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Procedure

Catheter ablation for Atrial Fibrillation (PLEA Trial)

N/A
Waitlist Available
Led By Jorge E Romero, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
Patients undergoing first time procedure for AF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24 and 60 months
Awards & highlights

PLEA Trial Summary

This trial is comparing the safety and effectiveness of four different treatments for atrial fibrillation.

PLEA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You may experience symptoms such as irregular heartbeat, difficulty breathing, chest discomfort, tiredness, weakened heart function, or a combination of these symptoms.
Select...
You are having your first procedure for atrial fibrillation (AF).
Select...
You may experience symptoms such as fast or irregular heartbeat, difficulty breathing, chest pain, tiredness, or other similar symptoms.

PLEA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12, 24 and 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12, 24 and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
A composite of thromboembolic events, myocardial perforation, pulmonary vein stenosis, atrioesophageal fistula, left and right phrenic nerve paralysis, and other serious adverse events within 12 months post-procedure.
Freedom from documented AF/AT/AFL episodes and all-cause mortality after initial procedure
Secondary outcome measures
AF/AT/AFL Burden
All-cause mortality
Atrial contractility
+8 more

PLEA Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: PVI + PWI + LAAEI + CSIExperimental Treatment1 Intervention
Pulmonary vein isolation plus posterior wall isolation plus left atrial appendage electrical isolation plus coronary sinus isolation will be performed using radiofrequency energy
Group II: PVI + PWI + LAAEIExperimental Treatment1 Intervention
Pulmonary vein isolation plus posterior wall isolation plus left atrial appendage electrical isolation will be performed using radiofrequency energy
Group III: PVI + PWIExperimental Treatment1 Intervention
Pulmonary vein isolation plus posterior wall isolation will be performed using radiofrequency energy
Group IV: PVIActive Control1 Intervention
Pulmonary vein isolation alone will be performed using radiofrequency energy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Catheter ablation
2016
Completed Phase 4
~810

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
440 Previous Clinical Trials
581,487 Total Patients Enrolled
Biosense Webster, Inc.Industry Sponsor
121 Previous Clinical Trials
37,515 Total Patients Enrolled
80 Trials studying Atrial Fibrillation
28,130 Patients Enrolled for Atrial Fibrillation
Jorge E Romero, MDPrincipal InvestigatorMontefiore Medical Center/Albert Einstein College of Medicine

Frequently Asked Questions

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

What are the main goals of this research endeavor?

"According the trial sponsor, Biosense Webster, Inc., the primary outcome to be measured over a 12 month period is freedom from documented atrial fibrillation/atrial tachycardia episodes and all-cause mortality following initial procedure. Secondary outcomes include incidence of peri-procedural and post procedural complications such as stroke, pulmonary veins stenosis, cardiac perforation, esophageal injury etc; in addition to assessment of myocardial strain for evaluation of atrial contractility after catheter ablation."

Answered by AI

Are there any unfilled openings for volunteers in this experiment?

"According to clinicaltrials.gov, this trial is actively searching for participants. The research initiative was launched on the 16th of January 2020 and recently revised on the 2nd August 2022."

Answered by AI

What are the current venues for this trial?

"At this time, 10 sites across the country are taking on participants for this clinical trial. For example, there are centres in Bloomington, Larkspur and Austin among others. It is suggested that patients pick a location as near to them as possible to minimize travel requirements should they choose to take part."

Answered by AI

Am I eligible to be included in this clinical investigation?

"This research project is seeking 932 individuals with atrial fibrillation who are within the age range of 18 to 99. Qualified participants will be able to take part in this medical trial."

Answered by AI

How many individuals have opted to participate in this trial?

"To launch this trial, the sponsor Biosense Webster, Inc. will require a cohort of 932 qualified participants. The study's locations include Indiana University in Bloomington and MarinHealth Medical Center situated in Larkspur, California."

Answered by AI

Does this research protocol permit seniors to participate?

"According to the eligibility criteria, potential participants must fall between 18 and 99 years of age. Additionally, 11 studies have been conducted with minors while 473 trials focus on patients over 65."

Answered by AI

Who else is applying?

What state do they live in?
California
Alabama
What site did they apply to?
MarinHealth Medical Center
Grandview Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I take metoprolol and blood thinners and repatha and statins. I still experience heart palpitations.
PatientReceived 2+ prior treatments
~24 spots leftby Mar 2025