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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02393885
Other study ID # CP2014-1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 2015
Est. completion date December 2027

Study information

Verified date March 2023
Source AtriCure, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 220
Est. completion date December 2027
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation


Locations

Country Name City State
Belgium Universitair Ziekenhuis Brussel (UZ Brussels) Brussels
Netherlands Academic Medical Center (AMC) Amsterdam
United States Saint Alphonsus Regional Medical Center Boise Idaho
United States The Christ Hospital Cincinnati Ohio
United States Tri Health Hosptial - Good Samaritan and Bethesda North Hospitals Cincinnati Ohio
United States Shands at the University of Florida Gainesville Florida
United States Pinnacle Health Harrisburg Pennsylvania
United States Long Beach Memorial Medical Center Long Beach California
United States Cedars-Sinai Heart Institute Los Angeles California
United States Sentara Cardiovascular Research Institute Norfolk Virginia
United States Alta Bates Sutter Medical Center, East Bay Hospital Oakland California
United States Orlando Heart Institute Orlando Florida
United States Virginia Commonwealth University Richmond Virginia
United States St. Helena Hospital, Adventist Heart Institute Saint Helena California
United States Sarasota Memorial Hospital Sarasota Florida
United States Stanford University Department of CV medicine Stanford California
United States Aspirus Research Institute Wausau Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
AtriCure, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months post the Endocaridal Ablation Procedure through the 12 month follow-up visit
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