AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB

Atrial Fibrillation Clinical Trial

— RESTORE SR IIB  

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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00571779
• Other study ID #: CP2007-2
• Status: Withdrawn
• Phase: Phase 2
• First received: December 10, 2007
• Last updated: February 18, 2011

Study information

• Verified date: February 2011
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Feasibility study arm to evaluate the safety of adding the left atrial linear connecting lesions of the Cox-Maze lesion set to the current RESTORE SR II IDE study procedure of performing pulmonary vein isolation, selected left atrial autonomic ganglionated plexi (GP) ablation, and optional left atrial appendage (LAA) excision/exclusion on a beating heart for patients with permanent or persistent Atrial Fibrillation (AF).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patient between 18 and 80 years of age

2. Patient with documented symptomatic persistent or permanent AF and failure or intolerance of one or more Class I or Class III antiarrhythmic drugs.

• Persistent AF: AF that is not self-terminating or is terminated electrically or pharmacologically.

• Longstanding AF: Persistent AF of 12 months (or longer) duration.

• Permanent AF: Longstanding AF in which electrical or pharmacological cardioversion has failed or has not been attempted.

3. Patient is willing and able to provide written informed consent.

4. Patient has a life expectancy of at least 2 years.

5. Patient is willing and able to attend the scheduled follow-up visits.

Exclusion Criteria:

1. Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months.

2. Patients who refuse, but have not failed and can tolerate anti-arrhythmic medications

3. Myocardial infarction within 8 weeks.

4. Prior cardiac surgery.

5. Patient requires cardiac surgery for treatment other than for AF.

6. Class IV NYHA heart failure symptoms, unless due to uncontrolled AF

7. Cerebrovascular accident within previous 6 months

8. Known carotid artery stenosis greater than 80%

9. Evidence of significant active infection

10. Patient unable to undergo TEE

11. Pregnant woman

12. Patient requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia

13. Presence of thrombus in the left atrium

14. Co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery

15. Patient is enrolled in another cardiac clinical trial

16. Left ventricular ejection fraction < 30%

17. Left atrial transverse diameter >6.0

18. Patient has undergone previous thoracic targeted radiation

Study Design

N/A

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• AtriCure Bipolar System

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of performing the operation by demonstrating the ability to consistently isolate the left and right pulmonary veins and to confirm conduction block across the roof, anterior and LAA linear lesions.
Primary	The primary safety endpoint will be determined by assessing the rate of serious adverse events.