NCT05389631

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 17, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

1.3 years

First QC Date

April 1, 2022

Last Update Submit

October 7, 2024

Conditions

Aortic Valve Disease

Keywords

VinV TAVITrifecta valveEpic valve

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (14)

  • all-cause mortality

    30-days

  • patients with unplanned coronary obstruction

    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

  • +9 more secondary outcomes

Study Arms (2)

Trifecta VinV

VinV TAVI procedure in patients who have previously received a Trifecta valve

Other: no intervention

Epic VinV

VinV TAVI procedure in patients who have previously received an Epic valve

Other: no intervention

Interventions

no interventionOTHER

no intervention

Epic VinVTrifecta VinV

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing VinV TAVI procedures who have previously received a Trifecta or Epic valve in large volume implantation centers until June 2020.

You may qualify if:

  • Patients who underwent a TAVI VinV procedure post-Trifecta or Epic implantation
  • Patients who underwent planned or unplanned concomitant percutaneous coronary intervention (PCI) during the index hospital admission will be included, as will those undergoing emergent conventional cardiac surgery.

You may not qualify if:

  • \. TAVI VinV post-implantation of an aortic valve bioprosthesis other than the Trifecta or Epic valve
  • \. Patients undergoing combined, multiple transcatheter valve procedures in addition to TAVI VinV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Heart Center Dresden University Hospital

Dresden, 01307, Germany

Location

University Hospital Jena

Jena, 07747, Germany

Location

Heart Center Leipzig University Hospital

Leipzig, 04289, Germany

Location

Catharina Hospital Eindhoven

Eindhoven, 5623, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 40148747DERIVED

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Michael Borger, MD, PhD

    Leipzig Heart Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2022

First Posted

May 25, 2022

Study Start

August 17, 2022

Primary Completion

December 21, 2023

Study Completion

December 21, 2023

Last Updated

October 9, 2024

Record last verified: 2024-10

Locations

BE(1)DE(3)NL(1)