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

Completed · Not applicable

Conditions studied: Atrial Fibrillation, Persistent or Longstanding Persistent Atrial Fibrillation

In brief

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

Key facts

Study ID

NCT02393885

Run by

AtriCure, Inc.

People needed

90

Starts

2015-02-01

Expected to finish

2024-04-17

Last updated by the study team

2024-12-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• AF >10 years.
• Refractory hypertension, defined as systolic (>150 mm Hg) or diastolic (> 90 mm Hg) blood pressure that remains uncontrolled despite sustained therapy
• History of pulmonary hypertension
• Pulmonary vein stenosis in one or more of the pulmonary veins
• EP catheter ablation procedure to treat atrial fibrillation within 3 months
• Undergone prior cardiothoracic surgery, previous thorax trauma which resulted in a pneumothorax or hemothorax.
• Sleep apnea, home oxygen therapy, moderate to severe COPD, (FEV1/FVC < 70% predicted) or patient is considered intolerant to single lung ventilation.
• NYHA Class IV heart failure.
• Uncorrected, reversible cause(s) of atrial fibrillation, or is currently being treated for arrhythmias other than atrial fibrillation (AF) or atrial flutter.
• Documented history of previous catheter ablation with perforation, history of pericarditis, pericardial effusion, or tamponade.
• Structural heart disease requiring surgical treatment (i.e. valve disease requiring repair or replacement within 12 months following surgical ablation procedure).
• CAD requiring intervention (either surgical, i.e. CABG, or catheter).
• Ejection fraction < 30%
• Measured left atrial diameter > 5.5 cm
• Stroke/cerebrovascular accident (CVA) within previous six months, carotid artery stenosis greater than 80%.
• BMI is >40
• Thrombus in the left atrium or the left atrial appendage, determined by echocardiography (either at baseline TTE (or equivalent diagnostic test) or intraoperative TEE).
• Blood dyscrasia or clotting disorder (i.e. Idiopathic Thrombocytopenic Purpura [ITP] or Thrombotic Thrombocytopenic Purpura [TTP]).
• Contraindication to anticoagulation that in the opinion of the investigator poses undue risk to the patient from participating in the endocardial EP procedure.
• Documented thromboembolism within the previous six months prior to signing informed consent.
• Has the following atrial myxoma, mural thrombus or mural tumor.
• A condition or congenital anomaly which prevents required surgical or catheter access.
• A co-morbid condition that, in the opinion of the investigator, poses undue risk of general anesthesia or port access cardiac surgery.
• Currently abusing drugs or alcohol.
• Currently or has participated in a clinical study in the last 3 months prior to signing informed consent.

Where it is running

• Long Beach Memorial Medical Center — Long Beach, California, United States
• Cedars-Sinai Heart Institute — Los Angeles, California, United States
• Alta Bates Sutter Medical Center, East Bay Hospital — Oakland, California, United States
• St. Helena Hospital, Adventist Heart Institute — St. Helena, California, United States
• Stanford University Department of CV medicine — Stanford, California, United States
• Shands at the University of Florida — Gainesville, Florida, United States
• Orlando Heart Institute — Orlando, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, 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
• Pinnacle Health — Harrisburg, Pennsylvania, United States
• Sentara Cardiovascular Research Institute — Norfolk, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Aspirus Research Institute — Wausau, Wisconsin, United States
• Universitair Ziekenhuis Brussel (UZ Brussels) — Brussels, Belgium
• Academic Medical Center (AMC) — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

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