Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study
DEEP
Feasibility Trial of a Hybrid Approach for Treatment of Patients With Persistent or Longstanding Persistent Atrial Fibrillation With Radiofrequency Ablation
1 other identifier
interventional
24
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2010
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2010
CompletedFirst Posted
Study publicly available on registry
November 23, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
April 1, 2021
CompletedApril 1, 2021
January 1, 2016
2 years
November 22, 2010
October 30, 2020
March 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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 Outcomes (7)
Overall Serious Device or Procedure Related Adverse Event Rate
12 month follow-up
Acute Procedure Success
Upon completion of the index procedure, up to ten hours
Absence of Atrial Fibrillation
After the 3 month blanking period through twelve month follow-up.
Number of Participants With Reintervention to Address Atrial Dysrhythmia
12 months
Number of Participants With DC Cardioversion
12 months
- +2 more secondary outcomes
Study Arms (1)
AtriCure Bipolar System combined with a catheter ablation
EXPERIMENTALprocedure using the AtriCure Bipolar System plus a catheter ablation
Interventions
AtriCure Bipolar System plus a catheter ablation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AtriCure, Inc.lead
Study Sites (5)
Stanford University Medical Center
Stanford, California, 94305, United States
Vanderbilt Heart Institute
Nashville, Tennessee, 37232, United States
Baylor Health
Plano, Texas, 75093, United States
UVA
Charlottesville, Virginia, 22908, United States
Sentara Norfolk
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Clinical Affairs and Biometrics
- Organization
- AtriCure
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2010
First Posted
November 23, 2010
Study Start
December 1, 2010
Primary Completion
December 1, 2012
Study Completion
November 1, 2013
Last Updated
April 1, 2021
Results First Posted
April 1, 2021
Record last verified: 2016-01