Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study

Persistent Atrial Fibrillation Clinical Trial

— DEEP  

Official title:

Feasibility Trial of a Hybrid Approach for Treatment of Patients With Persistent or Longstanding Persistent Atrial Fibrillation With Radiofrequency Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01246466
• Other study ID #: CP2009-1
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: November 2013

Study information

• Verified date: January 2016
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Longstanding Persistent Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• Hybrid: AtriCure Bipolar System & EP ablation procedure
AtriCure Bipolar System plus a catheter ablation

Locations

Country	Name	City	State
United States	UVA	Charlottesville	Virginia
United States	Vanderbilt Heart Institute	Nashville	Tennessee
United States	Sentara Norfolk	Norfolk	Virginia
United States	Baylor Health	Plano	Texas
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint	Acute MAE within 30 days post procedure or hospital discharge (up to 7 days), whichever is longer.	Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer.
Primary	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.	12 month follow-up
Secondary	Overall Serious Device or Procedure Related Adverse Event Rate		12 month follow-up
Secondary	Acute Procedure Success		Upon completion of the index procedure, up to ten hours
Secondary	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.	After the 3 month blanking period through twelve month follow-up.
Secondary	Number of Participants With Reintervention to Address Atrial Dysrhythmia	Number of Participants with Reintervention to Address Atrial Dysrhythmia, through 12 months	12 months
Secondary	Number of Participants With DC Cardioversion		12 months
Secondary	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)	12 months
Secondary	Duration of Procedure		During index procedure