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

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ClinicalTrials.gov Identifier: NCT02729519
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Procedure: TAVI Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Implantation of the Transcatheter Aortic Prosthesis SAPIEN 3 With or Without Prior Balloon Predilatation
Actual Study Start Date : June 8, 2016
Actual Primary Completion Date : June 29, 2018
Actual Study Completion Date : August 9, 2018

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Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. cardiovascular event [ Time Frame: 1 month ]
  2. 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)


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729519


Locations
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France
University hospital of Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Edwards Lifesciences
Investigators
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Principal Investigator: Florence LECLERCQ, MD,PhD UH of Montpellier
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02729519    
Other Study ID Numbers: 9634
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction