Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial
Abstract Background Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtain...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2017-07-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-2036-y |
| _version_ | 1818151804926427136 |
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| author | Florence Leclercq Pierre Robert Jessica Labour Benoit Lattuca Mariama Akodad Jean-Christophe Macia Richard Gervasoni Francois Roubille Thomas Gandet Laurent Schmutz Erika Nogue Nicolas Nagot Bernard Albat Guillaume Cayla |
| author_facet | Florence Leclercq Pierre Robert Jessica Labour Benoit Lattuca Mariama Akodad Jean-Christophe Macia Richard Gervasoni Francois Roubille Thomas Gandet Laurent Schmutz Erika Nogue Nicolas Nagot Bernard Albat Guillaume Cayla |
| author_sort | Florence Leclercq |
| collection | DOAJ |
| description | Abstract Background Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation of the aortic valve and using new-generation balloon-expandable transcatheter heart valves is associated with a better net clinical benefit than TAVI performed with predilatation. Methods/design The transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial is a randomized controlled open label trial that includes 240 patients randomized to TAVI performed with prior balloon valvuloplasty (control arm) or direct implantation of the valve (test arm). All patients with an indication for TAVI will be included excepting those requiring transapical access. The trial tests the hypothesis that the strategy of direct implantation of the new-generation balloon-expandable SAPIEN 3 valve is noninferior to current medical practice using predilatation of the valve. The primary endpoint assessing efficacy and safety of the procedure consists of immediate procedural success and secondary endpoints 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 between 1 and 3 days after the procedure. Discussion This prospective randomized study is designed to assess the efficacy and safety of TAVI performed without prior dilatation of the aortic valve using new-generation balloon-expandable transcatheter heart valves. We aim to provide robust evidence of the advantages of this strategy to allow the interventional cardiologist to use it in everyday practice. Trial registration ClinicalTrials.gov identifier: NCT02729519 . Registered on 15 July 2016. |
| first_indexed | 2024-12-11T13:44:39Z |
| format | Article |
| id | doaj.art-dfe8e851e16e40fb82b0783526172ecd |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-11T13:44:39Z |
| publishDate | 2017-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-dfe8e851e16e40fb82b0783526172ecd2022-12-22T01:04:35ZengBMCTrials1745-62152017-07-011811910.1186/s13063-017-2036-yPrior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trialFlorence Leclercq0Pierre Robert1Jessica Labour2Benoit Lattuca3Mariama Akodad4Jean-Christophe Macia5Richard Gervasoni6Francois Roubille7Thomas Gandet8Laurent Schmutz9Erika Nogue10Nicolas Nagot11Bernard Albat12Guillaume Cayla13Department of Cardiology, University Hospital of MontpellierDepartment of Cardiology, University Hospital of MontpellierDepartment of Cardiology, University Hospital of MontpellierDepartment of Cardiology, University Hospital of NimesDepartment of Cardiology, University Hospital of MontpellierDepartment of Cardiology, University Hospital of MontpellierDepartment of Cardiology, University Hospital of MontpellierDepartment of Cardiology, University Hospital of MontpellierDepartment of Cardiovascular Surgery, University Hospital of MontpellierDepartment of Cardiology, University Hospital of NimesDepartment of Medical Information, University Hospital of MontpellierDepartment of Medical Information, University Hospital of MontpellierDepartment of Cardiovascular Surgery, University Hospital of MontpellierDepartment of Cardiology, University Hospital of NimesAbstract Background Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation of the aortic valve and using new-generation balloon-expandable transcatheter heart valves is associated with a better net clinical benefit than TAVI performed with predilatation. Methods/design The transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial is a randomized controlled open label trial that includes 240 patients randomized to TAVI performed with prior balloon valvuloplasty (control arm) or direct implantation of the valve (test arm). All patients with an indication for TAVI will be included excepting those requiring transapical access. The trial tests the hypothesis that the strategy of direct implantation of the new-generation balloon-expandable SAPIEN 3 valve is noninferior to current medical practice using predilatation of the valve. The primary endpoint assessing efficacy and safety of the procedure consists of immediate procedural success and secondary endpoints 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 between 1 and 3 days after the procedure. Discussion This prospective randomized study is designed to assess the efficacy and safety of TAVI performed without prior dilatation of the aortic valve using new-generation balloon-expandable transcatheter heart valves. We aim to provide robust evidence of the advantages of this strategy to allow the interventional cardiologist to use it in everyday practice. Trial registration ClinicalTrials.gov identifier: NCT02729519 . Registered on 15 July 2016.http://link.springer.com/article/10.1186/s13063-017-2036-yTranscatheter aortic valve implantation (TAVI)Balloon aortic valvuloplastyProcedural successSafetyRandomized clinical trial |
| spellingShingle | Florence Leclercq Pierre Robert Jessica Labour Benoit Lattuca Mariama Akodad Jean-Christophe Macia Richard Gervasoni Francois Roubille Thomas Gandet Laurent Schmutz Erika Nogue Nicolas Nagot Bernard Albat Guillaume Cayla Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial Trials Transcatheter aortic valve implantation (TAVI) Balloon aortic valvuloplasty Procedural success Safety Randomized clinical trial |
| title | Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial |
| title_full | Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial |
| title_fullStr | Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial |
| title_full_unstemmed | Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial |
| title_short | Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial |
| title_sort | prior balloon valvuloplasty versus direct transcatheter aortic valve implantation directavi study protocol for a randomized controlled trial |
| topic | Transcatheter aortic valve implantation (TAVI) Balloon aortic valvuloplasty Procedural success Safety Randomized clinical trial |
| url | http://link.springer.com/article/10.1186/s13063-017-2036-y |
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