CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 9/27/2018 |
| Start Date: | December 2013 |
| End Date: | August 2024 |
Convergence Of Epicardial And Endocardial Radiofrequency (RF) Ablation For The Treatment Of Symptomatic Persistent AF
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).
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).
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.
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.
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
We found this trial at
26
sites
1 Genesys Pkwy
Grand Blanc, Michigan 48439
Grand Blanc, Michigan 48439
(810) 606-5000
Principal Investigator: Marc Silver, MD
Phone: 810-606-7713
Genesys Regional Medical Center Genesys Health System, a member of Ascension Health, is a group...
Click here to add this to my saved trials
Click here to add this to my saved trials
Atlanta, Georgia 30342
Principal Investigator: David DeLurgio, MD
Phone: 678-843-6093
Click here to add this to my saved trials
Austin, Texas 78756
Principal Investigator: David Tschopp, MD
Phone: 512-421-3860
Click here to add this to my saved trials
Baton Rouge, Louisiana 70808
Principal Investigator: Kenneth Civello, MD
Phone: 225-765-7733
Click here to add this to my saved trials
3690 Grandview Parkway
Birmingham, Alabama 35243
Birmingham, Alabama 35243
Principal Investigator: Jose Osorio, MD
Phone: 205-971-7578
Click here to add this to my saved trials
4802 10th Ave
Brooklyn, New York 11219
Brooklyn, New York 11219
(718) 283-6000
Principal Investigator: Yisachar Greenberg, MD
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
Click here to add this to my saved trials
41 Mall Road
Burlington, Massachusetts 1805
Burlington, Massachusetts 1805
781-744-5100
Principal Investigator: Bruce G Hook, MD
Phone: 781-744-1901
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
Click here to add this to my saved trials
3535 Olentangy River Road
Columbus, Ohio 43214
Columbus, Ohio 43214
Principal Investigator: Sreedhar Billakanty, MD
Click here to add this to my saved trials
4567 E 9th Ave
Denver, Colorado 80220
Denver, Colorado 80220
Principal Investigator: Jason Sperling, MD
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Mani Daneshmand, MD
Phone: 919-684-4491
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Click here to add this to my saved trials
521 Moye Boulevard
Greenville, North Carolina 27834
Greenville, North Carolina 27834
Principal Investigator: Andy Kiser, MD
Phone: 252-744-8482
Click here to add this to my saved trials
Harrisburg, Pennsylvania 17101
Principal Investigator: Michael G Link, MD
Phone: 717-731-0101
Click here to add this to my saved trials
Huntsville, Alabama 35801
Principal Investigator: Paul Tabereaux, MD
Phone: 256-519-8276
Click here to add this to my saved trials
Indianapolis, Indiana 46290
Principal Investigator: Jeffrey Olson, DO
Phone: 317-583-6115
Click here to add this to my saved trials
Click here to add this to my saved trials
London, EC1A 7BE
Principal Investigator: Syed Ahsan, MD
Phone: 020 3765 8890
Click here to add this to my saved trials
Click here to add this to my saved trials
Palm Beach Gardens, Florida 33410
Principal Investigator: David Weisman, MD
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15212
Principal Investigator: Amit Thosani, MD
Phone: 412-359-6860
Click here to add this to my saved trials
1900 Kildaire Farm Road
Raleigh, North Carolina 27518
Raleigh, North Carolina 27518
Principal Investigator: Pavlo Netrebko, MD
Phone: 919-231-6132
Click here to add this to my saved trials
Richmond, Virginia 23225
Principal Investigator: David Gilligan, MD
Phone: 804-323-4029
Click here to add this to my saved trials
San Antonio, Texas 78229
Principal Investigator: David Pederson, MD
Phone: 210-614-7827
Click here to add this to my saved trials
475 Seaview Ave
Staten Island, New York 10305
Staten Island, New York 10305
(718) 226-9000
Principal Investigator: Marcin Kowalski, MD
Phone: 917-617-6004
Staten Island University Hospital Staten Island University Hospital is a 714-bed, specialized teaching hospital located...
Click here to add this to my saved trials
Tupelo, Mississippi 38801
Principal Investigator: Karl Crossen, MD
Phone: 662-377-7571
Click here to add this to my saved trials
Washington, District of Columbia
Principal Investigator: Manish Shah, MD
Phone: 202-877-0805
Click here to add this to my saved trials