Act on Quality of Life in Patients With aortIc Stenosis

Launched by HOSPICES CIVILS DE LYON · Jun 26, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Act on Quality of Life in Patients With Aortic Stenosis," is focused on understanding how a new treatment called Transcatheter Aortic Valve Implantation (TAVI) can improve the quality of life for patients suffering from severe aortic stenosis, a condition where the heart's aortic valve becomes narrowed and restricts blood flow. This trial is open to patients aged 65 and older who experience symptoms like shortness of breath, chest pain, or fainting, and who have been approved for the TAVI procedure. Participants will be evaluated based on their overall health and will need to have specific measurements of their heart function confirmed by a medical team.

If you join this trial, you can expect to receive TAVI, a less invasive procedure that replaces the damaged valve without the need for open-heart surgery. You will also be asked to complete questionnaires about your quality of life before and after the procedure, which will help researchers understand the benefits of TAVI. It's important to note that certain individuals, such as those who are pregnant, unable to understand the study questions, or currently involved in other research studies, may not be eligible to participate. Overall, this trial aims to improve care for patients with aortic stenosis and enhance their daily living after treatment.

Gender

ALL

Eligibility criteria

• 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