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REVIVE TAVR is an acronym for the Randomized Evaluation of Valve-In-Valve versus Explantation for failed TAVR. This is a prospective, multicenter, global randomized trial investigating the safety and efficacy of reintervention for transcatheter heart valve (THV) failure by comparing redo-TAVR (TAV-in-TAV) with TAVR surgical explantation (TAVR-explant) in subjects who are suitable for both options in a real-world clinical setting
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVR-explant | Active Comparator | TAVR surgical explantation |
|
| Redo-TAVR | Active Comparator | TAV-in-TAV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVR-explant | Procedure | Surgical explantation of failed THV followed by surgical aortic valve replacement and any other cardiac surgeries deemed necessary. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes | Time to first event of any components of the composite endpoint. | 30 days |
| Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes | Time to first event of any components of the composite endpoint. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Cardiovascular mortality, Valve-related mortality, Non-cardiovascular mortality | 30 days |
| All-cause mortality | Cardiovascular mortality, Valve-related mortality, Non-cardiovascular mortality |
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Inclusion Criteria:
Exclusion Criteria:
Coronary obstruction risk:
- Patients at risk of coronary obstruction may be enrolled into the randomized cohort if the operators determine that redo-TAVR can be safely accomplished with leaflet modification or other coronary protection strategies.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kassandra Lopez | Contact | 202-877-2452 | kassandra.lopez@medstar.net | |
| Jake Sutton | Contact | 202-877-6624 | Joseph.A.Sutton@medstar.net |
| Name | Affiliation | Role |
|---|---|---|
| Ron Waksman, MD | MedStar Health Research Organization | Principal Investigator |
| Toby Rogers, MD | MedStar Health Research Organization | Study Chair |
| Thomas MacGillivray, MD |
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| ID | Term |
|---|---|
| D011475 | Prosthesis Failure |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Subjects deemed eligible for both redo-TAVR and TAVR-explant by the Heart Team for the treatment of failed THV will be randomized on a 1:1 basis to either redo-TAVR or TAVR-explant.
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| Redo-TAVR | Device | Repeat transcatheter aortic valve implantation within a failed THV. |
|
|
| 12 months |
| Stroke | 30 days |
| Stroke | 12 months |
| Rehospitalization for cardiovascular causes | 30 days |
| Rehospitalization for cardiovascular causes | 12 months |
| Reintervention hospital length of stay (days) | 30 days |
| Cardiovascular mortality | Death meeting one of the following criteria:
Valve-related mortality - Death presumed to be related to bioprosthetic valve dysfunction | 30 days |
| Cardiovascular mortality | Death meeting one of the following criteria:
Valve-related mortality - Death presumed to be related to bioprosthetic valve dysfunction | 12 months |
| VARC-3 bleeding | 30 days |
| VARC-3 bleeding | 12 months |
| Vascular and access-related complications | 30 days |
| Vascular and access-related complications | 12 months |
| Cardiac structural complications | 30 days |
| Cardiac structural complications | 12 months |
| Other acute procedural and technical valve-related complications | 30 days |
| Other acute procedural and technical valve-related complications | 12 months |
| Conduction disturbance requiring permanent pacemaker implantation | 30 days |
| Conduction disturbance requiring permanent pacemaker implantation | 12 months |
| Acute kidney injury | 30 days |
| Acute kidney injury | 12 months |
| Myocardial infarction (adapted from 4th Universal, SCAI, and ARC-2 definitions) | 30 days |
| Myocardial infarction (adapted from 4th Universal, SCAI, and ARC-2 definitions) | 12 months |
| Bioprosthetic valve dysfunction (BVD) and failure (BVF) as defined by the Valve Academic Research Consortium (VARC)-3 Criteria. | 30 days |
| Bioprosthetic valve dysfunction (BVD) and failure (BVF) as defined by the Valve Academic Research Consortium (VARC)-3 Criteria. | 12 months |
| Echocardiographic assessment of prosthetic valve performance | 30 days |
| Echocardiographic assessment of prosthetic valve performance | 12 months |
| Change in NYHA class from Baseline | 30 days |
| Change in NYHA class from Baseline | 12 months |
| Change in Quality of life (KCCQ) from Baseline | The KCCQ has a 0-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. | 30 days |
| Change in Quality of life (KCCQ) from Baseline | The KCCQ has a 0-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. | 12 months |
| Technical Success |
| 30 days |
| Device Success (for Redo-TAVR) |
| 30 days |
| Safety Composite Endpoints |
| 30 days |
| Technical Success | Same as above (Technical Success outcome 34) | 12 months |
| Device Success (for Redo-TAVR) | Same as above (Device Success (for Redo-TAVR) outcome 35) | 12 months |
| Safety Composite Endpoints | Same as above (Safety Composite Endpoints outcome 36) | 12 months |
| MedStar Health Research Organization |
| Study Chair |
| Michael Reardon, MD | MedStar Health Research Organization | Study Chair |
| Kalyan Chitturi, DO | MedStar Health Research Organization | Study Chair |