Sole-Therapy Treatment of Atrial Fibrillation

NCT ID: NCT00566176

Last Updated: 2013-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2017-02-28

Brief Summary

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).

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Surgical Ablation using the AtriCure Bipolar System

Surgical Ablation using the AtriCure Bipolar System

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AtriCure, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Warren Jackman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklamhoma Cardiac Arrythmia Research Institute

James Edgerton, MD

Role: PRINCIPAL_INVESTIGATOR

Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute

Locations

University Community Hospital/Dr. Kiran C. Patel Research Institute

Tampa, Florida, United States

University of Cincinnati

Cincinnati, Ohio, United States

University of Oklahoma Cardiac Arrythmia Research Institute

Oklahoma City, Oklahoma, United States

Sacred Heart Medical Center Endovascular Research

Eugene, Oregon, United States

Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute

Dallas, Texas, United States

Countries

United States

Other Identifiers

CP2005-1

Identifier Type: -

Identifier Source: org_study_id