Concomitant Treatment of Permanent Atrial Fibrillation (RESTORE SR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.
ClinicalTrials.gov Identifier:
NCT00566787
First received: December 3, 2007
Last updated: January 23, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Atrial Fibrillation
Device: Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The primary safety endpoint is the occurrence of serious adverse events that are considered to be associated with the Maze procedure. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • The secondary safety endpoints are: total cross clamp time, total time on bypass, length of hospital stay (days), and length of ICU stay (hours) [ Time Frame: Discharge ] [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: January 2005
Study Completion Date: November 2010
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
    Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566787

Locations
United States, Indiana
Heart Center of Indiana
Indianapolis, Indiana, United States, 46290
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Spectrum Health
Grand Rapids, Michigan, United States, 49506
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
United States, Virginia
Sentara Norfolk Hospital
Norfolk, Virginia, United States, 23507
United States, Washington
Sacred Heart Medical Center
Seattle, Washington, United States, 99220
United States, Wisconsin
St. Mary's Hospital Medical Center
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
AtriCure, Inc.
Investigators
Principal Investigator: A. Marc Gillinov, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT00566787     History of Changes
Other Study ID Numbers: CP2003-1
Study First Received: December 3, 2007
Last Updated: January 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AtriCure, Inc.:
AF
Atrial Fibrillation
afib
racing heart
cabg
valve
ablation
bipolar
radiofrequency
rf

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014