Strategies in Patients Undergoing Repeat AF Ablation

NCT05185310 | Terminated

• 1 other identifier: IRB # 850051
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

pulmonary vein ablation; repeat ablation; posterior wall isolation

Outcome Measures

Primary Outcomes (1)

• Primary efficacy endpoint

  Freedom from atrial arrhythmias off antiarrhythmic medications at 1 year after 1 repeat ablation procedure. Subjects are seen at 6 weeks, 6 months and 1 year post procedure with ECG at each visit and monitors at 6 months and one year to assess efficacy. Information regarding medications, health status, arrhythmia symptoms, and ECG and monitor results documented.

  1 year

Secondary Outcomes (1)

• Secondary endpoint

  1 year

Study Arms (3)

CTI/AAD (control)

EXPERIMENTAL

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)

Procedure: Ablation

Posterior wall isolation

EXPERIMENTAL

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

Procedure: Ablation

Empiric Isolation of common trigger sites

EXPERIMENTAL

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.

Procedure: Ablation

Interventions

Ablation PROCEDURE

Ablation strategy during repeat AF ablation

CTI/AAD (control); Empiric Isolation of common trigger sites; Posterior wall isolation

Eligibility Criteria

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

You may not qualify if:

• Patients in whom ≥1 PVs have reconnected and AF triggers can be elicited from the reconnected PV.
• Patients who demonstrated non-PV triggers for AF.
• Patients who have experienced arrhythmia recurrence post ablation where the recurrent arrhythmia is other than atrial fibrillation or typical atrial flutter
• Failure to obtain informed consent
• Patients with a mechanical mitral valve

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Lin, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Sanjay Dixit, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patients will be blinded to strategy used
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single blinded randomized trial comparing 3 ablation strategies

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 11, 2022
• Study Start: December 13, 2021
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

US (1)