NCT05078619Active, not recruiting
Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation
Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation: the PRO-TAVI Trial
Source: ClinicalTrials.gov · Last updated 16 Dec 2024
Brief summary (registry, in English)
The aim of this trial is to evaluate the safety and cost effectiveness of omission of percutaneous coronary intervention of significant coronary artery disease in patients scheduled to undergo transcatheter aortic valve implantation.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 466 (actual)
- First submitted
- 21 Sept 2021
- Start date
- 5 Oct 2021
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- UMC Utrecht
- Diseases
- Coronary artery disease
- NCT number
- NCT05078619
What you commit to
- Study type: Interventional
- Participants enrolled: 466
- From 5 Oct 2021 to the primary completion date, 1 Dec 2025
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Unprotected LM-stenosis or equivalent
- No PCI-eligible stenosis
- Contraindication for DAPT
- Life expectancy \< 1 year
Who the study is looking for
- Severe AoS meeting the criteria stated by the ESC in the ESC/EACTS Guidelines for the management of valvular heart disease AND considered symptomatic (NYHA functional class ≥ 2);
- TAVI decided by multidisciplinary Heart Team taken into account the international standards by ESC and guidelines of Dutch Society for Cardiology (NVVC);
- ≥ 1 stenosis in epicardial coronary artery (\> 2.5mm) or bypass graft. Stenosis is considered significant if angiographic 70-99% or angiographic 40-70% with positive hemodynamic parameters.
- Written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| OLVG Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Amphia Ziekenhuis Breda Coordinator of this site? Confirm its status | Breda | Netherlands | Unknown status |
| Catharina Ziekenhuis Eindhoven Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Unknown status |
| Medisch Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Unknown status |
| UMC Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Medisch Centrum Leeuwarden Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Unknown status |
| Maastricht UMC Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Antonius Ziekenhuis Nieuwegein Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Unknown status |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Haga Ziekenhuis Den Haag Coordinator of this site? Confirm its status | The Hague | Netherlands | Unknown status |
| UMC Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.