TAVI Without Balloon Predilatation (of the Aortic Valve ) SAPIEN 3 (DIRECTAVI)

September 24, 2025 updated by: University Hospital, Montpellier

Implantation of the Transcatheter Aortic Prosthesis SAPIEN 3 With or Without Prior Balloon Predilatation

Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence suggested that aortic valvuloplasty may be harmful and that high success rate may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation and using new generation balloon expandable prothesis is associated with a better net clinical benefit in comparison with procedure performed with pre dilatation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background Transcatheter aortic valve implantation (TAVI) is now the standard of care for inoperable patients with severe symptomatic aortic stenosis and an accepted alternative to surgery for high-risk patients. Despite a high procedure success rate (> 95%), TAVI remained associated with complications directly related to the technique (stroke, aortic regurgitation, vascular access bleeding) or to co morbidities frequently associated with aortic valve disease in elderly and frail patients. Reducing periprocedural complications is thereby the key for the future use of TAVI in lower-risk patients.

Methods/design The transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial is a randomized controlled open label trial that include 240 patients randomized to TAVI performed with prior balloon dilatation of the valve (control arm) or direct implantation of the valve (test arm). The trial tests the hypothesis that the strategy of direct implantation of the balloon expandable SAPIEN 3 prosthesis is non-inferior to current medical practice using predilatation of the valve. The primary endpoint is related to immediate procedural success criteria and secondary end points include complications at 30-day follow-up (VARC 2 criteria). A subgroup analysis evaluates neurological ischemic events with cerebral MRI imaging (25 patients in each strategy group) performed before and after the procedure.

In conclusion, we hope that the study will provide robust evidence of safety and efficiency of TAVI performed without prior dilatation of the aortic valve using the balloon expandable SAPIEN 3 THV and will allow the interventional cardiologist to use this strategy in everyday practice.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • University Hospital of Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Symptomatic Aortic valve stenosis with an aortic valve area <1 cm2 (<0,6 cm3/m2)
  • Males or females of at least 18 years of age
  • Logistic EuroSCORE ≥15% and/or a significant contraindication for open heart surgery (e.g., porcelain aorta or severe COPD) or all patients considered as having excessive surgical risk by the heart team
  • Signed informed consent
  • TAVI performed via transfemoral, sub clavicular or transaortic route with the SAPIEN 3 THV (Edwards Lifescience)

Exclusion Criteria:

  • Transapical TAVI
  • Preexisting aortic prosthesis (valve in valve technique)
  • Vascular conditions that make insertion and endovascular access to the aortic valve impossible
  • BAV performed for less than one week
  • Recent myocardial infarction (STEMI within the last 3 months)
  • Left ventricular or atrial thrombus by echocardiography
  • Mitral or tricuspidal valvular insufficiency (> grade II)
  • Evolutive or recent cerebrovascular event (within the last 3 months)
  • Symptomatic carotid or vertebral arterial narrowing (>70%) disease
  • Bleeding diathesis or coagulopathy or patient refusing blood transfusion
  • Lack of written informed consent, severe mental disorder, drug/alcohol addiction
  • Life expectancy < 1 year
  • Hypersensitivity or contraindication to acetyl salicyl acid, heparin, ticlopidine, clopidogrel, or sensitivity to contrast media that cannot be adequately premedicated
  • Participation in another drug or device study that would jeopardize the appropriate analysis of end-points of this study.
  • High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A
standard procedure TAVI performed with systematic pre dilatation (With prior balloon dilatation)
Procedure: TAVI
standard procedure TAVI performed with systematic pre dilatation (With prior balloon dilatation) (ARM A) ou without pre dilatation (ARM B)
Experimental: Groupe B
standard procedure TAVI performed without pre dilatation (Without prior balloon dilatation)
Procedure: TAVI
standard procedure TAVI performed with systematic pre dilatation (With prior balloon dilatation) (ARM A) ou without pre dilatation (ARM B)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
immediate procedural success
Time Frame: up to 72h
Composite endpoint : absence of immediate procedural mortality AND correct positioning of a single prosthetic heart valve into the proper anatomical location AND intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient<20 mm Hg or peak velocity<3 m/s), AND no moderate or severe prosthetic valve regurgitation.
up to 72h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiovascular event
Time Frame: 1 month
1 month
Complications post-procedure
Time Frame: up to 1 month
VARC-2 criteria : life-threatening/major/minor bleeding, vascular access complications, heart failure, acute kidney failure (RANKIN classification stage 2 or 3), conduction disturbances, stroke, pacemaker implantation, Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
up to 1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
neurological ischemic events
Time Frame: up to 2 days
Ancillary study : subgroup analysis evaluates neurological ischemic events with cerebral MRI imaging (25 patients in each strategy group) performed before and after the procedure.
up to 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Edwards Lifesciences

Investigators

  • Principal Investigator: Florence LECLERCQ, MD,PhD, UH of Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2016

Primary Completion (Actual)

June 29, 2018

Study Completion (Actual)

August 9, 2018

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimated)

April 6, 2016

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 24, 2025

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL15_0392
  • 2015-A01823-46 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aortic Valve Stenosis

Clinical Trials on TAVI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe