Aortic Valve StenosisDIRECTAVINCT02729519
TAVI Without Balloon Predilatation (of the Aortic Valve ) SAPIEN 3
A study testing TAVI in people with Aortic Valve Stenosis, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- TAVI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2016to 9 Aug 2018
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- TAVI
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVIProcedure or surgery
standard procedure TAVI performed with systematic pre dilatation (With prior balloon dilatation) (ARM A) ou without pre dilatation (ARM B)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | standard procedure TAVI performed with systematic pre dilatation (With prior balloon dilatation) Receives: Procedure: TAVI |
| Groupe B | Experimental | standard procedure TAVI performed without pre dilatation (Without prior balloon dilatation) Receives: Procedure: TAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 72h
Secondary outcomes (2)
cardiovascular event
Measured: 1 month
Complications post-procedure
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)
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study start8 Jun 2016
- Primary completion29 Jun 2018
- Study completion9 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Florence LECLERCQ, MD,PhD, Principal investigator, UH of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729519
- Sponsor's protocol ID
- RECHMPL15_0392
- Other IDs
- 2015-A01823-46
- Acronym
- DIRECTAVI
- Status last verified
- Jan 2024
- First submitted
- 31 Mar 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 32139216Leclercq 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.
PubMed 28676065Robert 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.
PubMed 38764290Jammoul 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.
PubMed 38253304Akodad 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.
PubMed 33297821