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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02729519
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : October 11, 2018
Edwards Lifesciences
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date  ICMJE March 31, 2016
First Posted Date  ICMJE April 6, 2016
Last Update Posted Date October 11, 2018
Actual Study Start Date  ICMJE June 8, 2016
Actual Primary Completion Date June 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2016)
  • cardiovascular event [ Time Frame: 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 31, 2016)
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.
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE TAVI Without Balloon Predilatation (of the Aortic Valve ) SAPIEN 3
Official Title  ICMJE Implantation of the Transcatheter Aortic Prosthesis SAPIEN 3 With or Without Prior Balloon Predilatation
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Aortic Valve Stenosis
Intervention  ICMJE Procedure: TAVI
standard procedure TAVI performed with systematic pre dilatation (With prior balloon dilatation) (ARM A) ou without pre dilatation (ARM B)
Study Arms  ICMJE
  • Group A
    standard procedure TAVI performed with systematic pre dilatation (With prior balloon dilatation)
    Intervention: Procedure: TAVI
  • Experimental: Groupe B
    standard procedure TAVI performed without pre dilatation (Without prior balloon dilatation)
    Intervention: Procedure: TAVI
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2018)
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2016)
Actual Study Completion Date  ICMJE August 9, 2018
Actual Primary Completion Date June 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02729519
Other Study ID Numbers  ICMJE 9634
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Edwards Lifesciences
Investigators  ICMJE
Principal Investigator: Florence LECLERCQ, MD,PhD UH of Montpellier
PRS Account University Hospital, Montpellier
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP