Clinical trial NCT01246466: Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study
Official title: Feasibility Trial of a Hybrid Approach for Treatment of Patients With Persistent or Longstanding Persistent Atrial Fibrillation With Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Longstanding Persistent Atrial Fibrillation
Keywords: Persistent Atrial Fibrillation
Longstanding Persistent Atrial Fibrillation
Ablation
Catheter ablation
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer.
measure: Absence of Atrial Fibrillation
timeFrame: 12 month follow-up
Secondary outcomes:
measure: Overall Serious Device or Procedure Related Adverse Event Rate
timeFrame: 12 month follow-up
measure: Acute Procedure Success
timeFrame: Upon completion of the index procedure, up to ten hours
measure: Absence of Atrial Fibrillation
timeFrame: After the 3 month blanking period through twelve month follow-up.
measure: Number of Participants With Reintervention to Address Atrial Dysrhythmia
timeFrame: 12 months
measure: Number of Participants With DC Cardioversion
timeFrame: 12 months
measure: Improvement in AF
timeFrame: 12 months
measure: Duration of Procedure
timeFrame: During index procedure
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Nashville
country: United States
facility: Vanderbilt Heart Institute
state: Tennessee
city: Plano
country: United States
facility: Baylor Health
state: Texas
city: Charlottesville
country: United States
facility: UVA
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk
state: Virginia
Study officials:
References: