Study Description | Study Design | Arms and Interventions | Outcome Measures | Eligibility Criteria | Contacts and Locations | More Information

Study Description

Brief Summary: 

This is a multi-center, open label, randomized pivotal study evaluating the safety and efficacy of the EPi-Sense-AF Guided Coagulation System for the treatment of persistent AF patients, refractory or intolerant to at least one Class I and/or III Anti Arrhythmic Drug (AAD).

Detailed Description:

The objective of this randomized pivotal study is to evaluate the safety and efficacy of the AtriCure EPi-Sense®-AF Guided Coagulation System with VisiTrax® for the treatment of symptomatic persistent Atrial Fibrillation (AF) patients, refractory or intolerant to at least one Class I or Class III anti-arrhythmic drug (AAD). 153 subjects from up to 27 US and 3 OUS sites. Randomized 2:1.

The primary efficacy endpoint is success or failure to be AF/AT/AFL free absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3-month blanking period through the 12-month post procedure follow-up visit.

The primary safety endpoint is the incidence of major adverse events (MAEs) listed in the protocol for subjects undergoing the convergent procedure for the procedural to 30-day post procedure time period.

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Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 153 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Convergence Of Epicardial And Endocardial Radiofrequency (RF) Ablation For The Treatment Of Symptomatic Persistent AF
• Study Start Date: December 2013
• Estimated Primary Completion Date: August 2019
• Estimated Study Completion Date: August 2024

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Familial atrial fibrillation
MedlinePlus related topics: Atrial Fibrillation
U.S. FDA Resources

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Arms and Interventions

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Outcome Measures

Primary Outcome Measures:

1. AF/AT/Atrial Flutter(AFL) free absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage. [ Time Frame: 12 Months ]
   1. The primary efficacy endpoint is success or failure to be AF/AT/AFL free absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3 month blanking period through the 12 months post procedure follow-up visit.

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Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age > 18 years; < 80 years
• Left atrium < 6.0 cm
• Refractory or intolerant to one AAD (class I and/or III)
• Documentation of persistent AF
• Provided written informed consent

Exclusion Criteria:

• Patients requiring concomitant surgery
• Left ventricular ejection fraction < 40%
• Pregnant or planning to become pregnant during study
• Co-morbid medical conditions that limit one year life expectancy
• Previous cardiac surgery
• History of pericarditis
• Previous cerebrovascular accident (CVA), excluding fully resolved transient Ischemic attack (TIA)
• Patients who have active infection or sepsis
• Patients with esophageal ulcers strictures and varices
• Patients with renal dysfunction who are not on dialysis
• Patients who are contraindicated for anticoagulants
• Patients who are being treated for ventricular arrhythmias
• Patients who have had a previous left atrial catheter ablation for AF
• Patients with existing Implantable Cardioverter-Defibrillator (ICDs)
• Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment Not competent to legally represent him or herself

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Contacts and Locations

Locations: