Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study

NCT ID: NCT01246466

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2013-11-30

Brief Summary

The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in treating AF, and how effective this combined procedure is using the AtriCure System in treating AF. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.

Conditions

Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation

Study Design

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

Study Groups

AtriCure Bipolar System combined with a catheter ablation

procedure using the AtriCure Bipolar System plus a catheter ablation

Group Type: EXPERIMENTAL

Hybrid: AtriCure Bipolar System & EP ablation procedure

Intervention Type: DEVICE

AtriCure Bipolar System plus a catheter ablation

Interventions

Hybrid: AtriCure Bipolar System & EP ablation procedure

AtriCure Bipolar System plus a catheter ablation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age > 18 years

2. Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent AF Persistent

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 Cardiothoracic Surgery.

2. Patient has NYHA Class IV heart failure.

3. Evidence of underlying structural heart disease requiring surgical treatment.

4. Ejection fraction < 30%

5. Measured left atrial diameter > 6.0 cm

6. Renal Failure

7. Stroke within previous 6 months.

8. Known carotid artery stenosis greater than 80%.

9. Evidence of significant active infection or endocarditis.

10. Pregnant woman or women desiring to become pregnant in the next 24 months.

11. Presence of thrombus in the left atrium determined by echocardiography.

12. History of blood dyscrasia.

13. Contraindication to anticoagulation, based on Investigator's opinion.

14. Mural thrombus or tumor.

15. Moderate to Severe COPD

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

Sponsors

AtriCure, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanford University Medical Center

Stanford, California, United States

Vanderbilt Heart Institute

Nashville, Tennessee, United States

Baylor Health

Plano, Texas, United States

UVA

Charlottesville, Virginia, United States

Sentara Norfolk

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

CP2009-1

Identifier Type: -

Identifier Source: org_study_id