Sole-Therapy Treatment of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— RESTORE SR II  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00566176
• Other study ID #: CP2005-1
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 30, 2007
• Last updated: February 4, 2013
• Start date: October 2005
• Est. completion date: February 2017

Study information

• Verified date: February 2013
• 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 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: February 2017
• 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 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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Surgical Ablation using the AtriCure Bipolar System
Surgical Ablation using the AtriCure Bipolar System

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio
United States	Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute	Dallas	Texas
United States	Sacred Heart Medical Center Endovascular Research	Eugene	Oregon
United States	University of Oklahoma Cardiac Arrythmia Research Institute	Oklahoma City	Oklahoma
United States	University Community Hospital/Dr. Kiran C. Patel Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	The primary safety endpoint will be determined by assessing the rate of serious adverse events.		Discharge/30 Days	Yes