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Completed

NCT Number: NCT05237804

Evaluation of an Intervention to Reduce the Time to Treatment for TAVI Patients

Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI).

Once a diagnosis has been made and the decision to treat these patients has been taken, the procedure (AVR or TAVI) must be performed rapidly given the poor prognosis of the disease without treatment. Studies have shown that on the waiting list, the probability of death and hospitalisation for heart failure increases with time. This delay could also reduce the effectiveness of TAVI, thus affecting the performance of the healthcare system.

In this study, an intervention combining an e-health component (tool intended for patients, families and health professionals in contact with patients), and an organisational component (for TAVI implanting centres) has been designed. The aim of this study is to evaluate the effectiveness of this intervention.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brest University Hospital, Brest, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient over 18 years of age;
  • Aortic stenosis
  • Indication of TAVI
  • Patient affiliated or benefiting from a health insurance scheme
  • Patient having read and understood the information letter and having signed the consent form

Exclusion criteria

  • TAVI indication not retained
  • Patient who are not fluent in French and have no one around them to translate,
  • Patient who do not have access to the Internet (at home or in their immediate environment)
  • Proven pregnant woman (positive urine pregnancy test) or breastfeeding or absence of effective contraception (as defined by the WHO) or postmenopausal woman without confirmation diagnosis obtained (amenorrhea not medically induced for at least 12 months before the initiation visit) ;
  • Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curators
  • History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participating in the protocol or preventing him from giving his informed consent

Treatment and study plan

Patient component

Other

Video, booklet, website

Organisational component

Other

Coronarography, CT-scan, anesthesia...

Primary outcomes

  1. To evaluate the effectiveness of an intervention combining a patient component and an organisational component

    Time frame: Month 6

    Percentage of patients with a TAVI indication with a time to TAVI procedure of less than 2 months

Secondary outcomes

  1. Time to care, in days

    Time frame: Month 6

    The time to care is the number of days between the date of the initial consultation during which a TAVI is proposed and the date of the TAVI procedure

  2. Mortality rate

    Time frame: Months 3 and 6

    The mortality rate will be measured between the initial consultation during which a TAVI is proposed and the TAVI procedure, and in the three months following the procedure

  3. Patients' health-related quality of life

    Time frame: Baseline, Months 3 and 6

    Patients' health-related quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L).

  4. Patient knowledge of the disease and the TAVI procedure

    Time frame: Baseline, Month 3

    Patients' knowledge of the disease and the TAVI procedure will be measured by their score to an ad hoc questionnaire (0: minimum score - 26: maximum score).

  5. Medication compliance

    Time frame: Month 6

    Patient medication compliance will be measured using a questionnaire developed by Girerd et al, with a score going from 0 (lowest compliance) to 6 (maximum compliance).

  6. Patient satisfaction

    Time frame: Month 6

    Patient satisfaction with the care they received and (for the group receiving the patient component) with the patient component of the intervention will be measured using a 0 to 10 Likert scale

  7. Number of visits to the patient section of the website

    Time frame: Month 6

    The number of visits to the website will be assessed through Googleanalytics®

  8. Number of visits to the professional section of the website

    Time frame: Month 6

    The number of visits to the website will be assessed through Googleanalytics®

  9. Acceptability of the intervention for participating centers

    Time frame: Month 6

    The acceptability of the intervention will be assessed through an ad hoc questionnaire addressed to TAVI centers and peripheral hospitals performing the coronary angiography of the pre-TAVI assessment.

  10. Intervention components' dose and fidelity

    Time frame: Month 6

    Number of different activities really performed for each component of the intervention / number of activities planned for each component according to the protocol.

  11. Reached populations

    Time frame: Month 6

    Percentage of target individuals who benefit from activities of each component of the intervention

  12. Intervention components' adaptation

    Time frame: Month 6

    Number of activities performed which have been modified to adapt them to the local context / total number of activities performed. A description of the adaptations performed will be provided.

  13. Incremental cost-effectiveness ratio

    Time frame: Month 6

    The incremental cost-effectiveness ratio will be expressed in cost per quality-adjusted life-year (QALY) gained, derived from the EQ-5D-5L questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Evaluation d'Une Intervention Pour Reduire le Delai de Traitement Des Patients Traites Par TAVI

Acronym: TREAT

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 14, 2022
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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