Observational study of Myval™ heart valves in patients with severe aortic valve stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects retrospective data from at least 200 patients treated with the Myval™ Transcatheter Heart Valve Series for severe aortic valve stenosis across approximately 15 global sites. The study aims to evaluate the safety and effectiveness of the Myval™ THV series by analyzing various clinical outcomes within 30 days post-implantation. Key endpoints include all-cause mortality, stroke rates, bleeding complications, acute kidney injury, and the need for permanent pacemaker implantation. The findings will provide insights into the real-world performance of this treatment option.

Why it matters

Who can join: the full rules

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

Where it's running

• North Estonia Medical center
  Tallinn, Estonia Recruiting
• Clinical Institute Saint Ambrogio
  Milan, Italy Recruiting
• Amphia Ziekenhui
  Breda, North Brabant, Netherlands Recruiting
• University of Gdansk
  Gdansk, Bażyńskiego, Poland Recruiting
• University Medical Centre Ljubljana
  Ljubljana, Slovenia Recruiting
• Hospital Universitario de Gran Canaria Dr. Negrin
  Las Palmas de Gran Canaria, Spain Recruiting

Study contacts

• Study coordinator: Ashok Thakkar, Ph.D.
• Email: Ashok.Thakkar@merillife.com
• Phone: +91-260-3063880

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring

  This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.

  Recruiting American College of Cardiology · Washington D.C., District of Columbia · NCT07908355

• Vericiguat to slow calcific aortic valve narrowing

  This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07715279

• CHATEAU Registry: Real-world outcomes after TAVR

  This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

  Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

• Impact of TAVR on kidney function in people with aortic valve disease

  This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma, RM · NCT07626710

• Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis

  This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.

  Recruiting at 8 sites Fundación EPIC · Aravaca and 7 other locations · NCT07566624

• How the type of sedation affects recovery after TAVR

  This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.

  Recruiting Phase 4 Endeavor Health · Glenview, Illinois · NCT07556523

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.