Phase 2
N=13
Stroke Feasibility Study
Atrial Fibrillation · AFib
Bottom Line
View on ClinicalTrials.gov: NCT01997905 ↗Enrolled (actual)
13
Serious AEs
50.0%
Results posted
Oct 2016
Primary outcome: Primary: Number of Serious Adverse Events Within 30 Days Post-Index Procedure — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AtriClip LAA Exclusion Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AtriCure, Inc.
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Serious Adverse Events Within 30 Days Post-Index Procedure |
— | — |
| PRIMARY Composite Left Atrial Appendage Placement and Exclusion Success |
8 | — |
| SECONDARY Rate of Stroke and Non-CNS Systemic Embolism |
— | — |
| SECONDARY Serious Device or Procedure Related Adverse Event Rate |
— | — |
| SECONDARY Overall Serious Adverse Event Rate |
3; 1; 2; 1; 1 | — |
| SECONDARY Overall Adverse Event Rate |
3; 3; 1; 3; 3; 1 | — |
Summary
This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage. The purpose is for evaluation of Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation who are unable to take Oral Anticoagulants.
Eligibility Criteria
Inclusion Criteria
- Patient is ≥ 18 years and ≤ 80 years of age.
- Patient has electrocardiographically confirmed non-valvular atrial fibrillation (paroxysmal, persistent, or longstanding persistent AF).
- CHADS2 or CHA2DS2VASc score ≥2.
- Patient has medical contraindication to long term anticoagulant therapy (OAC), defined as one or more of the following:
- history of intracranial bleeding (e.g. due to amyloid angiopathy or other condition) which renders patient unsafe for OAC;
- history of gastrointestinal, genitourinary, or respiratory tract bleeding due to permanent condition which renders patient unsafe for OAC;
- HAS-BLED Score ≥ 3.
- Patient is considered an acceptable surgical candidate, including use of general anesthesia.
- Female patients must be of non-child bearing potential, or have a negative pregnancy test within 7 days prior to index procedure.
Exclusion Criteria
- Stroke within 30 days, or TIA within 3 days, respectively, prior to index procedure.
- Documented medical history of any penetrating trauma to thorax, or blunt trauma to thorax which resulted in a left pneumothorax or left hemothorax.
- Myocardial infarction within 60 days prior to index procedure.
- NYHA Class IV heart failure.
- Ejection fraction 2.0 mg/dl (> 152.5 umol/L) and/or need for dialysis.
- Known carotid artery diameter stenosis greater than 80%.
- Patient has symptomatic or high-grade carotid disease (>70% bilaterally).
- Patient unable or unwilling to undergo transesophageal echocardiography (TEE).
- Presence of thrombus in the left atrium or LAA, as determined by baseline TTE or Computed Tomography Angiogram (CTA).
- Documented history of thrombophilic disorder, with diagnosis established via previous objective testing (e.g. familial screening for thrombophilia).
- Moderate to Severe Chronic Obstructive Pulmonary Disease (FEV1 or VC 35.
- Other medical illness or comorbidity that may cause non-compliance with the protocol, confound data interpretation (e.g. severe dementia), or limited life expectancy (i.e. 50mm, based on TEE imaging.
- Presence of thrombus in the left atrium or LAA based on TEE imaging.
Data sourced from ClinicalTrials.gov (NCT01997905). 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.