Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation

Coronary Artery Disease Clinical Trial

— PRO-TAVI  

Official title:

Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078619
• Other study ID #: NL77915.041.21
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2021
• Est. completion date: August 22, 2028

Study information

• Verified date: November 2022
• Source: UMC Utrecht
• Contact: Michiel Voskuil, MD PhD
• Phone: +31 (0)88 75 561 67
• Email: mvoskuil[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 466
• Est. completion date: August 22, 2028
• Est. primary completion date: November 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Unprotected LM-stenosis or equivalent
• CAD with patent bypass grafts
• Contraindication for DAPT
• Life expectancy < 1 year

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Coronary Artery Disease
• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Procedure:
• No PCI
Omission of PCI of significant coronary artery disease prior to TAVI

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam	Noord-Holland
Netherlands	OLVG	Amsterdam	Noord-Holland
Netherlands	Amphia Ziekenhuis Breda	Breda	Noord-Brabant
Netherlands	Haga Ziekenhuis Den Haag	Den Haag	Zuid-Holland
Netherlands	Catharina Ziekenhuis Eindhoven	Eindhoven	Noord-Brabant
Netherlands	Medisch Spectrum Twente	Enschede	Overijssel
Netherlands	UMC Groningen	Groningen
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden	Friesland
Netherlands	Antonius Ziekenhuis Nieuwegein	Nieuwegein	Utrecht
Netherlands	RadboudUMC	Nijmegen	Gelderland
Netherlands	UMC Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite of all-cause mortality, myocardial infarction, stroke and major bleeding		12 months
Secondary	all-cause mortality		4 months - 12 months - total follow up 5 years
Secondary	myocardial infarction		4 months - 12 months - total follow up 5 years
Secondary	stroke		4 months - 12 months - total follow up 5 years
Secondary	major bleeding		4 months - 12 months - total follow up 5 years
Secondary	minor bleeding		4 months - 12 months - total follow up 5 years
Secondary	urgent and elective revascularization		4 months - 12 months - total follow up 5 years
Secondary	rehospitalization		4 months - 12 months - total follow up 5 years
Secondary	Left ventricular function measured by echocardiography		12 months
Secondary	Cost-effectiveness of omission of PCI using QALYs		4 months - 12 months
Secondary	Cost-effectiveness of omission of PCI using Incremental Cost Effectiveness Ratios		4 months - 12 months
Secondary	Quality of life assessed by Euro Quality of Life 5D Questionnaire	the system produces a 5-digit health status profile to describe quality of life in a descriptive manner. Therefore, no lowest and highest value can be stated.	4 months - 12 months
Secondary	Quality of life assessed by SF-36 Questionnaire	Questionnaire consists of eight sections. Each section is transformed into a 0 - 100 scale. The lower the score the more disability.	4 months - 12 months
Secondary	Anginal status assessed by CCS classification		4 months - 12 months
Secondary	Anginal status assessed by Seattle Angina Questionnaire		4 months - 12 months
Secondary	Anginal status assessed by NYHA classification		4 months - 12 months
Secondary	Acute kidney injury stage 3 and 4		4 months - 12 months
Secondary	Target lesion revascularization		4 months - 12 months
Secondary	Target vessel revascularization		4 months - 12 months