N/A N=170 Randomized Treatment

CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)

Persistent Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT01984346 ↗

Enrolled (actual)

170

Serious AEs

90.2%

Results posted

Feb 2022

Primary outcome: Primary: Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL. — 67; 25 Participants — p=0.0472

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax (Device); Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AtriCure, Inc.
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL.	67; 25	0.0472 sig
PRIMARY Primary Safety Analysis	8; 0	—
SECONDARY Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure.	4; 0; 4; 0; 3; 0	—
SECONDARY Number of Patients With AF Burden Reduction of at Least 90% at 12 Months Compared to Baseline	60; 25	—
SECONDARY AF Freedom Through 12 Months- Absent of an Increased Dose or New Class I/III AAD's.	71; 51	—
SECONDARY Number of Subjects With AF Burden Reduction of at Least 90% at 12 Months Relative to Baseline, Regardless of Class I/III AADs.	95; 88.6	—
SECONDARY Change in Atrial Fibrillation Severity Scale (AFSS)	-11.7; -10.3	—
SECONDARY Change in Quality of Life Physical Health Composite Scores Using Short Form Health Survey (SF-36)	7.3; 5.7	—
SECONDARY Quality of Life-Change in SF-36 Mental Health Composite Score Using Short Form Survey (SF-36)	5.7; 7.7	—
SECONDARY Change in 6-Minute Walk Score	9.2; -12.4	—
SECONDARY Change in Left Atrial Diameter	0.1; 1.9	—

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).

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01984346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.