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

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ClinicalTrials.gov Identifier: NCT03621709
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Fundacin Biomedica Galicia Sur

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.

Condition or disease
Aortic Valve Stenosis Transcatheter Aortic Valve Implantation

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
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Ambispective Study of Clinical Outcomes of the CoreValve™Evolut R™ 34mm System: All Comers Post-market Registry
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Safety: Stroke [ Time Frame: 12 months ]
    Stroke (disabling), dichotomous qualitative variable: yes/no

  2. 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)

  3. Safety:Incidence of permanent pacemaker implant rate [ Time Frame: 12 months ]
    Incidence of permanent pacemaker implant rate, dichotomous qualitative variable: yes/no



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621709


Contacts
Contact: Victor A Jiménez Díaz, MD, MPH +34986825564 ext 514564 victor.alfonso.jimenez@sergas.es
Contact: Pablo Juan Salvadores, Pharma, MPH +34986825564 ext 514564 pablo.juan.salvadores@sergas.es

Locations
Spain
Hospital Alvaro Cunqueiro Recruiting
Vigo, Pontevedra, Spain, 36312
Contact: Victor A Jiménez Díaz, MD, MPH    +34986825564 ext 514564    victor.alfonso.jimenez.diaz@sergas.es   
Contact: Pablo Juan Salvadores, Pharma, MPH    +34986825564 ext 514564    pablo.juan.salvadores@sergas.es   
Principal Investigator: Victor A Jiménez Díaz, MD, MPH         
Sub-Investigator: Andrés Iñiguez Romo, MD, PHD         
Sponsors and Collaborators
Fundacin Biomedica Galicia Sur
Investigators
Principal Investigator: Victor A Jiménez Díaz, MD, MPH Hospital Álvaro Cunqueiro
Study Director: Pablo Jiménez Díaz, MD, MPH Hospital Álvaro Cunqueiro

Publications:

Responsible Party: Fundacin Biomedica Galicia Sur
ClinicalTrials.gov Identifier: NCT03621709     History of Changes
Other Study ID Numbers: ACUN-VALV-001
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundacin Biomedica Galicia Sur:
TAVR
TAVI
Aortic valve stenosis

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction