Observational study of Myval™ heart valves in patients with severe aortic valve stenosis
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.
Meril Life Sciences Pvt. Ltd. · NCT04703699
This study looks at how well the Myval™ heart valves work and their safety for people with severe aortic valve stenosis by checking the health outcomes of patients who received them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Meril Life Sciences Pvt. Ltd. (industry) |
| Locations | 8 sites (Tallinn and 7 other locations) |
| Trial ID | NCT04703699 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with native severe aortic valve stenosis who have received the Myval™ THV series and completed at least 30 days of follow-up.
Not a fit: Patients who have not received the Myval™ THV series or those with other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the Myval™ heart valve's safety and effectiveness, potentially improving treatment outcomes for patients with severe aortic valve stenosis.
How similar studies have performed: Other studies involving transcatheter heart valves have shown promising results, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tallinn and 7 other locations
- 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)
- Hospital Cliinico Univertistario de Valladolid — Valladolid, Spain (RECRUITING)
- Kocaeli University School of Medicine — Kocaeli, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Ashok Thakkar, Ph.D.
- Email: Ashok.Thakkar@merillife.com
- Phone: +91-260-3063880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Valve Stenosis