Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study

AtriCure, Inc.24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Persistent Atrial Fibrillation Longstanding Persistent Atrial Fibrillation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

Primary Safety Endpoint

Acute MAE within 30 days post procedure or hospital discharge (up to 7 days), whichever is longer.

Time frame: Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer.

Absence of Atrial Fibrillation

Absence of atrial fibrillation (AF) at twelve month follow-up based on an auto trigger event monitor, while off all Class I and III antiarrhythmic therapy.

Time frame: 12 month follow-up

Secondary Outcomes

Overall Serious Device or Procedure Related Adverse Event Rate

Time frame: 12 month follow-up

Acute Procedure Success

Time frame: Upon completion of the index procedure, up to ten hours

Absence of Atrial Fibrillation

Absence of atrial fibrillation after the 3 month blanking period through twelve month follow-up based on auto trigger event monitor.

Time frame: After the 3 month blanking period through twelve month follow-up.

Number of Participants With Reintervention to Address Atrial Dysrhythmia

Number of Participants with Reintervention to Address Atrial Dysrhythmia, through 12 months

Time frame: 12 months

Number of Participants With DC Cardioversion

Time frame: 12 months

Improvement in AF

Improvement in Atrial Fibrillation Symptom Checklist Frequency (Minimum value: -1.0, Maximum value: 25.0) and Severity Scores (Minimum value: -6.0, Maximum value: 19.0)

Time frame: 12 months

Duration of Procedure

Time frame: During index procedure