Hydra THV Transfemoral Valve Implantation in Severe Aortic 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 is an observational registry evaluating transfemoral Hydra THV implantation for severe symptomatic aortic stenosis. The study tracks procedural success, device performance, and early to mid-term clinical outcomes after transcatheter aortic valve replacement. Patients are followed to assess safety and effectiveness in real-world use, using the Hydra THV per its Instructions for Use. Data are collected at participating Spanish centers to understand durability and short-term benefits in routine care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants who meet ALL of the following conditions will be included:

* Age ≥ 18 years and;
* Severe aortic stenosis with indication for aortic valve replacement in which a Hydra THV device is implanted according to the instructions for use; and
* Signed informed consent.

Exclusion Criteria:

Patients who do NOT meet ANY of the following conditions will be included:

* Express refusal by the participant to participate in the study.
* Aortic stenosis patients who are not candidates for Hydra THV device implantation or in whom implantation of this device is performed for an indication other than aortic stenosis (especially pure native aortic valve insufficiency). Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses may be included in the study.
* Participants in randomised clinical trials who have not reached the research endpoint.
* Pregnant and/or breastfeeding women.

Where it's running

• Hospital Clínico San Carlos
  Aravaca, Spain Recruiting
• Hospital de la Santa Creu i Sant Pau
  Barcelona, Spain Recruiting
• Hospital Universitario La Paz
  Fuencarral-El Pardo, Spain Recruiting
• Hospital Universitari de Bellvitge
  L'Hospitalet de Llobregat, Spain Recruiting
• Hospital Universitari de Salamanca
  Salamanca, Spain Recruiting
• Hospital Clínico Universitario de Santiago
  Santiago de Compostela, Spain Recruiting

Study contacts

• Study coordinator: RAUL MORENO GOMEZ, MD, PhD
• Email: raulmorenog@hotmail.com
• Phone: 0034917277000

Similar studies

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

• Using Ticagrelor or Aspirin for Patients After Aortic Valve Implantation

  This study tests whether Ticagrelor works better than Aspirin to prevent blood clots and complications in adults with severe aortic stenosis after they have a heart valve replacement.

  Recruiting Phase 4 Fundacin Biomedica Galicia Sur · Vigo, Pontevedra · NCT05283356

• 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

• 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.