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Procedure

Ablation Strategies for Atrial Fibrillation (TRAP-AF Trial)

N/A
Waitlist Available
Led By David Lin, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients undergoing first redo AF ablation who have chronically isolated pulmonary veins and no non-PV triggers with provocation testing (randomized intra-procedure)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

TRAP-AF Trial Summary

This trial will compare the effectiveness of three different methods for treating atrial fibrillation by looking at how well patients do after having the procedure a second time.

Who is the study for?
This trial is for patients with atrial fibrillation who are having their first repeat catheter ablation because the initial one didn't work. They should have isolated pulmonary veins without any non-pulmonary vein triggers of AF. Those with reconnected pulmonary veins, other types of arrhythmias post-ablation, or a mechanical mitral valve can't join.Check my eligibility
What is being tested?
The study is testing three different strategies for performing catheter ablation on patients whose atrial fibrillation has returned after an initial ablation. The goal is to find out which method works best at preventing AF from coming back.See study design
What are the potential side effects?
Catheter ablation may cause complications like bleeding or bruising at the site where the catheter was inserted, damage to blood vessels or heart tissue, and in rare cases more serious heart rhythm problems.

TRAP-AF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having my first repeat AF ablation, with isolated pulmonary veins and no other heart rhythm triggers found.

TRAP-AF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary efficacy endpoint
Secondary outcome measures
Secondary endpoint

Side effects data

From 2015 Phase 2 trial • 260 Patients • NCT00903370
19%
Cardiac conduction abnormalities requiring PPM
14%
Arrhythmias-Sustained supraventricular arrhythmia
11%
Heart Failure
8%
Pleural Effusion
6%
Major Infection - Localized - Other
6%
Major Infection - Sepsis
5%
Bleeding
5%
Respiratory Failure
3%
Arrhythmias-Sustained ventricular arrhythmia
3%
Pericardial Fluid Collection
3%
Renal Failure (dialysis)
3%
Pneumothorax
2%
Neurological Dysfunction - Toxic Metabolic Encephalopathy
2%
Neurological Dysfunction - Other (not stroke, TIA, Toxic Metabolic Encephalopathy)
2%
Renal Dysfunction (no dialysis)
2%
Major Infection - Localized - Pneumonia
2%
Neurological Dysfunction - CVA-Ischemic
2%
Hepatic Dysfunction
2%
Myocardial Infarction
2%
Venous Thromboembolism Event
1%
Non-infectious Pericarditis
1%
Major Infection - Endocarditis
1%
Neurological Dysfunction - CVA-Hemorrhagic
1%
Right Heart Failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
MVS + Ablation
MVS Alone

TRAP-AF Trial Design

3Treatment groups
Experimental Treatment
Group I: Posterior wall isolationExperimental Treatment1 Intervention
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 II: Empiric Isolation of common trigger sitesExperimental Treatment1 Intervention
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 III: CTI/AAD (control)Experimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Ablation
2010
Completed Phase 4
~1390

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,992 Previous Clinical Trials
42,875,352 Total Patients Enrolled
16 Trials studying Atrial Fibrillation
2,823 Patients Enrolled for Atrial Fibrillation
David Lin, MDPrincipal InvestigatorUniversity of Pennsylvania
Sanjay Dixit, MDPrincipal InvestigatorUniversity of Pennsylvania
5 Previous Clinical Trials
566 Total Patients Enrolled
5 Trials studying Atrial Fibrillation
566 Patients Enrolled for Atrial Fibrillation

Media Library

Catheter Ablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05185310 — N/A
Atrial Fibrillation Research Study Groups: CTI/AAD (control), Posterior wall isolation, Empiric Isolation of common trigger sites
Atrial Fibrillation Clinical Trial 2023: Catheter Ablation Highlights & Side Effects. Trial Name: NCT05185310 — N/A
Catheter Ablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05185310 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cumulative scope of participants in this medical research?

"Affirmative. According to information posted on clinicaltrials.gov, this experiment is ongoing with its commencement recorded as December 13th 2021 and the most recent update being January 10th 2022. A total of 147 participants are anticipated for recruitment at one location."

Answered by AI

Is there currently an initiative to enroll participants in this clinical trial?

"Affirmative. Information on clinicaltrials.gov reveals that this medical trial is still actively searching for participants, having first been posted in December 13th 2021 and updated as recently as January 10th 2022. The study seeks to recruit 147 individuals from a single site."

Answered by AI

Who else is applying?

What site did they apply to?
Hospital of the University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
~2 spots leftby Mar 2025