Strategies in Patients Undergoing Repeat AF Ablation

NCT ID: NCT05185310

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-13
• Study Completion Date: 2023-02-03

Brief Summary

The aim of the proposed research project is to compare the efficacy of three different ablation strategies in patients with atrial fibrillation (AF) who are undergoing their first repeat catheter ablation for recurrent AF.

Detailed Description

Reconnection of the pulmonary veins (PV) is generally responsible for AF recurrence in most cases. However, in a growing subset of patients undergoing repeat ablation for recurrent AF, the PVs are chronically isolated and no other non-PV triggers of AF can be identified. The investigators have previously shown that empirically ablating at known common non-PV trigger sites for AF can improve arrhythmia free survival beyond PVI. The left atrial (LA) posterior wall is also increasingly being isolated in AF patients undergoing catheter ablation. However, long term arrhythmia free survival in AF patients undergoing LA posterior wall isolation is not consistently better than PVI alone.

The objective of this study therefore is to assess whether performing empiric ablation of common non-PV trigger sites or achieving LA posterior wall isolation can improve arrhythmia free survival in AF patients who are undergoing repeat AF ablation and in whom the PV remain chronically isolated and/or do not demonstrate AF. The investigators propose to do this as prospective, randomized three arm study.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CTI/AAD (control)

In all arms, patients are undergoing first redo AF ablation and the pulmonary veins are chronically isolated and no non-PV triggers elicited during provocation. Arm 1- Cavo-tricuspid isthmus (CTI) ablation with adjustment and/or optimization of antiarrhythmic drug regimen where possible (control arm)

Group Type: EXPERIMENTAL

Ablation

Intervention Type: PROCEDURE

Ablation strategy during repeat AF ablation

Posterior wall isolation

In all arms, patients are undergoing first redo AF ablation and the pulmonary veins are chronically isolated and no non-PV triggers elicited during provocation. Arm 2-LA Posterior wall isolation by creation of a LA roof and floor line

Group Type: EXPERIMENTAL

Ablation

Intervention Type: PROCEDURE

Ablation strategy during repeat AF ablation

Empiric Isolation of common trigger sites

In all arms, patients are undergoing first redo AF ablation and the pulmonary veins are chronically isolated and no non-PV triggers elicited during provocation. Arm 3-empiric ablation of common sites of non-PV triggers of AF in both the right and left atria.

Group Type: EXPERIMENTAL

Ablation

Intervention Type: PROCEDURE

Ablation strategy during repeat AF ablation

Interventions

Ablation

Ablation strategy during repeat AF ablation

Intervention Type: PROCEDURE

Eligibility Criteria

Exclusion Criteria

1. Patients in whom ≥1 PVs have reconnected and AF triggers can be elicited from the reconnected PV.

2. Patients who demonstrated non-PV triggers for AF.

3. Patients who have experienced arrhythmia recurrence post ablation where the recurrent arrhythmia is other than atrial fibrillation or typical atrial flutter

4. Failure to obtain informed consent

5. Patients with a mechanical mitral valve

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Lin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Sanjay Dixit, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

IRB # 850051

Identifier Type: -

Identifier Source: org_study_id