Status:
WITHDRAWN
Endocardial Vs Epicardial Ablation for Recurrent Paroxysmal AF
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Meshalkin Research Institute of Pathology of Circulation
Conditions:
Recurrent Paroxysmal Atrial Fibrillation Despite Prior Pulmonary Vein Isolation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
There is no current accepted and predictably effective ablative therapy for patients with recurrent paroxysmal atrial fibrillation after prior pulmonary vein isolation (PVI). This study will compare r...
Detailed Description
In these redo ablation patients, the ideal re-ablation strategy is unknown and many techniques have been proposed but there is no consensus nor strong clinical trial data. This treatment gap prompted...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age \> 18 years
- Symptomatic paroxysmal AF despite prior 1 or 2 PVI procedures within past 10 years (paroxysmal AF lasting up to 7 days before spontaneous termination)
- Eligible for referral for re-ablation based on current guidelines
- LA diameter \< 6.0 cms on transthoracic echo
- Willingness to comply with 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, contraindication to anticoagulation)
- Prior history of open heart surgery
- Prior history of pericarditis or pericardiocentesis
- Prior history of stroke/TIA/systemic embolism
- NYHA class IV congestive heart failure or LVEF \< 25%
- Persistent or longstanding persistent AF (duration \> 1 year)
- Coronary revascularization or valve surgery within 3 months
- Prior valve surgery using a mechanical prosthesis
- An estimated glomerular filtration rate (eGFR) \< 45mL/min/1.73m2, using the MDRD calculation
- Life expectancy \<1 year for any medical condition
- AF due to reversible cause e.g. hyperthyroid state
- Women who are pregnant or plan to become pregnant during the course of the trial\*\* Note: Women of childbearing potential must have a negative pregnancy test within 7 days prior to randomization.
- Participation in other clinical trials that will affect the objectives of this study
- History of non-compliance to medical therapy
- 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 :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04506814
Start Date
January 1 2025
End Date
January 1 2028
Last Update
November 9 2023
Active Locations (1)
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1
University of Rochester
Short Hills, New Jersey, United States, 07078