Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach



Status:Active, not recruiting
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:2/17/2019
Start Date:February 2015
End Date:December 2025

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Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach for Treatment of Subjects With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation

The objective of this study is to establish the safety and effectiveness of a dual epicardial
and endocardial ablation procedure for patients presenting with Persistent Atrial
Fibrillation or Longstanding Persistent Atrial Fibrillation

The objective of this study is to establish the safety and effectiveness of a dual epicardial
and endocardial ablation procedure for patients presenting with Persistent Atrial
Fibrillation or Longstanding Persistent Atrial Fibrillation utilizing the AtriCure Bipolar
System and AtriClip® PRO LAA Exclusion System in an endoscopic or open ablation procedure,
followed by an endocardial mapping and ablation procedure utilizing commercially available RF
based, irrigated, power controlled, ablation catheters for endocardial lesions. The
endocardial procedure will be staged to occur after 90 days post epicardial surgical
procedure.

Inclusion Criteria:

1. Symptomatic Persistent Atrial Fibrillation or Longstanding Persistent Atrial
Fibrillation refractory to a minimum of one Class I or Class III AADs.

Exclusion Criteria:

1. AF >10 years.

2. Refractory hypertension, defined as systolic (>150 mm Hg) or diastolic (> 90 mm Hg)
blood pressure that remains uncontrolled despite sustained therapy

3. History of pulmonary hypertension

4. Pulmonary vein stenosis in one or more of the pulmonary veins

5. EP catheter ablation procedure to treat atrial fibrillation within 3 months

6. Undergone prior cardiothoracic surgery, previous thorax trauma which resulted in a
pneumothorax or hemothorax.

7. Sleep apnea, home oxygen therapy, moderate to severe COPD, (FEV1/FVC < 70% predicted)
or patient is considered intolerant to single lung ventilation.

8. NYHA Class IV heart failure.

9. Uncorrected, reversible cause(s) of atrial fibrillation, or is currently being treated
for arrhythmias other than atrial fibrillation (AF) or atrial flutter.

10. Documented history of previous catheter ablation with perforation, history of
pericarditis, pericardial effusion, or tamponade.

11. Structural heart disease requiring surgical treatment (i.e. valve disease requiring
repair or replacement within 12 months following surgical ablation procedure).

12. CAD requiring intervention (either surgical, i.e. CABG, or catheter).

13. Ejection fraction < 30%

14. Measured left atrial diameter > 5.5 cm

15. Stroke/cerebrovascular accident (CVA) within previous six months, carotid artery
stenosis greater than 80%.

16. BMI is >40

17. Thrombus in the left atrium or the left atrial appendage, determined by
echocardiography (either at baseline TTE (or equivalent diagnostic test) or
intraoperative TEE).

18. Blood dyscrasia or clotting disorder (i.e. Idiopathic Thrombocytopenic Purpura [ITP]
or Thrombotic Thrombocytopenic Purpura [TTP]).

19. Contraindication to anticoagulation that in the opinion of the investigator poses
undue risk to the patient from participating in the endocardial EP procedure.

20. Documented thromboembolism within the previous six months prior to signing informed
consent.

21. Has the following atrial myxoma, mural thrombus or mural tumor.

22. A condition or congenital anomaly which prevents required surgical or catheter access.

23. A co-morbid condition that, in the opinion of the investigator, poses undue risk of
general anesthesia or port access cardiac surgery.

24. Currently abusing drugs or alcohol.

25. Currently or has participated in a clinical study in the last 3 months prior to
signing informed consent.

26. A psychological disorder that could interfere with provision of informed consent,
completion of tests, therapy, or follow-up.

27. A condition that, in the opinion of the investigator, may jeopardize the patient's
well-being and/or the soundness of this clinical study.

28. Pre-existing esophageal condition that required (or requires) endoscopic therapy or
surgical treatment.
We found this trial at
11
sites
Los Angeles, California 90048
Principal Investigator: Ali Khoynezhad, MD
Phone: 310-423-3300
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Brussels,
Principal Investigator: Mark La Meir, MD, PhD
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Cincinnati, Ohio
Principal Investigator: J. Michael Smith, MD
Phone: 513-862-2877
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Gainesville, Florida 32610
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Harrisburg, Pennsylvania 17043
Principal Investigator: Mubashir Mumtaz, MD
Phone: 717-782-5904
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Norfolk, Virginia 23507
Principal Investigator: Jonathan Philpott, MD
Phone: 757-388-2425
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Norfolk, VA
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Oakland, California 94609
Principal Investigator: Junaid Khan, MD
Phone: 510-869-8490
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Orlando, Florida 32806
Principal Investigator: Steven Hoff, MD
Phone: (321)841-3706
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Orlando, FL
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Kenneth Ellenbogen, MD
Phone: 804-827-1515
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Saint Helena, California 94574
Principal Investigator: Gansevoort Dunnington, MD
Phone: 707-967-5959
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Saint Helena, CA
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Wausau, Wisconsin 54401
Principal Investigator: John Johnokski, MD
Phone: 715-847-2273
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Wausau, WI
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