Back to resultsDual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study (DEEP)
Primary Purpose
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hybrid: AtriCure Bipolar System & EP ablation procedure
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation, Ablation, Catheter ablation
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent AF Persistent
- Patient is willing and able to provide written informed consent.
- Patient has a life expectancy of at least 2 years.
- Patient is willing and able to attend the scheduled follow-up visits.
Exclusion Criteria:
- Prior Cardiothoracic Surgery.
- Patient has NYHA Class IV heart failure.
- Evidence of underlying structural heart disease requiring surgical treatment.
- Ejection fraction < 30%
- Measured left atrial diameter > 6.0 cm
- Renal Failure
- Stroke within previous 6 months.
- Known carotid artery stenosis greater than 80%.
- Evidence of significant active infection or endocarditis.
- Pregnant woman or women desiring to become pregnant in the next 24 months.
- Presence of thrombus in the left atrium determined by echocardiography.
- History of blood dyscrasia.
- Contraindication to anticoagulation, based on Investigator's opinion.
- Mural thrombus or tumor.
- Moderate to Severe COPD
Sites / Locations
- Stanford University Medical Center
- Vanderbilt Heart Institute
- Baylor Health
- UVA
- Sentara Norfolk
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AtriCure Bipolar System combined with a catheter ablation
Arm Description
procedure using the AtriCure Bipolar System plus a catheter ablation
Outcomes
Primary Outcome Measures
Primary Safety Endpoint
Acute MAE within 30 days post 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.
Secondary Outcome Measures
Overall Serious Device or Procedure Related Adverse Event Rate
Acute Procedure Success
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.
Number of Participants With Reintervention to Address Atrial Dysrhythmia
Number of Participants with Reintervention to Address Atrial Dysrhythmia, through 12 months
Number of Participants With DC Cardioversion
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)
Duration of Procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01246466
Brief Title
Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study
Acronym
DEEP
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
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (Actual)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AtriCure, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
Keywords
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation, Ablation, Catheter ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AtriCure Bipolar System combined with a catheter ablation
Arm Type
Experimental
Arm Description
procedure using the AtriCure Bipolar System plus a catheter ablation
Intervention Type
Device
Intervention Name(s)
Hybrid: AtriCure Bipolar System & EP ablation procedure
Intervention Description
AtriCure Bipolar System plus a catheter ablation
Primary Outcome Measure Information:
Title
Primary Safety Endpoint
Description
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.
Title
Absence of Atrial Fibrillation
Description
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 Outcome Measure Information:
Title
Overall Serious Device or Procedure Related Adverse Event Rate
Time Frame
12 month follow-up
Title
Acute Procedure Success
Time Frame
Upon completion of the index procedure, up to ten hours
Title
Absence of Atrial Fibrillation
Description
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.
Title
Number of Participants With Reintervention to Address Atrial Dysrhythmia
Description
Number of Participants with Reintervention to Address Atrial Dysrhythmia, through 12 months
Time Frame
12 months
Title
Number of Participants With DC Cardioversion
Time Frame
12 months
Title
Improvement in AF
Description
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
Title
Duration of Procedure
Time Frame
During index procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent AF Persistent
Patient is willing and able to provide written informed consent.
Patient has a life expectancy of at least 2 years.
Patient is willing and able to attend the scheduled follow-up visits.
Exclusion Criteria:
Prior Cardiothoracic Surgery.
Patient has NYHA Class IV heart failure.
Evidence of underlying structural heart disease requiring surgical treatment.
Ejection fraction < 30%
Measured left atrial diameter > 6.0 cm
Renal Failure
Stroke within previous 6 months.
Known carotid artery stenosis greater than 80%.
Evidence of significant active infection or endocarditis.
Pregnant woman or women desiring to become pregnant in the next 24 months.
Presence of thrombus in the left atrium determined by echocardiography.
History of blood dyscrasia.
Contraindication to anticoagulation, based on Investigator's opinion.
Mural thrombus or tumor.
Moderate to Severe COPD
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Vanderbilt Heart Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor Health
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
UVA
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Sentara Norfolk
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study
We'll reach out to this number within 24 hrs