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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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Non-randomized, open label, non-interventional, multicenter registry to describe risk factors, management strategies, and clinical outcomes in patients undergoing Valve in Valve (ViV) transcatheter aortic valve implantation (TAVI) in a previously implanted Trifecta or Epic valve using retrospective registry data from large volume centers
Anonymized pre-, intra-, and postoperative data will be collected from patients undergoing VinV TAVI in a previously implanted Trifecta™ valve, Trifecta™ GT, Epic™ or Epic™ Supra valve from the largest volume implanters of the Trifecta and Epic valve in Europe until June 2020. The data will be analyzed in order to give a comprehensive description of clinical outcomes for Trifecta VinV procedures, to identify preoperative risk factors for coronary obstruction, 30-day and 1-year mortality, and other major complications, and to analyze the effects of patient characteristics and / or protective maneuvers in order to prevent coronary obstruction.
Differences of Trifecta and Epic failed patients will also be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trifecta VinV | VinV TAVI procedure in patients who have previously received a Trifecta valve |
| |
| Epic VinV | VinV TAVI procedure in patients who have previously received an Epic valve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other | no intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| composite endpoint of 30-day all-cause mortality and/or unplanned coronary obstruction | coronary obstruction defined as (1) coronary obstruction resulting in myocardial infarction and/or cardiogenic shock, or (2) coronary obstruction requiring emergent coronary intervention with or without pre-TAVI coronary protection. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| all-cause mortality | 30-days | |
| patients with unplanned coronary obstruction | coronary obstruction defined as (1) coronary obstruction resulting in myocardial infarction and/or cardiogenic shock, or (2) coronary obstruction requiring emergent coronary intervention with or without pre-TAVI coronary protection. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing VinV TAVI procedures who have previously received a Trifecta or Epic valve in large volume implantation centers until June 2020.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Borger, MD, PhD | Leipzig Heart Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | 3000 | Belgium | |||
| Heart Center Dresden University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40148747 | Derived | Raschpichler M, Abdel-Wahab M, Curzen N, Wilbring M, Dubois C, Lam K, Faerber G, Nagel J, Thiele H, Borger MA. The International TrifectaTM and EpicTM Valve-in-Valve Registry: Insights Into Clinical & Hemodynamic Outcomes. Catheter Cardiovasc Interv. 2025 Jun;105(7):1711-1718. doi: 10.1002/ccd.31492. Epub 2025 Mar 27. |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 30-days |
| freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke | day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier |
| freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke | 1 year |
| freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke | up to 60 months |
| freedom from each individual Major Adverse Cardiac Event endpoint | day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier |
| freedom from each individual Major Adverse Cardiac Event endpoint | 1 year |
| freedom from each individual Major Adverse Cardiac Event endpoint | up to 60 months |
| freedom from other major Valve Academic Research Consortium 2 (VARC2) complications | day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier |
| freedom from other major VARC2 complications | 1 year |
| freedom from other major VARC2 complications | up to 60 months |
| post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate | day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier |
| post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate | 1 year |
| post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate | up to 60 months |
| Dresden |
| 01307 |
| Germany |
| University Hospital Jena | Jena | 07747 | Germany |
| Heart Center Leipzig University Hospital | Leipzig | 04289 | Germany |
| Catharina Hospital Eindhoven | Eindhoven | 5623 | Netherlands |