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History of Changes for Study: NCT02393885
Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach (DEEP Pivotal)
Latest version (submitted May 19, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 16, 2015 None (earliest Version on record)
2 April 20, 2015 Study Status and Contacts/Locations
3 May 26, 2015 Contacts/Locations and Study Status
4 June 1, 2015 Study Status and Contacts/Locations
5 June 22, 2015 Contacts/Locations and Study Status
6 December 5, 2015 Contacts/Locations and Study Status
7 January 4, 2016 Study Status and Contacts/Locations
8 February 29, 2016 Study Status and Contacts/Locations
9 April 28, 2016 Contacts/Locations and Study Status
10 November 8, 2016 Recruitment Status, Contacts/Locations and Study Status
11 June 20, 2017 Recruitment Status, Study Status and Contacts/Locations
12 December 1, 2017 Recruitment Status, Study Status and Contacts/Locations
13 December 5, 2017 Contacts/Locations and Study Status
14 December 19, 2017 Contacts/Locations and Study Status
15 February 16, 2018 Contacts/Locations and Study Status
16 April 13, 2018 Recruitment Status, Contacts/Locations and Study Status
17 September 21, 2018 Study Status
18 December 5, 2018 Contacts/Locations, Eligibility, Oversight and Study Status
19 February 11, 2019 Study Status
20 February 28, 2019 Recruitment Status, Contacts/Locations and Study Status
21 March 13, 2019 Contacts/Locations and Study Status
22 March 29, 2019 Contacts/Locations and Study Status
23 April 8, 2019 Contacts/Locations and Study Status
24 May 6, 2019 Contacts/Locations and Study Status
25 June 18, 2019 Contacts/Locations and Study Status
26 August 23, 2019 Contacts/Locations, Study Status and Study Design
27 September 6, 2019 Contacts/Locations and Study Status
28 January 6, 2020 Contacts/Locations and Study Status
29 February 28, 2020 Contacts/Locations and Study Status
30 October 30, 2020 Study Status
31 December 7, 2021 Recruitment Status, Study Status and Contacts/Locations
32 May 19, 2022 Study Status and Study Identification
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Study NCT02393885
Submitted Date:  March 16, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: CP2014-1
Brief Title: Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach (DEEP Pivotal)
Official Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2015
Overall Status: Recruiting
Study Start: February 2015
Primary Completion: September 2018 [Anticipated]
Study Completion: September 2023 [Anticipated]
First Submitted: March 16, 2015
First Submitted that
Met QC Criteria:
March 16, 2015
First Posted: March 20, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 16, 2015
Last Update Posted: March 20, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: AtriCure, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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
Detailed Description: 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.
Open or close this module Conditions
Conditions: Atrial Fibrillation
Persistent or Longstanding Persistent Atrial Fibrillation
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 220 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System
AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System at day 1 of surgical procedure followed by endocardial catheter ablation procedure to occur at approximately 90 days after day 1 of surgical procedure.
Device: AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
Other Names:
  • Irrigated Endocardial Catheters
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Freedom from any documented AF, atrial flutter, or atrial tachycardia lasting >30 seconds in duration through the 12 month follow-up visit in the absence of Class I or III AADs (with the exception of previously failed
[ Time Frame: 6 months post the Endocaridal Ablation Procedure through the 12 month follow-up visit ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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 6 months
  6. Undergone prior cardiothoracic surgery, previous thorax trauma which resulted in a pneumothorax or hemothorax.
  7. Sleep apnea, home oxygen therapy, 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 >35.
  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.
Open or close this module Contacts/Locations
Central Contact Person: Shana Zink
Email: szink@atricure.com
Central Contact Backup: Marla Hoelle
Email: mhoelle@atricure.com
Study Officials: Kenneth Ellenbogen, MD
Principal Investigator
VCU
Vigneshwar Kasirajan, MD
Principal Investigator
VCU
Ali Khoynezhad, MD
Principal Investigator
Cedars-Sinai Medical Center
Paul J Wang, MD
Principal Investigator
Stanford University
Locations: United States, Pennsylvania
Pinnacle Health
[Recruiting]
Harrisburg, Pennsylvania, United States, 17104
Contact:Contact: Heather Reigle, RN 717-782-5904 hreigle@pinnaclehealth.org
Contact:Contact: Jennifer Everhart, RN 717-782-5937 jeverhart@pinnaclehealth.org
Contact:Principal Investigator: Mubashir Mumtaz, MD
Contact:Principal Investigator: Michael Link, MD
Contact:Sub-Investigator: Chinmay Patel, MD
Contact:Sub-Investigator: Nancy Radtke, MD
Contact:Sub-Investigator: Michael Smith, MD
Contact:Sub-Investigator: John Zornosa, MD
Contact:Sub-Investigator: Nikhil Jaik, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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