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This clinical trial evaluates the safety and effectiveness of the Medtronic Intrepidâ„¢ Transcatheter Tricuspid Valve Replacement (TTVR) System in symptomatic patients with severe or greater tricuspid regurgitation.
Prospective, global, pre-market, interventional, multi-center, randomized controlled pivotal trial to evaluate the safety and effectiveness of the Medtronic Intrepidâ„¢ Transcatheter Tricuspid Valve Replacement (TTVR) System compared to Edwards EVOQUE TTVR System in symptomatic patients with severe or greater tricuspid regurgitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medtronic Intrepidâ„¢ TTVR | Experimental | Transcatheter tricuspid valve replacement with Medtronic Intrepidâ„¢ TTVR System in patients with severe or greater tricuspid regurgitation. |
|
| Edwards EVOQUE TTVR | Active Comparator | Transcatheter tricuspid valve replacement with Edwards EVOQUE TTVR in patients with severe or greater tricuspid regurgitation. |
|
| Single Arm Registry | Experimental | Transcatheter tricuspid valve replacement with Medtronic Intrepidâ„¢ TTVR System in patients with severe or greater tricuspid regurgitation who are not eligible for randomization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic Intrepidâ„¢ Transcatheter Tricuspid Valve Replacement (TTVR) System | Device | Transcatheter Tricuspid Valve Replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major Adverse Events (MAE) | 30-days post-procedure | |
| Composite Endpoint: All-cause mortality, Heart failure hospitalization, and tricuspid valve reintervention | 1-year post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Tricuspid regurgitation (TR) grade reduction | Total number of patients with at least one grade TR reduction | 6 months post-procedure |
| Change in quality of life (QoL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amber St Martin | Contact | 612-380-5637 | rs.pathfinder@medtronic.com |
| Name | Affiliation | Role |
|---|---|---|
| Vinayak N. Bapat, MD | Minneapolis Heart Institute | Principal Investigator |
| Anita Asgar, MD | Northwestern Medicine Bluhm Cardiovascular Institute | Principal Investigator |
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| Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System | Device | Transcatheter Tricuspid Valve Replacement |
|
KCCQ overall summary score is a patient-reported measure of health status. Scores range from 0 to 100 where higher scores reflect better quality of life
| 6 months post-procedure |
| All-cause mortality | 12 months post-procedure |
| Heart failure hospitalization | 12 months post-procedure |
| New onset conduction disturbance (NOCD) | 30 days post-procedure |
| Total procedure time | Procedure |
| Right ventricle (RV) dysfunction | 12 months post-procedure |
| Nicolas Dumonteil, MD |
| Clinique Pasteur Groupe CardioVasculaire Interventionnel |
| Principal Investigator |
| Azeem Latib, MD | Montefiore Medical Center | Principal Investigator |
| Firas Zahr, MD | Knight Cardiovascular Institute | Principal Investigator |
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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