Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency Energy Applications | Procedure | RF energy applications to the atrial edge of a leak resulting from incomplete LAA occlusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Success | Complete LAA occlusion or presence of a mild/minimal peri-device leak on FU TEE | 1-3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Peri-Procedural |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Natale, MD | Contact | 512 544 8186 | dr.natale@gmail.com | |
| Domenico G Della Rocca, MD | Contact | 512 544 8186 | domenicodellarocca@hotmail.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansas City Heart Rhythm Institute | Overland Park | Kansas | 66615 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34330671 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| St. David's Medical Center | Austin | Texas | 78723 | United States |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |