Clinical trial NCT03621709: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Transcatheter Aortic Valve Implantation
Keywords: TAVR
TAVI
Aortic valve stenosis
Lead sponsor: Fundacin Biomedica Galicia Sur
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with severe symptomatic aortic stenosis undergo TAVI using the CoreValve™ Evolut R™ 34 mm will be included

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

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.

Primary outcomes:
measure: Safety: Stroke
timeFrame: 12 months
measure: Efficacy: prosthetic regurgitation at early post TAVI
timeFrame: 12 months
measure: Safety:Incidence of permanent pacemaker implant rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
state: Pontevedra
Study officials:
affiliation: Hospital Álvaro Cunqueiro
name: Victor A Jiménez Díaz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Álvaro Cunqueiro
name: Pablo Jiménez Díaz, MD, MPH
role: STUDY_DIRECTOR
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