Endocardial Vs Epicardial Ablation for Recurrent Paroxysmal AF

NCT04506814 | Withdrawn FDA Device

• 1 other identifier: UR Re-ablation Paroxysmal AF
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 redo PVI with hybrid epicardial ablation incorporating posterior wall isolation and LAA clip, and redo PVI.

Conditions

Recurrent Paroxysmal Atrial Fibrillation Despite Prior Pulmonary Vein Isolation

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation > 30 secs

  Based on serial 7-day Holter recordings

  At 1 year

Study Arms (2)

Endocardial PVI

ACTIVE COMPARATOR

Endocardial complete PVI

Device: Endocardial PVI

Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI

EXPERIMENTAL

Minimally invasive surgical hybrid ablation using the convergent approach plus LAA exclusion using the clip

Device: Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI

Interventions

Endocardial PVI DEVICE

Catheter based PVI

Endocardial PVI

Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI DEVICE

Minimally invasive PVI with posterior wall RF ablation + LAA clip + endocardial PVI

Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Meshalkin Research Institute of Pathology of Circulation: collaborator

Study Sites (1)

University of Rochester

Short Hills, New Jersey, 07078, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Collaborator

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 10, 2020
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)