Sole-Therapy Treatment of Atrial Fibrillation (RESTORE SR II)

Thoracoscopically-Assisted Epicardial Bilateral Pulmonary Vein Isolations Using the AtriCure Bipolar System and Exclusion of the Left Atrial Appendage for the Treatment of Atrial Fibrillation

RESTORE SR II is a feasibility study on the minimally invasive use of the AtriCure Bipolar System for PV Isolation on a beating heart for the treatment of all types of atrial fibrillation in a sole therapy operation (not concomitant to another cardiac operation).

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Surgical Ablation using the AtriCure Bipolar System

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33616
      • University Community Hospital/Dr. Kiran C. Patel Research Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Cardiac Arrythmia Research Institute
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Sacred Heart Medical Center Endovascular Research
  • Texas
    • Dallas, Texas, United States, 75230
      • Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute

Participation Criteria

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 patient between 18 and 80 years of age

2. Patient with symptomatic AF and failure or intolerance of one or more Class I or Class III AADs and:

   • Who describes 3 or more symptomatic AF episodes during the 6 month period prior to enrollment, with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment or,
   • Who has documented AF within the 6 months proceeding enrollment that did not terminate spontaneously (including patients in continuous AF) or,
   • Who is unwilling or unable to take anticoagulants, with 3 or more symptomatic episodes during the 6 month period prior to enrollment with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment.
3. Left Atrial Size < 6 cm (determined by echocardiography performed within 60 days of enrollment), unless the LV dysfunction is thought to result (at least in part) from AF
4. Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography performed within 60 days of enrollment)
5. Patient is willing and able to provide written informed consent.
6. Patient has a life expectancy of at least 2 years.
7. Patient is willing and able to attend the scheduled follow-up visits.
8. Weight < 325 lbs

Exclusion Criteria:

1. Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months
2. Prior cardiac surgery
3. Patients requiring any open heart procedure (e.g. CABG, valve replacement or repair, atrial septal defect repair, etc.)
4. Class IV NYHA heart failure symptoms, unless these symptoms are considered to be due to uncontrolled AF
5. Cerebrovascular accident within previous 6 months
6. Known carotid artery stenosis greater than 80%
7. Evidence of significant active infection
8. Patient unable to undergo TEE
9. Pregnant woman
10. Requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
11. Presence of thrombus in the left atrium
12. Patient has co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery
13. Patient is enrolled in another investigational study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome is the feasibility of performing this operation by demonstrating the ability to consistently isolate the right and left PVs using this minimally invasive approach.	Perioperatively
The primary safety endpoint will be determined by assessing the rate of serious adverse events.	Discharge/30 Days

Collaborators and Investigators

• Sponsor: AtriCure, Inc.
• Investigators: Principal Investigator: Warren Jackman, MD, University of Oklamhoma Cardiac Arrythmia Research Institute; Principal Investigator: James Edgerton, MD, Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): December 1, 2007
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: November 30, 2007
• First Submitted That Met QC Criteria: November 30, 2007
• First Posted (Estimate): December 3, 2007

Study Record Updates

• Last Update Posted (Estimate): February 5, 2013
• Last Update Submitted That Met QC Criteria: February 4, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; AF; pulmonary vein isolation; pvi; AFIB; racing heart; mini maze; maze
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CP2005-1