18 years on date of consent
- One prior PVI ablation procedure \> 3 months prior for persistent AF
- Recurrent paroxysmal or persistent symptomatic AF confirmed on ECG despite prior PVI
- Eligible for repeat ablation procedure
- Willingness to comply with all post-procedural follow-up requirements and to sign informed consent
- Exclusion Criteria
- Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus)
- Prior ablation that included non-PVI LA ablation, or more than one prior PVI ablation procedure for persistent AF
- Prior surgical ablation for AF
- Contraindication to systematic anticoagulation
- LA diameter on echocardiogram \> 6.0 cms
- LV ejection fraction \< 35%
- NYHA class III-IV congestive heart failure
- Acute coronary syndrome or coronary artery bypass surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within 3 calendar months prior to consent date
- Enzyme-positive myocardial infarction within the past 3 calendar months prior to consent
- Severe aortic or mitral valvular heart disease eligible for percutaneous or surgical repair/replacement procedures
- Prior valve replacement with mechanical prosthesis
- Angiographic evidence of coronary disease that requires coronary revascularization and with likelihood of undergoing a CABG or PCI in the next 3 calendar months following consent date
- Stroke within 3 calendar months prior to consent date
- Any medical condition likely to limit survival to \< 1 year
- Renal failure requiring dialysis at time of consent
- Pregnancy
- History of non-compliance to medical therapy
- Participation in other clinical trials (observational/lead registries are allowed) without approval from the CCRC
- Inability or unwillingness to provide informed consent
- Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult
- Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial
Exclusion
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT06988202
Start Date
November 1 2025
End Date
December 31 2031
Last Update
November 7 2025
Active Locations (1)
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1
University of Rochester Clinical Cardiovascular Research Center
Rochester, New York, United States, 14642