Brief Title
CoreValve™ Evolut R™ 34 mm System Registry (CoreValve34)
Official Title
Multicenter Ambispective Study of Clinical Outcomes of the CoreValve™Evolut R™ 34mm System: All Comers Post-market Registry
Brief Summary
With the introduction of the CoreValve™ Evolut R™ 34mm (Medtronic™) prosthesis, patients with
severe symptomatic aortic stenosis (AS) and large aortic annulus have become eligible for
transcatheter aortic valve implantation (TAVI). The aim of this study is to detect the number
of TAVI candidates with large aortic annulus, and to evaluate the feasibility, efficacy, and
safety of TAVI using the CoreValve™ Evolut R™ 34mm.
Detailed Description
With the current transcatheter valves available in the market, is possible to cover a wide
range of patients with diverse and complex anatomies. Nevertheless, there is a subgroup of
patient with large aortic annulus (diameter > 27 mm), in whom the implant of a transcatheter
valve is not possible because there is no valve suitable for such as aortic annulus size.
With the introduction of the CoreValveTM EvolutionTM R 34mm, patients with an aorttic annulus
dimension up to 29 mm in diameter have become eligible for TAVI. However, there is a lack of
information regarding the number of patient with AS and this particular anatomy of the aortic
annulus. Italian and Dutch registries have reported a prevalence between 6.5 to 12.3% with
large aortic annulus requiring the previous CoreValveTM 31mm. Yet, there is no reported data
regarding this population of patients in Spain. Also, the clinical use of this larger
prosthesis covers a wider range of aortic rings and may enchance the procedural challenges,
such as a little margin for proper valve placement, more likelihood of interference with
mitral valve function and damage to the cardiac conduction system during the prosthesis
deployment.
So far, no studies regarding clinical experiences with the CoreValveTM EvolutionTM R 34mm
have been published. The scarce information currently available with this new device may be
distant from those found in its daily clinical use in non-selected patients. The results of
this Spanish nationwide registry will help to answer a scientific need of information
regarding acute procedural results and mid
Study Type
Observational
Primary Outcome
Safety: Stroke
Condition
Aortic Valve Stenosis
Study Arms / Comparison Groups
CoreValve™ Evolut R™ 34mm
Description: All consecutive real-world patients with aortic stenosis selected for TAVI as part of routine clinical care, using a CoreValve™ Evolut R™ 34mm during the inclusion period will be entered the registry.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
100
Start Date
August 1, 2017
Completion Date
September 2020
Primary Completion Date
July 2020
Eligibility Criteria
Inclusion Criteria:
- Subjects ≥ 18 years of age.
- Subject accepted participate and signed informed consent.
- Subject with severe symptomatic AS patients selected for TAVI by the Heart Team of
each participating hospital.
- Patients anatomically suitable for the implantation of a CoreValve™ Evolut R™ 34mm
with the approved indications by any feasible and appropriate vascular routes.
- Subject must agree to undergo all follow-up visits
Exclusion Criteria:
- High probability of non-adherence to the follow-up requirements.
- Explicit refusal of participation in the registry.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Victor A Jiménez Díaz, MD, MPH, ,
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT03621709
Organization ID
ACUN-VALV-001
Responsible Party
Sponsor
Study Sponsor
Fundacin Biomedica Galicia Sur
Study Sponsor
Victor A Jiménez Díaz, MD, MPH, Principal Investigator, Hospital Álvaro Cunqueiro
Verification Date
March 2020