Left Atrial Appendage ThrombosisREACTNCT04726943
RF Applications for Residual LAA Leaks
A study testing Radiofrequency Energy Applications in people with Left Atrial Appendage Thrombosis and Stroke, Ischemic, run by Texas Cardiac Arrhythmia Research Foundation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Atrial Appendage Thrombosis, Stroke, Ischemic, Atrial Fibrillation
- What is being tested?
- Radiofrequency Energy Applications
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. David's Medical Center
Austin, Texas, 78723
Domenico G Della Rocca, MD, 512-544-8186, domenicodellarocca@hotmail.it
Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66615
Dhanunjaya Lakkireddy, MD
About this study
Official title: Radiofrequency Energy Applications Targeting Significant Residual Leaks After Left Atrial Appendage Occlusion
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.
Read the 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.
- Being tested
- Radiofrequency Energy Applications
- Keywords
- stroke, atrial fibrillation, left atrial appendage, prevention, leak, radiofrequency
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency Energy ApplicationsProcedure or surgery
RF energy applications to the atrial edge of a leak resulting from incomplete LAA occlusion
| Study group | Role | What they receive |
|---|---|---|
| RF Energy | Experimental | RF delivery targeting the atrial side of a significant residual leak in patients with acute and chronic evidence of incomplete percutaneous LAA occlusion Receives: Procedure: Radiofrequency Energy Applications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success
Complete LAA occlusion or presence of a mild/minimal peri-device leak on FU TEE
Measured: 1-3 months
Secondary outcomes (1)
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
Measured: Peri-Procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Atrial Appendage ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726943
- Sponsor's protocol ID
- TCAI_RFLK01
- Acronym
- REACT
- Status last verified
- Feb 2021
- First submitted
- 19 Jan 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34330671
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Energy Applications Targeting Significant Residual Leaks After Left Atrial Appendage Occlusion
- ClinicalTrials.gov ID
- NCT04726943
- Acronym / sponsor ID
- REACT / TCAI_RFLK01
- Keywords
- stroke, atrial fibrillation, left atrial appendage, prevention, leak, radiofrequency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RF Energy | Experimental | Procedure: Radiofrequency Energy ApplicationsRF delivery targeting the atrial side of a significant residual leak in patients with acute and chronic evidence of incomplete percutaneous LAA occlusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency Energy ApplicationsRF energy applications to the atrial edge of a leak resulting from incomplete LAA occlusion | Procedure or surgery | RF Energy |
Primary outcome
Procedural Success
Time frame: 1-3 months
Complete LAA occlusion or presence of a mild/minimal peri-device leak on FU TEE
1 secondary outcome
Peri-Procedural Success
Time frame: Peri-Procedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Derived from this study: PubMed 34330671Della 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Energy Applications in people with Left Atrial Appendage Thrombosis and Stroke, Ischemic, run by Texas Cardiac Arrhythmia Research Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Natale, MD (512 544 8186, dr.natale@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Success (time frame: 1-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04726943, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.