Aortic Valve DiseaseNCT05389631
Trifecta and Epic ViV Detailed Insights Into Management Strategies and Outcomes
An observational study of Aortic Valve Disease, run by Helios Health Institute GmbH at 5 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Disease
- How many people
- 76 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 17 Aug 2022to 21 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing VinV TAVI procedures who have previously received a Trifecta or Epic valve in large volume implantation centers until June 2020.
Who may be able to join
- 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.
Who cannot join
- 1. TAVI VinV post-implantation of an aortic valve bioprosthesis other than the Trifecta or Epic valve
- 2. Patients undergoing combined, multiple transcatheter valve procedures in addition to TAVI VinV
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Germany3 sites
Heart Center Dresden University Hospital
Dresden, 01307
University Hospital Jena
Jena, 07747
Heart Center Leipzig University Hospital
Leipzig, 04289
About this study
Official title: The International Trifecta and Epic Valve-in-Valve Registry: Detailed Insights Into Management Strategies and Outcomes
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
Read the detailed description
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.
- Conditions
- Aortic Valve Disease
- Being tested
- no intervention
- Keywords
- VinV TAVI, Trifecta valve, Epic valve
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Trifecta VinV | VinV TAVI procedure in patients who have previously received a Trifecta valve Receives: Other: no intervention | |
| Epic VinV | VinV TAVI procedure in patients who have previously received an Epic valve Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (14)
all-cause mortality
Measured: 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.
Measured: 30-days
freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke
Measured: 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
Measured: 1 year
freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke
Measured: up to 60 months
freedom from each individual Major Adverse Cardiac Event endpoint
Measured: day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier
freedom from each individual Major Adverse Cardiac Event endpoint
Measured: 1 year
freedom from each individual Major Adverse Cardiac Event endpoint
Measured: up to 60 months
freedom from other major Valve Academic Research Consortium 2 (VARC2) complications
Measured: day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier
freedom from other major VARC2 complications
Measured: 1 year
freedom from other major VARC2 complications
Measured: up to 60 months
post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate
Measured: 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
Measured: 1 year
post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start17 Aug 2022
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helios Health Institute GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Michael Borger, MD, PhD, Study chair, Leipzig Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389631
- Sponsor's protocol ID
- 2019-0249 / SH 10702
- Status last verified
- Oct 2024
- First submitted
- 1 Apr 2022
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40148747
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The International Trifecta and Epic Valve-in-Valve Registry: Detailed Insights Into Management Strategies and Outcomes
- ClinicalTrials.gov ID
- NCT05389631
- Acronym / sponsor ID
- 2019-0249 / SH 10702
- Conditions
- Aortic Valve Disease
- Keywords
- VinV TAVI, Trifecta valve, Epic valve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Helios Health Institute GmbHUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trifecta VinV | – | Other: no interventionVinV TAVI procedure in patients who have previously received a Trifecta valve |
| Epic VinV | – | Other: no interventionVinV TAVI procedure in patients who have previously received an Epic valve |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing VinV TAVI procedures who have previously received a Trifecta or Epic valve in large volume implantation centers until June 2020.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 1. TAVI VinV post-implantation of an aortic valve bioprosthesis other than the Trifecta or Epic valve
- 2. Patients undergoing combined, multiple transcatheter valve procedures in addition to TAVI VinV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | Epic VinV, Trifecta VinV |
Primary outcome
composite endpoint of 30-day all-cause mortality and/or unplanned coronary obstruction
Time frame: 30 days
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.
14 secondary outcomes
all-cause mortality
Time frame: 30-days
patients with unplanned coronary obstruction
Time frame: 30-days
freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke
Time frame: 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
Time frame: 1 year
freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke
Time frame: up to 60 months
freedom from each individual Major Adverse Cardiac Event endpoint
Time frame: day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier
freedom from each individual Major Adverse Cardiac Event endpoint
Time frame: 1 year
freedom from each individual Major Adverse Cardiac Event endpoint
Time frame: up to 60 months
freedom from other major Valve Academic Research Consortium 2 (VARC2) complications
Time frame: day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier
freedom from other major VARC2 complications
Time frame: 1 year
freedom from other major VARC2 complications
Time frame: up to 60 months
post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate
Time frame: 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
Time frame: 1 year
post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate
Time frame: up to 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Derived from this study: PubMed 40148747Raschpichler 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Borger, MD, PhD study chair
Leipzig Heart Center
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease, run by Helios Health Institute GmbH at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite endpoint of 30-day all-cause mortality and/or unplanned coronary obstruction (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05389631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.