CoreValve™ Evolut R™ 34 mm System Registry (CoreValve34) (TAVI34mm)

March 17, 2020 updated by: Fundacin Biomedica Galicia Sur

Multicenter Ambispective Study of Clinical Outcomes of the CoreValve™Evolut R™ 34mm System: All Comers Post-market Registry

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Hospital Álvaro Cunqueiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: Stroke
Time Frame: 12 months
Stroke (disabling), dichotomous qualitative variable: yes/no
12 months
Efficacy: prosthetic regurgitation at early post TAVI
Time Frame: 12 months
Percent of subjects with ≤ mild prosthetic regurgitation at early post-implant (mild, Moderate or Severe)
12 months
Safety:Incidence of permanent pacemaker implant rate
Time Frame: 12 months
Incidence of permanent pacemaker implant rate, dichotomous qualitative variable: yes/no
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacin Biomedica Galicia Sur

Investigators

  • Study Director: Pablo Jiménez Díaz, MD, MPH, Hospital Álvaro Cunqueiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

August 3, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

March 19, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACUN-VALV-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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