Concomitant Treatment of Permanent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00566787
• Other study ID #: CP2003-1
• Status: Completed
• Phase: Phase 3
• First received: December 3, 2007
• Last updated: January 23, 2012
• Start date: January 2005
• Est. completion date: November 2010

Study information

• Verified date: January 2012
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2010
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Cleveland Clinic	Cleveland	Ohio
United States	Spectrum Health	Grand Rapids	Michigan
United States	The Methodist Hospital	Houston	Texas
United States	Heart Center of Indiana	Indianapolis	Indiana
United States	St. Mary's Hospital Medical Center	Madison	Wisconsin
United States	Sentara Norfolk Hospital	Norfolk	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Sacred Heart Medical Center	Seattle	Washington
United States	Washington University	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months	No
Primary	The primary safety endpoint is the occurrence of serious adverse events that are considered to be associated with the Maze procedure.		30 days	Yes
Secondary	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.		6 Months	No
Secondary	The secondary safety endpoints are: total cross clamp time, total time on bypass, length of hospital stay (days), and length of ICU stay (hours)		Discharge	Yes