N/A
N=90
Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach
Atrial Fibrillation · Persistent or Longstanding Persistent Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02393885 ↗Enrolled (actual)
90
Serious AEs
26.7%
Results posted
Dec 2024
Primary outcome: Primary: Primary Effectiveness Endpoint — 61 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AtriCure, Inc.
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Effectiveness Endpoint |
61 | — |
| PRIMARY Primary Safety Endpoint |
6 | — |
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
Eligibility Criteria
Inclusion Criteria
- Symptomatic Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation refractory to a minimum of one Class I or Class III AADs.
Exclusion Criteria
- 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 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.
- A psychological disorder that could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
- A condition that, in the opinion of the investigator, may jeopardize the patient's well-being and/or the soundness of this clinical study.
- Pre-existing esophageal condition that required (or requires) endoscopic therapy or surgical treatment.
Data sourced from ClinicalTrials.gov (NCT02393885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.