search
Back to results

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

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ablation
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring pulmonary vein ablation, repeat ablation, posterior wall isolation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital of the University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

CTI/AAD (control)

Posterior wall isolation

Empiric Isolation of common trigger sites

Arm 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)

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Secondary endpoint
Composite: Freedom from atrial arrhythmias at 1 year after 1 repeat ablation procedure off antiarrhythmic medications; AF related interventions and hospitalizations (electrical cardioversion, increase or change in antiarrhythmic medication, repeat ablation, hospitalization for complication, etc). 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, hospitalizations (including repeat ablations and cardioversion), arrhythmia symptoms, and ECG and monitor results documented.

Full Information

First Posted
December 20, 2021
Last Updated
January 24, 2023
Sponsor
University of Pennsylvania
search

1. Study Identification

Unique Protocol Identification Number
NCT05185310
Brief Title
Strategies in Patients Undergoing Repeat AF Ablation
Acronym
TRAP-AF
Official Title
Strategies in Patients Undergoing Repeat AF Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
pulmonary vein ablation, repeat ablation, posterior wall isolation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single blinded randomized trial comparing 3 ablation strategies
Masking
Participant
Masking Description
patients will be blinded to strategy used
Allocation
Randomized
Enrollment
147 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CTI/AAD (control)
Arm Type
Experimental
Arm 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)
Arm Title
Posterior wall isolation
Arm Type
Experimental
Arm 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
Arm Title
Empiric Isolation of common trigger sites
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Ablation
Intervention Description
Ablation strategy during repeat AF ablation
Primary Outcome Measure Information:
Title
Primary efficacy endpoint
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Secondary endpoint
Description
Composite: Freedom from atrial arrhythmias at 1 year after 1 repeat ablation procedure off antiarrhythmic medications; AF related interventions and hospitalizations (electrical cardioversion, increase or change in antiarrhythmic medication, repeat ablation, hospitalization for complication, etc). 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, hospitalizations (including repeat ablations and cardioversion), arrhythmia symptoms, and ECG and monitor results documented.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Lin, MD
Phone
215-662-3999
Email
david.lin@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Gnap, RN
Phone
215-662-3999
Email
Mary.gnap@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Lin, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sanjay Dixit, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Gnap, RN
Phone
215-662-3999
Email
mary.gnap@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
David Lin, MD
Phone
215-662-3999
Email
david.lin@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
David Lin, MD
First Name & Middle Initial & Last Name & Degree
Sanjay Dixit, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Strategies in Patients Undergoing Repeat AF Ablation

We'll reach out to this number within 24 hrs