UnknownNot Applicable

RF Applications for Residual LAA Leaks

United States100 participantsStarted 2021-02-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age\> 18 years.
✓. Presence of a significant LAA leak acutely or at follow-up.
✓. 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

✕. Life expectancy \< 2 years.
✕. pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
✕. 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

What they're measuring

Procedural Success

Timeframe: 1-3 months

Trial details

NCT IDNCT04726943

SponsorTexas Cardiac Arrhythmia Research Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-01

Contact for this trial

Andrea Natale, MD

512 544 8186 dr.natale@gmail.com

View on ClinicalTrials.gov More Left Atrial Appendage Thrombosis trials