Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study

Not Applicable

Completed

• Conditions: Longstanding Persistent Atrial Fibrillation; Persistent Atrial Fibrillation

• Registration Number: NCT01246466
• Lead Sponsor: AtriCure, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-11-22
• Study First Posted: 2010-11-23
• Study Start: 2010-12
• Primary Completion: 2012-12
• Study Completion: 2013-11
• Disposition First Submitted: 2014-04-15
• Disposition First Submitted QC: 2014-06-16
• Disposition First Posted: 2014-06-19
• Status Verified: 2016-01
• Results First Submitted: 2020-10-30
• Results First Submitted QC: 2021-03-08
• Last Update Submitted: 2021-03-08
• Results First Posted: 2021-04-01
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer.	Acute MAE within 30 days post procedure or hospital discharge (up to 7 days), whichever is longer.
Absence of Atrial Fibrillation	12 month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Procedure	During index procedure
Overall Serious Device or Procedure Related Adverse Event Rate	12 month follow-up
Absence of Atrial Fibrillation	After the 3 month blanking period through twelve month follow-up.	Absence of atrial fibrillation after the 3 month blanking period through twelve month follow-up based on auto trigger event monitor.
Number of Participants With DC Cardioversion	12 months
Number of Participants With Reintervention to Address Atrial Dysrhythmia	12 months	Number of Participants with Reintervention to Address Atrial Dysrhythmia, through 12 months
Acute Procedure Success	Upon completion of the index procedure, up to ten hours
Improvement in AF	12 months	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)

Trial Locations

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