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RF Applications for Residual LAA Leaks (REACT)

Primary Purpose

Left Atrial Appendage Thrombosis, Stroke, Ischemic, Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiofrequency Energy Applications
Sponsored by
Texas Cardiac Arrhythmia Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Left Atrial Appendage Thrombosis focused on measuring stroke, atrial fibrillation, left atrial appendage, prevention, leak, radiofrequency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kansas City Heart Rhythm Institute
  • St. David's Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RF Energy

Arm Description

RF delivery targeting the atrial side of a significant residual leak in patients with acute and chronic evidence of incomplete percutaneous LAA occlusion

Outcomes

Primary Outcome Measures

Procedural Success
Complete LAA occlusion or presence of a mild/minimal peri-device leak on FU TEE

Secondary Outcome Measures

Peri-Procedural Success
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

Full Information

First Posted
January 19, 2021
Last Updated
February 8, 2021
Sponsor
Texas Cardiac Arrhythmia Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04726943
Brief Title
RF Applications for Residual LAA Leaks
Acronym
REACT
Official Title
Radiofrequency Energy Applications Targeting Significant Residual Leaks After Left Atrial Appendage Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Cardiac Arrhythmia Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Atrial Appendage Thrombosis, Stroke, Ischemic, Atrial Fibrillation
Keywords
stroke, atrial fibrillation, left atrial appendage, prevention, leak, radiofrequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RF Energy
Arm Type
Experimental
Arm Description
RF delivery targeting the atrial side of a significant residual leak in patients with acute and chronic evidence of incomplete percutaneous LAA occlusion
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency Energy Applications
Intervention Description
RF energy applications to the atrial edge of a leak resulting from incomplete LAA occlusion
Primary Outcome Measure Information:
Title
Procedural Success
Description
Complete LAA occlusion or presence of a mild/minimal peri-device leak on FU TEE
Time Frame
1-3 months
Secondary Outcome Measure Information:
Title
Peri-Procedural Success
Description
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
Time Frame
Peri-Procedural

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Natale, MD
Phone
512 544 8186
Email
dr.natale@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Domenico G Della Rocca, MD
Phone
512 544 8186
Email
domenicodellarocca@hotmail.it
Facility Information:
Facility Name
Kansas City Heart Rhythm Institute
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66615
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dhanunjaya Lakkireddy, MD
Facility Name
St. David's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domenico G Della Rocca, MD
Phone
512-544-8186
Email
domenicodellarocca@hotmail.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34330671
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.
Results Reference
derived

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RF Applications for Residual LAA Leaks

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