RF Applications for Residual LAA Leaks
REACT
Radiofrequency Energy Applications Targeting Significant Residual Leaks After Left Atrial Appendage Occlusion
1 other identifier
interventional
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2021
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2021
CompletedFirst Posted
Study publicly available on registry
January 27, 2021
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFebruary 11, 2021
February 1, 2021
1 year
January 19, 2021
February 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Procedural Success
Complete LAA occlusion or presence of a mild/minimal peri-device leak on FU TEE
1-3 months
Secondary Outcomes (1)
Peri-Procedural Success
Peri-Procedural
Study Arms (1)
RF Energy
EXPERIMENTALRF delivery targeting the atrial side of a significant residual leak in patients with acute and chronic evidence of incomplete percutaneous LAA occlusion
Interventions
RF energy applications to the atrial edge of a leak resulting from incomplete LAA occlusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66615, United States
St. David's Medical Center
Austin, Texas, 78723, United States
Related Publications (1)
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.
PMID: 34330671DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Medical Director
Study Record Dates
First Submitted
January 19, 2021
First Posted
January 27, 2021
Study Start
February 1, 2021
Primary Completion
February 1, 2022
Study Completion
December 31, 2022
Last Updated
February 11, 2021
Record last verified: 2021-02