Clinical trial NCT00566787: Concomitant Treatment of Permanent Atrial Fibrillation
Official title: A Prospective, Multi-center Study With Case Matched Controls to Evaluate the Safety and Efficacy of the AtriCure Bipolar System for the Treatment of Continuous Atrial Fibrillation as Adjunct Therapy to Elective Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: AF
Atrial Fibrillation
afib
racing heart
cabg
valve
ablation
bipolar
radiofrequency
rf
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2007-12-04
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System


Eligibility criteria: Inclusion Criteria:

1. Male or Female subject between 18 to 80 years of age
2. Subject is scheduled to undergo elective cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including:

   * coronary artery bypass and/or
   * mitral valve surgery (repair or replacement)
   * aortic valve surgery (repair or replacement)
   * tricuspid valve surgery (repair or replacement)
3. Left Ventricular Ejection Fraction ≥ 30%
4. Subject is willing and able to provide written informed consent
5. Subject has a life expectancy of at least 2 years
6. Subject is willing and able to return for scheduled follow-up visits
7. TREATMENT SUBJECTS ONLY: Subject has a 3 month documented history of continuous atrial fibrillation
8. CONTROL SUBJECTS ONLY: Subject is not in atrial fibrillation at time of surgery

Exclusion Criteria:

1. Lone AF without indication(s) for concomitant CABG and/or mitral valve surgery, aortic valve surgery, tricuspid valve surgery or double valve surgery
2. Prior cardiac surgery (Redo -including previous ablation)
3. Patient requires atrial septal defect repair or any other concomitant open-heart procedure, other than CABG and/or mitral valve surgery; aortic valve surgery, tricuspid valve surgery or double valve surgery
4. Serum creatinine concentration greater than 2.0 mg/dl
5. Class IV NYHA heart failure symptoms and/or Class IV CCS anginal symptoms
6. Prior history of cerebrovascular accident within 6 months or at any time if there is residual neurologic deficit
7. Active infection
8. Known carotid artery stenosis greater than 80%
9. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
10. A known drug and/or alcohol addiction
11. Mental impairment or other conditions which may not allow the the subject to understand the nature, significance and scope of the study
12. Pregnancy or desire to get pregnant within 12 months of study enrollment
13. Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia

Primary outcomes:
measure: Primary efficacy endpoint is the proportion of treated patients who are free of atrial fibrillation without the need for anti-arrhythmic agents at the six-month follow-up visit.
timeFrame: 6 months
measure: The primary safety endpoint is the occurrence of serious adverse events that are considered to be associated with the Maze procedure.
timeFrame: 30 days
Secondary outcomes:
measure: The secondary efficacy endpoint is the proportion of patients in the treatment group who are free of atrial fibrillation independent of the need for anti-arrhythmic drugs.
timeFrame: 6 Months
measure: The secondary safety endpoints are: total cross clamp time, total time on bypass, length of hospital stay (days), and length of ICU stay (hours)
timeFrame: Discharge
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Heart Center of Indiana
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk Hospital
state: Virginia
city: Seattle
country: United States
facility: Sacred Heart Medical Center
state: Washington
city: Madison
country: United States
facility: St. Mary's Hospital Medical Center
state: Wisconsin
Study officials:
affiliation: The Cleveland Clinic
name: A. Marc Gillinov, MD
role: PRINCIPAL_INVESTIGATOR
References: