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RF Ablation

RF Ablation for Atrial Fibrillation

N/A
Recruiting
Research Sponsored by AtriCure, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has symptomatic longstanding persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS Guidelines (> 12 months of continuous AF)
Refractory or intolerant to at least one AAD (class I and/or III)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial will evaluate the EPi-Sense® Guided Coagulation System for the treatment of patients with long-standing persistent atrial fibrillation who are refractory or intolerant to at least one Class I and/or III AAD.

Who is the study for?
This trial is for adults aged 18-79 with symptomatic long-standing persistent atrial fibrillation, who haven't responded to certain antiarrhythmic drugs. Participants must have a life expectancy over a year and a left atrium size ≤ 6.0 cm. Exclusions include pregnancy, severe heart failure, treatment for ventricular arrhythmias, recent participation in other trials, cognitive impairment affecting consent ability, and various medical conditions that could interfere with the study or are risks due to the procedure.Check my eligibility
What is being tested?
The CONVERGE PAS study tests the EPi-Sense® Guided Coagulation System's effectiveness and safety when used commercially on patients with long-standing persistent AF who don't respond well to standard treatments. It involves epicardial and endocardial radiofrequency ablation—a technique using heat energy to destroy problematic heart tissue causing irregular rhythms.See study design
What are the potential side effects?
Potential side effects may include complications from cardiac procedures like bleeding or infection at the incision site, damage to nearby structures such as blood vessels or esophagus during ablation, adverse reactions to anesthesia or anticoagulants used during surgery, and general risks associated with invasive cardiac interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had atrial fibrillation for more than a year.
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I have not responded to or cannot tolerate at least one type of heart rhythm medication.
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I am between 18 and 79 years old.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Freedom from AF/AFL/AT >30 seconds through 12 months absent new or increased dose of class I/III AAD.
Primary Safety Endpoint, Incidence of defined Major Adverse Events
Secondary outcome measures
Freedom from AF/AT/AFL >30 seconds with previously or intolerant failed class I/III AAD
Freedom from any AF/AFL/AT >30 seconds with or without a Class I/III AAD
Freedom from any AF/AFL/AT >30 seconds without a Class I/III
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hybrid ConvergentExperimental Treatment1 Intervention
Once the procedure intra-op exclusion conditions have been evaluated, the Epicardial linear lesions will be created endoscopically using the EPi-Sense®-Guided Coagulation System or EPi-Sense ST™ Coagulation System throughout the posterior left atrium and along the pericardial reflections from a trans-diaphragmatic or sub-xyphoid access without any chest incisions. An endocardial ablation catheter will be used to complete the isolation of the pulmonary veins and create a cavotricuspid lesion to prevent typical atrial flutter. Posterior and other linear lesions such as a roof lesion and mitral valve isthmus lesion will not be created during the endocardial component of the convergent procedure. Once the study lesion pattern has been created by coagulating cardiac tissue using the EPi-Sense®- Guided Coagulation System or EPi-Sense ST™ Coagulation System and the endocardial ablation catheter, the pulmonary veins must be evaluated for entrance and/or exit block to confirm isolation.

Find a Location

Who is running the clinical trial?

AtriCure, Inc.Lead Sponsor
41 Previous Clinical Trials
17,146 Total Patients Enrolled
27 Trials studying Atrial Fibrillation
8,102 Patients Enrolled for Atrial Fibrillation

Media Library

EPi-Sense Guided Coagulation System (RF Ablation) Clinical Trial Eligibility Overview. Trial Name: NCT05393180 — N/A
Atrial Fibrillation Research Study Groups: Hybrid Convergent
Atrial Fibrillation Clinical Trial 2023: EPi-Sense Guided Coagulation System Highlights & Side Effects. Trial Name: NCT05393180 — N/A
EPi-Sense Guided Coagulation System (RF Ablation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05393180 — N/A

Frequently Asked Questions

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

How many people fit the profile to be included in this experiment?

"The most recent information on clinicaltrials.gov reveals that this trial is still looking for patients. The posting date was April 13th, 2022 and the last update was September 14th, 2022. There is space for 325 individuals at 4 different sites."

Answered by AI

What is the main focus of this clinical trial?

"The primary outcome of this study, which will be observed over a 30-day period post-procedure, is the freedom from atrial fibrillation (AF), atrial flutter (AFL), and atrial tachycardia (AT) for greater than 30 seconds in 12 months without the need for a new or increased dose of class I/III antiarrhythmic drugs (AADs). Additionally, this trial will measure secondary outcomes including freedom from AF/AT/AFL >30 seconds with previously failed or intolerable class I/III AADs, which is defined as freedom from AF/AT"

Answered by AI

How many research institutions are testing this hypothesis?

"There are 4 locations recruiting patients for this clinical trial. The sites are MedStar Union Memorial Hospital in Baltimore, Emory Saint Joseph Hopsital in Atlanta, and Baycare Health Systems in Clearwater. There are also other recruiting sites located elsewhere."

Answered by AI

Are there any unfilled participant positions in this experiment?

"This clinical trial, as indicated by its listing on clinicaltrials.gov, is actively recruiting patients. The trial was originally posted on April 13th, 2022 and was most recently updated on September 14th, 2022."

Answered by AI

Are octogenarians welcome in this trial?

"Participants must be between 18-80 years old to take part in this experiment."

Answered by AI
~147 spots leftby Nov 2025