Concomitant Treatment of Permanent Atrial Fibrillation (RESTORE SR)

January 23, 2012 updated by: AtriCure, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Heart Center of Indiana
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Grand Rapids, Michigan, United States, 49506
        • Spectrum Health
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk Hospital
    • Washington
      • Seattle, Washington, United States, 99220
        • Sacred Heart Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • St. Mary's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months
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
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 Months
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
Discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AtriCure, Inc.

Investigators

  • Principal Investigator: A. Marc Gillinov, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

December 3, 2007

First Submitted That Met QC Criteria

December 3, 2007

First Posted (ESTIMATE)

December 4, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 25, 2012

Last Update Submitted That Met QC Criteria

January 23, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP2003-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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