Myval Global Study of Myval™ THV Series Implanted in Patients With Native Severe Aortic Valve Stenosis.

NCT04703699 · tracked via the Priya Life Science Spain tracker

Sponsor

Meril Life Sciences Pvt. Ltd

Phase

Observational

Started

2020-08-07

Last updated

2024-03-04

Condition(s) studied

Aortic Valve Stenosis

Investigational drug(s) / intervention(s)

Myval Transcatheter Heart Valve Series

Myval Transcatheter Heart Valve Series: Myval™ THV is a newer-generation balloon-expandable THV characterized by a nickel-cobalt alloy frame composed of a single element - hexagon arranged in a hybrid honeycomb fashion.

Study summary

A retrospective, multinational, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve Series in real-world setting.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * All patients of this study must have received Myval™ THV series for treatment of native severe aortic stenosis and completed a minimum of 30-day follow-up. Exclusion Criteria: * No

Primary outcome measure(s)

Safety and Effectiveness as defined by the Valve Academic Research Consortium-3 (VARC-3) — 30 day
It is the composite of following * All-cause mortality * All stroke (disabling and non-disabling) * Life-threatening or disabling bleeding * Acute kidney injury (stage 2 or 3) * Major vascular complications * Moderate or severe prosthetic valve regurgitation * Conduction system disturbances resulting in a new permanent pacemaker implantation

Trial sites (8)

Facility	City	Region	Status
North Estonia Medical center	Tallinn	Estonia	Recruiting
Clinical Institute Saint Ambrogio	Milan	Italy	Recruiting
Amphia Ziekenhui	Breda	North Brabant	Recruiting
University of Gdansk	Gdansk	Bażyńskiego	Recruiting
University Medical Centre Ljubljana	Ljubljana	Slovenia	Recruiting
Hospital Universitario de Gran Canaria Dr. Negrin	Las Palmas de Gran Canaria	Spain	Recruiting
Hospital Cliinico Univertistario de Valladolid	Valladolid	Spain	Recruiting
Kocaeli University School of Medicine	Kocaeli	Turkey (Türkiye)	Recruiting

More Meril Life Sciences Pvt. Ltd. trials in Spain

LANDMARK Trial: a Randomised Controlled Trial of Myval THV Recruiting

Other trials for the same condition

Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation Recruiting

Effect of Fetal Aortic Valvuloplasty on Outcomes Recruiting

Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation Active, not recruiting

LANDMARK Trial: a Randomised Controlled Trial of Myval THV Recruiting

Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04703699 on ClinicalTrials.gov ↗ ← All trials in Spain