Strategies in Patients Undergoing Repeat AF Ablation (TRAP-AF)

University of Pennsylvania

Status: Terminated

Conditions: Atrial Fibrillation

Treatments: Procedure: Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05185310

IRB # 850051

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: All patients undergoing first redo AF ablation who have chronically isolated pulmonary veins and no non-PV triggers with provocation testing (randomized intra-procedure).

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

8 participants in 3 patient groups

CTI/AAD (control)

Experimental group

Description:

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)

Treatment:

Procedure: Ablation

Posterior wall isolation

Experimental group

Description:

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

Treatment:

Procedure: Ablation

Empiric Isolation of common trigger sites

Experimental group

Description:

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.

Treatment:

Procedure: Ablation