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Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation (PRO-TAVI)

Primary Purpose

Valvular Heart Disease, Aortic Valve Stenosis, Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
No PCI
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Valvular Heart Disease focused on measuring Transcatheter aortic valve implantation, Percutaneous coronary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

  • Medisch Centrum LeeuwardenRecruiting
  • RadboudUMCRecruiting
  • Amphia Ziekenhuis BredaRecruiting
  • Catharina Ziekenhuis EindhovenRecruiting
  • Amsterdam UMCRecruiting
  • OLVGRecruiting
  • Medisch Spectrum TwenteRecruiting
  • Antonius Ziekenhuis NieuwegeinRecruiting
  • Haga Ziekenhuis Den HaagRecruiting
  • UMC GroningenRecruiting
  • UMC UtrechtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TAVI only

TAVI with preceding PCI

Arm Description

Patients randomly allocated to this study arm will undergo transcatheter aortic valve implantation without preceding PCI of significant coronary artery disease

Patients randomly allocated to this study arm will undergo transcatheter aortic valve implantation with preceding PCI of significant coronary artery disease which is currently the standard of care.

Outcomes

Primary Outcome Measures

composite of all-cause mortality, myocardial infarction, stroke and major bleeding

Secondary Outcome Measures

all-cause mortality
myocardial infarction
stroke
major bleeding
minor bleeding
urgent and elective revascularization
rehospitalization
Left ventricular function measured by echocardiography
Cost-effectiveness of omission of PCI using QALYs
Cost-effectiveness of omission of PCI using Incremental Cost Effectiveness Ratios
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.
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.
Anginal status assessed by CCS classification
Anginal status assessed by Seattle Angina Questionnaire
Anginal status assessed by NYHA classification
Acute kidney injury stage 3 and 4
Target lesion revascularization
Target vessel revascularization

Full Information

First Posted
September 21, 2021
Last Updated
November 24, 2022
Sponsor
UMC Utrecht
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05078619
Brief Title
Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation
Acronym
PRO-TAVI
Official Title
Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2021 (Actual)
Primary Completion Date
November 5, 2024 (Anticipated)
Study Completion Date
August 22, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Heart Disease, Aortic Valve Stenosis, Coronary Artery Disease
Keywords
Transcatheter aortic valve implantation, Percutaneous coronary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
466 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAVI only
Arm Type
Experimental
Arm Description
Patients randomly allocated to this study arm will undergo transcatheter aortic valve implantation without preceding PCI of significant coronary artery disease
Arm Title
TAVI with preceding PCI
Arm Type
No Intervention
Arm Description
Patients randomly allocated to this study arm will undergo transcatheter aortic valve implantation with preceding PCI of significant coronary artery disease which is currently the standard of care.
Intervention Type
Procedure
Intervention Name(s)
No PCI
Intervention Description
Omission of PCI of significant coronary artery disease prior to TAVI
Primary Outcome Measure Information:
Title
composite of all-cause mortality, myocardial infarction, stroke and major bleeding
Time Frame
12 months
Secondary Outcome Measure Information:
Title
all-cause mortality
Time Frame
4 months - 12 months - total follow up 5 years
Title
myocardial infarction
Time Frame
4 months - 12 months - total follow up 5 years
Title
stroke
Time Frame
4 months - 12 months - total follow up 5 years
Title
major bleeding
Time Frame
4 months - 12 months - total follow up 5 years
Title
minor bleeding
Time Frame
4 months - 12 months - total follow up 5 years
Title
urgent and elective revascularization
Time Frame
4 months - 12 months - total follow up 5 years
Title
rehospitalization
Time Frame
4 months - 12 months - total follow up 5 years
Title
Left ventricular function measured by echocardiography
Time Frame
12 months
Title
Cost-effectiveness of omission of PCI using QALYs
Time Frame
4 months - 12 months
Title
Cost-effectiveness of omission of PCI using Incremental Cost Effectiveness Ratios
Time Frame
4 months - 12 months
Title
Quality of life assessed by Euro Quality of Life 5D Questionnaire
Description
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.
Time Frame
4 months - 12 months
Title
Quality of life assessed by SF-36 Questionnaire
Description
Questionnaire consists of eight sections. Each section is transformed into a 0 - 100 scale. The lower the score the more disability.
Time Frame
4 months - 12 months
Title
Anginal status assessed by CCS classification
Time Frame
4 months - 12 months
Title
Anginal status assessed by Seattle Angina Questionnaire
Time Frame
4 months - 12 months
Title
Anginal status assessed by NYHA classification
Time Frame
4 months - 12 months
Title
Acute kidney injury stage 3 and 4
Time Frame
4 months - 12 months
Title
Target lesion revascularization
Time Frame
4 months - 12 months
Title
Target vessel revascularization
Time Frame
4 months - 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michiel Voskuil, MD PhD
Phone
+31 (0)88 75 561 67
Email
mvoskuil@umcutrecht.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michiel Voskuil, MD PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
State/Province
Friesland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tessel Vossenberg
Facility Name
RadboudUMC
City
Nijmegen
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niels van Royen
Facility Name
Amphia Ziekenhuis Breda
City
Breda
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sander IJsselmuiden
Facility Name
Catharina Ziekenhuis Eindhoven
City
Eindhoven
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pim Tonino
Facility Name
Amsterdam UMC
City
Amsterdam
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronak Delewi
Facility Name
OLVG
City
Amsterdam
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ton Slagboom
Facility Name
Medisch Spectrum Twente
City
Enschede
State/Province
Overijssel
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gert van Houwelingen
Facility Name
Antonius Ziekenhuis Nieuwegein
City
Nieuwegein
State/Province
Utrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jur ten Berg
Facility Name
Haga Ziekenhuis Den Haag
City
Den Haag
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Schotborgh
Facility Name
UMC Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna Wykrzykowska
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3508GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michiel Voskuil, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation

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