NCT02729519

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 8, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2018

Completed
Last Updated

September 30, 2025

Status Verified

January 1, 2024

Enrollment Period

2.1 years

First QC Date

March 31, 2016

Last Update Submit

September 24, 2025

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

  • immediate procedural success

    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 Outcomes (2)

  • cardiovascular event

    1 month

  • Complications post-procedure

    up to 1 month

Other Outcomes (1)

  • neurological ischemic events

    up to 2 days

Study Arms (2)

Group A

OTHER

standard procedure TAVI performed with systematic pre dilatation (With prior balloon dilatation)

Procedure: TAVI

Groupe B

EXPERIMENTAL

standard procedure TAVI performed without pre dilatation (Without prior balloon dilatation)

Procedure: TAVI

Interventions

TAVIPROCEDURE

standard procedure TAVI performed with systematic pre dilatation (With prior balloon dilatation) (ARM A) ou without pre dilatation (ARM B)

Group AGroupe B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Montpellier

Montpellier, 34295, France

Location

Related Publications (5)

  • Robert P, Akodad M, Lattuca B, Gandet T, Meunier PA, Macia JC, Schmutz L, Steinecker M, Roubille F, Cayla G, Leclercq F. Balloon predilation or direct valve implantation in TAVI for women: Insights from the DIRECTAVI study. Catheter Cardiovasc Interv. 2024 Jul;104(1):97-104. doi: 10.1002/ccd.31086. Epub 2024 May 19.

    PMID: 38764290DERIVED

  • Jammoul N, Dupasquier V, Akodad M, Meunier PA, Moulis L, Soltani S, Macia JC, Robert P, Schmutz L, Steinecker M, Piot C, Targosz F, Benkemoun H, Lattuca B, Roubille F, Cayla G, Leclercq F. Long-term follow-up of balloon-expandable valves according to the implantation strategy: insight from the DIRECTAVI trial. Am Heart J. 2024 Apr;270:13-22. doi: 10.1016/j.ahj.2024.01.005. Epub 2024 Jan 20.

    PMID: 38253304DERIVED

  • Akodad M, Roubille F, Marin G, Lattuca B, Macia JC, Delseny D, Gandet T, Robert P, Schmutz L, Piot C, Maupas E, Robert G, Targosz F, Albat B, Cayla G, Leclercq F. Myocardial Injury After Balloon Predilatation Versus Direct Transcatheter Aortic Valve Replacement: Insights From the DIRECTAVI Trial. J Am Heart Assoc. 2020 Dec 15;9(24):e018405. doi: 10.1161/JAHA.120.018405. Epub 2020 Dec 10.

    PMID: 33297821DERIVED

  • Leclercq F, Robert P, Akodad M, Macia JC, Gandet T, Delseny D, Chettouh M, Schmutz L, Robert G, Levy G, Targosz F, Maupas E, Roubille F, Marin G, Nagot N, Albat B, Lattuca B, Cayla G. Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement: Results From the DIRECTAVI Trial. JACC Cardiovasc Interv. 2020 Mar 9;13(5):594-602. doi: 10.1016/j.jcin.2019.12.006.

    PMID: 32139216DERIVED

  • Leclercq F, Robert P, Labour J, Lattuca B, Akodad M, Macia JC, Gervasoni R, Roubille F, Gandet T, Schmutz L, Nogue E, Nagot N, Albat B, Cayla G. Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial. Trials. 2017 Jul 4;18(1):303. doi: 10.1186/s13063-017-2036-y.

    PMID: 28676065DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Florence LECLERCQ, MD,PhD

    UH of Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 6, 2016

Study Start

June 8, 2016

Primary Completion

June 29, 2018

Study Completion

August 9, 2018

Last Updated

September 30, 2025

Record last verified: 2024-01

Locations

FR(1)