CoreValve™ Evolut R™ 34 mm System Registry (CoreValve34) (TAVI34mm)
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|ClinicalTrials.gov Identifier: NCT03621709|
Recruitment Status : Active, not recruiting
First Posted : August 8, 2018
Last Update Posted : February 15, 2019
|Condition or disease|
|Aortic Valve Stenosis Transcatheter Aortic Valve Implantation|
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|
|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 :||September 2019|
|Estimated Study Completion Date :||September 2019|
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.
- Safety: Stroke [ Time Frame: 12 months ]Stroke (disabling), dichotomous qualitative variable: yes/no
- 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)
- Safety:Incidence of permanent pacemaker implant rate [ Time Frame: 12 months ]Incidence of permanent pacemaker implant rate, dichotomous qualitative variable: yes/no
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
|Hospital Alvaro Cunqueiro|
|Vigo, Pontevedra, Spain, 36312|
|Principal Investigator:||Victor A Jiménez Díaz, MD, MPH||Hospital Álvaro Cunqueiro|
|Study Director:||Pablo Jiménez Díaz, MD, MPH||Hospital Álvaro Cunqueiro|