CoreValve™ Evolut R™ 34 mm System Registry (CoreValve34)

NCT ID: NCT03621709

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2020-09-30

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

Conditions

Aortic Valve Stenosis; Transcatheter Aortic Valve Implantation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CoreValve™ Evolut R™ 34mm

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacin Biomedica Galicia Sur

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victor A Jiménez Díaz, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Hospital Álvaro Cunqueiro

Pablo Jiménez Díaz, MD, MPH

Role: STUDY_DIRECTOR

Hospital Álvaro Cunqueiro

Locations

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Countries

Spain

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Other Identifiers

ACUN-VALV-001

Identifier Type: -

Identifier Source: org_study_id