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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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