Last reviewed · How we verify
NCT05389631
Trifecta and Epic ViV Detailed Insights Into Management Strategies and Outcomes
trial testing no intervention in Aortic Valve Disease in 76 participants. Completed in 21 December 2023.
21 December 2023
Quick facts
| Lead sponsor | Helios Health Institute GmbH |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 76 |
| Start date | 17 August 2022 |
| Primary completion | 21 December 2023 |
| Estimated completion | 21 December 2023 |
| Sites | 5 locations across Belgium, Netherlands, Germany |
Drugs / interventions tested
- no intervention
Conditions studied
- Aortic Valve Disease — all drugs for Aortic Valve Disease →
Sponsor
Helios Health Institute GmbH
Who can join
Eligibility, any sex, with Aortic Valve Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The International Trifecta<sup>TM</sup> and Epic<sup>TM</sup> Valve-in-Valve Registry: Insights Into Clinical & Hemodynamic Outcomes.
Raschpichler M, Abdel-Wahab M, Curzen N, Wilbring M, et al · · 2025 · PMID 40148747 · DOI 10.1002/ccd.31492
Verify or expand the search:
- PubMed search for NCT05389631
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of no intervention
Trials testing the same drug.
- NCT07480057 — Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry · recruiting
- NCT07253506 — Turkish Adaptation, Validity, and Reliability Study of the Patient Experience With Treatment and Self-Management Scale i · not yet recruiting
- NCT07253519 — The Relationship Between Mood and Insomnia Severity and Caregiver Burden in Caregivers of Stroke · not yet recruiting
- NCT07194096 — Stress Hyperglycemia Ratio and Postoperative Delirium · not yet recruiting
- NCT07240337 — Botulinum Toxin Applications in Hemiplegic Patients · recruiting
Other recruiting trials for Aortic Valve Disease
Currently open trials in the same condition.
- NCT07008911 — CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation · NA · recruiting
- NCT07267117 — Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease · recruiting
- NCT07021612 — A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System/ J-Valve System for Pa · recruiting
- NCT06896227 — TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics · NA · recruiting
- NCT06189976 — Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation · NA · recruiting
Other Helios Health Institute GmbH trials
Trials by the same sponsor.
- NCT05203484 — Effect of Multielectrode Versus Point-by-Point Mapping on Recurrence of Ventricular Tachycardia in Ischemic Heart Diseas · NA · suspended
- NCT05133843 — Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Impl · NA · recruiting
- NCT04844931 — Remote Ischemic Conditioning With Local Ischemic Postconditioning in High-Risk ST-elevation Myocardial Infarction · NA · active not recruiting
- NCT04844944 — The Helios Heart Registry: A Standardized Registry for Patients With Specific Cardiac Diseases · recruiting
- NCT05709756 — Prevalence and Predictors of Esophageal Thermal Lesions in High-power-Short-duration Ablation of Atrial Fibrillation · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05389631 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Helios Health Institute GmbH
- Last refreshed: 9 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05389631.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing