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
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Atlanta, Georgia 30342
Principal Investigator: David DeLurgio, MD
Phone: 678-843-6093
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Austin, Texas 78756
Principal Investigator: David Tschopp, MD
Phone: 512-421-3860
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Baton Rouge, Louisiana 70808
Principal Investigator: Kenneth Civello, MD
Phone: 225-765-7733
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3690 Grandview Parkway
Birmingham, Alabama 35243
Birmingham, Alabama 35243
Principal Investigator: Jose Osorio, MD
Phone: 205-971-7578
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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...
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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...
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3535 Olentangy River Road
Columbus, Ohio 43214
Columbus, Ohio 43214
Principal Investigator: Sreedhar Billakanty, MD
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4567 E 9th Ave
Denver, Colorado 80220
Denver, Colorado 80220
Principal Investigator: Jason Sperling, MD
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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...
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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...
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521 Moye Boulevard
Greenville, North Carolina 27834
Greenville, North Carolina 27834
Principal Investigator: Andy Kiser, MD
Phone: 252-744-8482
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Harrisburg, Pennsylvania 17101
Principal Investigator: Michael G Link, MD
Phone: 717-731-0101
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Huntsville, Alabama 35801
Principal Investigator: Paul Tabereaux, MD
Phone: 256-519-8276
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Indianapolis, Indiana 46290
Principal Investigator: Jeffrey Olson, DO
Phone: 317-583-6115
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London, EC1A 7BE
Principal Investigator: Syed Ahsan, MD
Phone: 020 3765 8890
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Palm Beach Gardens, Florida 33410
Principal Investigator: David Weisman, MD
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Pittsburgh, Pennsylvania 15212
Principal Investigator: Amit Thosani, MD
Phone: 412-359-6860
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1900 Kildaire Farm Road
Raleigh, North Carolina 27518
Raleigh, North Carolina 27518
Principal Investigator: Pavlo Netrebko, MD
Phone: 919-231-6132
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Richmond, Virginia 23225
Principal Investigator: David Gilligan, MD
Phone: 804-323-4029
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San Antonio, Texas 78229
Principal Investigator: David Pederson, MD
Phone: 210-614-7827
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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...
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Tupelo, Mississippi 38801
Principal Investigator: Karl Crossen, MD
Phone: 662-377-7571
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Washington, District of Columbia
Principal Investigator: Manish Shah, MD
Phone: 202-877-0805
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