Atrial Fibrillation, Left Atrial Appendage Thrombosis, Stroke, Ischemic
Conditions
Keywords
stroke, atrial fibrillation, left atrial appendage, prevention, leak, radiofrequency
Brief summary
Although the clinical impact of residual left atrial appendage (LAA) leaks still requires confirmation, its patency resulting from incomplete LAA closure may promote blood stagnation and thrombus formation, and increase the risk of thromboembolic events. The main purpose of this trial is to evaluate the safety and efficacy of percutaneous leak closure with radiofrequency energy applications.
Detailed description
Therapies locally targeting the LAA via occlusion, exclusion, or excision have emerged as an alternative and effective approach for stroke prophylaxis in AF patients, especially those with OAC contra-indications. Despite mounting evidence of their safety and efficacy in comparison with standard oral therapy, device-related thrombus and incomplete LAA closure resulting in residual, significant leak may occur, potentially hindering an effective stroke prevention. Radiofrequency energy has been adopted in several settings (e.g., vascular, orthopedic, aesthetic surgery) to achieve thermal-induced tissue retraction.
Interventions
PROCEDURERadiofrequency Energy Applications
RF energy applications to the atrial edge of a leak resulting from incomplete LAA occlusion
Sponsors
Texas Cardiac Arrhythmia Research Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age\> 18 years. 2. Presence of a significant LAA leak acutely or at follow-up. 3. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Exclusion criteria
1. Life expectancy \< 2 years. 2. pregnant, breastfeeding, or unwilling to practice birth control during participation in the study 3. presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | 1-3 months | Complete LAA occlusion or presence of a mild/minimal peri-device leak on FU TEE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peri-Procedural Success | Peri-Procedural | Complete LAA occlusion or presence of mild/minimal (1-2 mm) residual leak assessed via multiplane color Doppler imaging on TEE/ICE at the end of the procedure |
Countries
United States
Contacts
Primary ContactAndrea Natale, MD
Backup ContactDomenico G Della Rocca, MD
Outcome results
None listed