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Concomitant Treatment of Permanent Atrial Fibrillation (RESTORE SR)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
Sponsored by
AtriCure, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring AF, Atrial Fibrillation, afib, racing heart, cabg, valve, ablation, bipolar, radiofrequency, rf

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart Center of Indiana
  • University of Michigan
  • Spectrum Health
  • Mayo Clinic
  • Washington University
  • Cleveland Clinic
  • The Methodist Hospital
  • Sentara Norfolk Hospital
  • Sacred Heart Medical Center
  • St. Mary's Hospital Medical Center

Outcomes

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.
The primary safety endpoint is the occurrence of serious adverse events that are considered to be associated with the Maze procedure.

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.
The secondary safety endpoints are: total cross clamp time, total time on bypass, length of hospital stay (days), and length of ICU stay (hours)

Full Information

First Posted
December 3, 2007
Last Updated
January 23, 2012
Sponsor
AtriCure, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00566787
Brief Title
Concomitant Treatment of Permanent Atrial Fibrillation
Acronym
RESTORE SR
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

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AtriCure, Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
AF, Atrial Fibrillation, afib, racing heart, cabg, valve, ablation, bipolar, radiofrequency, rf

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
Intervention Description
Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or Female subject between 18 to 80 years of age 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) Left Ventricular Ejection Fraction ≥ 30% Subject is willing and able to provide written informed consent Subject has a life expectancy of at least 2 years Subject is willing and able to return for scheduled follow-up visits TREATMENT SUBJECTS ONLY: Subject has a 3 month documented history of continuous atrial fibrillation CONTROL SUBJECTS ONLY: Subject is not in atrial fibrillation at time of surgery Exclusion Criteria: Lone AF without indication(s) for concomitant CABG and/or mitral valve surgery, aortic valve surgery, tricuspid valve surgery or double valve surgery Prior cardiac surgery (Redo -including previous ablation) 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 Serum creatinine concentration greater than 2.0 mg/dl Class IV NYHA heart failure symptoms and/or Class IV CCS anginal symptoms Prior history of cerebrovascular accident within 6 months or at any time if there is residual neurologic deficit Active infection Known carotid artery stenosis greater than 80% Severe peripheral arterial occlusive disease defined as claudication with minimal exertion A known drug and/or alcohol addiction Mental impairment or other conditions which may not allow the the subject to understand the nature, significance and scope of the study Pregnancy or desire to get pregnant within 12 months of study enrollment Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A. Marc Gillinov, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49506
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sentara Norfolk Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Sacred Heart Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
99220
Country
United States
Facility Name
St. Mary's Hospital Medical Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

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Concomitant Treatment of Permanent Atrial Fibrillation

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