Clinical trial NCT04726943: RF Applications for Residual LAA Leaks
Official title: Radiofrequency Energy Applications Targeting Significant Residual Leaks After Left Atrial Appendage Occlusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Left Atrial Appendage Thrombosis
Stroke, Ischemic
Atrial Fibrillation
Keywords: stroke
atrial fibrillation
left atrial appendage
prevention
leak
radiofrequency
Lead sponsor: Texas Cardiac Arrhythmia Research Foundation
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Procedural Success
timeFrame: 1-3 months
Secondary outcomes:
measure: Peri-Procedural Success
timeFrame: Peri-Procedural
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
city: Austin
country: United States
facility: St. David's Medical Center
state: Texas
Study officials:
References:
citation: Della Rocca DG, Murtaza G, Di Biase L, Akella K, Krishnan SC, Magnocavallo M, Mohanty S, Gianni C, Trivedi C, Lavalle C, Forleo GB, Natale VN, Tarantino N, Romero J, Gopinathannair R, Patel PJ, Bassiouny M, Del Prete A, Al-Ahmad A, Burkhardt JD, Gallinghouse GJ, Sanchez JE, Doshi SK, Horton RP, Lakkireddy D, Natale A. Radiofrequency Energy Applications Targeting Significant Residual Leaks After Watchman Implantation: A Prospective, Multicenter Experience. JACC Clin Electrophysiol. 2021 Dec;7(12):1573-1584. doi: 10.1016/j.jacep.2021.06.002. Epub 2021 Jul 27.