Transfemoral TAVI With or Without Coronary Angiogram in Patients With Severe Aortic Stenosis (PURE TAVI) (PURETAVI)

Rede Optimus Hospitalar

Status

Enrolling

Conditions

Severe Aortic Stenosis

Treatments

Device: Transcatheter aortic valve implantation

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT06898086

RO-240905

Details and patient eligibility

About

This study will be conducted in patients with severe aortic stenosis who are referred for transcatheter aortic valve implantation (TAVI). TAVI is the recommended treatment for severe aortic stenosis. Currently, before undergoing TAVI, most patients undergo a coronary angiography to check whether the coronary arteries are blocked and to assist in appropriate valve sizing. If significant blockages are detected, they are treated before or during TAVI.

However, many patients who undergo TAVI are older and often have additional cardiovascular conditions such as hypertension, diabetes, or obesity. These comorbidities increase the risk of complications related to coronary angiography, including kidney injury from contrast dye, bleeding, and vascular complications at the access site. As such, it remains uncertain whether routine coronary angiography is necessary for all patients undergoing TAVI, particularly those without symptoms suggestive of myocardial ischemia.

This study aims to determine whether a TAVI treatment pathway without prior coronary angiography is non-inferior to the standard pathway that includes routine coronary angiography, with or without revascularization, in patients with severe aortic stenosis who do not have typical angina symptoms (defined as Canadian Cardiovascular Society Class <3). "Non-inferior" means the study seeks to show that omitting routine coronary angiography is at least as effective and safe as the standard approach.

All participants will receive a CE-certified Myval™ balloon-expandable transcatheter heart valve. This device is commercially available and designed to provide accurate positioning and reliable valve function.

This is a multicentre, investigator-initiated clinical study sponsored by Rede Optimus (RO), Alte Steinhauserstrasse 1, 6330 Cham, Switzerland. RO conducts independent research to address unresolved questions in vascular medicine. The study is financially supported by Meril Life Sciences Pvt. Ltd., Bilakhia House, Survey No.135/139, Muktanand Marg, Chala, Vapi 396191, Gujarat, India.

Approximately 620 patients will be enrolled across 20 centres in 7 European countries. The total study duration is expected to be 42 months, with an 18-month enrollment period and 24-month follow-up for each participant.

Full description

Severe aortic stenosis is a progressive and potentially life-threatening condition in which the aortic valve becomes narrowed and obstructs blood flow from the heart. Transcatheter aortic valve implantation (TAVI) has become an established therapy for patients with severe symptomatic aortic stenosis who are not suitable for surgical valve replacement or are at increased surgical risk.

In contemporary practice, many patients undergo routine invasive coronary angiography prior to TAVI to evaluate for obstructive coronary artery disease and perform coronary revascularization when indicated. However, coronary angiography increases exposure to procedural risks, including bleeding, vascular complications, and contrast associated acute kidney injury. These risks are particularly relevant in the elderly population commonly undergoing TAVI, who may have multiple comorbidities. Emerging clinical evidence suggests that routine pre-procedural coronary angiography may not confer significant clinical benefit in all TAVI candidates, especially in those without clear symptoms of myocardial ischemia. In addition, modern transcatheter valve systems, including the balloon-expandable Myval device used in this study, are designed to allow coronary access after implantation if coronary intervention becomes necessary.

The PURE-TAVI study is a multicenter, prospective, randomized, controlled, investigator-initiated trial designed to evaluate whether a management pathway without routine pre-procedural coronary angiography is non-inferior to the standard pathway that includes routine coronary angiography with or without revascularization prior to TAVI. Eligible patients have severe aortic stenosis and are planned for transfemoral TAVI and do not report angina suggestive of high-risk coronary artery disease (Canadian Cardiovascular Society class less than 3). Approximately 620 patients across about 20 sites in Europe will be randomized in a 1:1 ratio to either standard care with routine coronary angiography and revascularization when needed or a selective approach avoiding coronary angiography unless strongly indicated by clinical or imaging findings.

All patients will receive the CE-marked, commercially available Myval transcatheter heart valve system. The trial is open-label. An independent clinical events committee will adjudicate key safety and efficacy endpoints.

The primary objective is to determine whether omission of routine coronary angiography prior to TAVI is non-inferior to the standard invasive diagnostic strategy in terms of major adverse clinical events at 12 months. The composite primary outcome includes all-cause mortality, myocardial infarction, stroke, acute kidney injury, heart failure hospitalization, and major vascular or major bleeding complications. Secondary objectives include assessment of individual clinical endpoints, need for unplanned coronary angiography or revascularization during follow-up, functional status, health-related quality of life, echocardiographic valve performance, and resource utilization.

Participants will be followed at hospital discharge, 6 months, 12 months, and 24 months. The total study duration is approximately 42 months, including an 18-month enrollment period and 24-month follow-up. This Investigator Initiated study is sponsored by Rede Optimus, Switzerland, with funding support from Meril Life Sciences. All procedures and data collection will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki, and applicable regulatory requirements.

This study aims to provide high-quality evidence on whether a simplified pre-TAVI diagnostic strategy avoiding routine invasive coronary angiography is safe and clinically effective. Results may support optimization of pre-TAVI assessment practices, reduce unnecessary invasive procedures and contrast exposure, and potentially streamline care pathways for patients with severe aortic stenosis undergoing TAVI.

Enrollment

620 estimated patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is older than 18 years with severe AS considered for TAVI by a multidisciplinary heart team.
Patient is candidate for transfemoral TAVI as per local standards and current guidelines.
Patient is willing and capable to give written consent to participate to the trial and confirmed to be able to attend the expected follow up visits.

Exclusion criteria

Patient had a coronary angiogram with or without PCI and/or coronary CT and/or CABG within last 5 years.
Left main PCI in the medical history
Patient has CCS of 3 or more.
Patient has left ventricular ejection fraction <30%.
Patients in whom TAVI through femoral access is ad priori not possible based on clinical assessment or medical history
Patient has been treated for acute myocardial infarction within 30 days before randomization.
Patient has a planned open-heart surgery.
Patient has a life expectancy less than 1 year due to other severe non-cardiac disease.
Patient is participating in another clinical study with an investigational product that has not yet completed the follow up period.
Patient has received previous treatment for aortic valve implantation or replacement.
Female patient who is pregnant at the time of inclusion and female patient of childbearing potential

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

620 participants in 2 patient groups

Experimental group

Description:

(omission of coronary angiography prior to or during TAVI, unless suspicion of potentially revascularization-indicating stenosis of the left main stem based on the TAVI-CT);

Treatment:

Device: Transcatheter aortic valve implantation

Control group

Active Comparator group

Description:

(coronary angiography with or without PCI prior to TAVI).

Treatment:

Device: Transcatheter aortic valve implantation