Improving quality of life for patients with 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 observational study focuses on patients with severe aortic stenosis, a condition that significantly impacts quality of life due to symptoms like dyspnea and chest pain. It aims to assess the quality of life in these patients using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score. The study includes patients who are symptomatic and have an indication for transcatheter aortic valve implantation (TAVI). The research is crucial as it addresses a growing health concern among the aging population, particularly in Europe and North America.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with symptomatic aortic stenosis (exertional dyspnea, angina, malaise/syncope)

  * Indication for TAVI (valve area 1 cm² or 1 cm²/m² body surface area or mean transvalvular aortic gradient \> 40 mmHg on ultrasound) validated in Heart Team
  * Charlson score ≥ 5
  * Social health care insurance affiliation

Exclusion Criteria:

* Patient refusing TAVI procedure
* CT scan not performed during the pre-TAVI assessment
* Patient unable to understand or answer quality-of-life questionnaires
* Pregnant or breast-feeding women
* Patients participating in other interventional research that may interfere with the present study with an exclusion period still in progress
* Persons under judicial protection
* Patients under guardianship, curators or safeguard of justice

Where it's running

• Service de Cardiologie
  Lyon, France Recruiting
• Service de Cardiologie - CHU Clermont Ferrand
  Clermont-Ferrand, France Not yet recruiting
• Service de Cardiologie
  Lille, France Not yet recruiting
• Service de Cardiologie - Institut Thorax Nantes
  Nantes, France Not yet recruiting

Study contacts

• Study coordinator: Pierre Lantelme, MD
• Email: pierre.lantelme@chu-lyon.fr
• Phone: 04.72.07.25.36

Similar studies

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

• Registry of Transcatheter Aortic Valve Treatments at a Italian Center

  This registry tests how safe and effective transcatheter valve procedures are in adults with severe aortic stenosis treated at a single Italian center.

  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia, Pavia · NCT07596394

• CT-FFR-guided revascularization for people with severe aortic stenosis

  This study will see if adding CT-FFR (a noninvasive blood-flow test) to preoperative CT angiography helps doctors decide whether people with severe aortic stenosis need coronary revascularization before valve replacement.

  Recruiting Yan'an Affiliated Hospital of Kunming Medical University · Kunming, Yunnan · NCT07469371

• RENATUS transcatheter aortic valve for severe aortic stenosis

  This trial tests the RENATUS transcatheter aortic valve in people with symptomatic severe aortic stenosis who are eligible for TAVR.

  Recruiting at 4 sites Beijing Balance Medical Technology Co., Ltd · Beijing and 3 other locations · NCT07414342

• Pre-emptive LAVA-ECMO support for complex, high-risk TAVR

  The team will try pre-emptive left atrial veno-arterial ECMO to stabilize adults with severe aortic stenosis undergoing complex, high-risk TAVR who are unstable or at risk of instability.

  Recruiting at 2 sites Atlantic Health System · Detroit, Michigan and 1 other locations · NCT07309029

• Comparing the DurAVR transcatheter heart valve with SAPIEN and Evolut valves for severe aortic stenosis

  This trial will test whether the DurAVR transcatheter heart valve works as well and is as safe as SAPIEN or Evolut valves in people with severe calcific aortic stenosis, and it also includes a registry for people needing valve‑in‑valve procedures.

  Recruiting Anteris Technologies Ltd. · Copenhagen, Capital Region of Denmark · NCT07194265

• Navitor TAVI valve in Japanese patients with severe aortic stenosis

  This study will try the Navitor transcatheter aortic valve with the FlexNav delivery system in about 100 Japanese adults with symptomatic severe aortic stenosis to track safety and how well the valve works.

  Recruiting at 3 sites Abbott Medical Devices · Fukuoka and 2 other locations · NCT07193888

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.