Patient Reported Outcomes (PROMs) in Transcatheter Aortic Valve Implantation (TAVI) Patients

NCT05808907 | Unknown

• 1 other identifier: 453-18-RMC
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The transcatheter Aortic Valve Implantation (TAVI) population with severe aortic stenosis (AS) is characterized by advanced age (most patients are octogenarians) and multiple comorbidities. For elderly patients, improvements in heart failure symptoms, functional status, and quality of life (QOL) maybe as important as longevity or even more. Over the last decade, we observe a change in trend, estimating medical interventions by clinical parameters along with other non-clinical parameters indicating a day-to-day improvement in factors which are more valuable to the patient and their families. This change is based on the understanding that treating a patient's physical symptoms successfully does not necessarily mean improving their QOL. The patient reported outcome measures (PROMs) initiative is focused upon what matters to patients during and following medical interventions. Data on PROMs in TAVI patients is increasing over the years but is still lacking, despite its potential to improve patient's care. In this study, we intend to create a novel self-developed patient-oriented PROM questionnaire specifically for TAVI patients and use it to assess the differences between physician's and patient's perception of a successful TAVI procedure. These discrepancies will form the basis for building a forecast model for a successful TAVI from the patient's perspective.

Conditions

PROM; Patient Reported Outcomes; Transcatheter Aortic Valve Implantation

Keywords

PROM; Patient reported outcomes; Transcatheter Aortic Valve Implantation

Outcome Measures

Primary Outcomes (3)

• Dependent variable (model) - Successful TAVI from the patient perspective.

  In this research our main objective is to define what is a successful TAVI in the patient's perspective. To do so, we will create and validate a new TAVI PROM questionnaire RT-20 (Rabin TAVI 20 questions questionnaire) and use it to assess the differences between physician's and patient's perception of a successful TAVI procedure. These differences will be used to build a model to predict the patient satisfaction with the TAVI procedure. This model will help to aid in the triage of patients suffering from severe AS in an attempt to avoid futile procedures and thus optimize procedural success and/or resources utilization.

  Before the TAVI procedure until 3 months after it.

• The disagreement between the patient and his/her doctor's perception

  For the discrepancy assessment part, the following outcomes will be measured: Primary - The disagreement between the patient and his/her doctor's perception of the patient's health, measured at 3 months FU visit by the Likert scale.

  Before the TAVI procedure until 3 months after it.

• correlation assessment between patient's survival and patient's RT-20 score

  For the correlation assessment between patient's survival and patient's RT-20 score part: Primary outcome - Correlation extent between patient's survival 12 months post TAVI and patient's RT-20 score.

  Before the TAVI procedure until 12months after it.

Secondary Outcomes (1)

• The disagreement between the doctor's perception before and after observing the RT-20 questionnaire.

  Before the TAVI procedure until 3 months after it.

Interventions

Questionnaire OTHER

A novel TAVI PROMs questionnaire will be created by us and used for this study.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Transcatheter Aortic Valve Implantation (TAVI) Patients before and after the procedure

You may qualify if:

• Patients (men and women) who underwent a successful TAVI procedure (defined according to VARC 2) REF
• Patients who agreed to participate in the study and gave their written inform consent.
• Patients who are capable to fulfill the PROMs questionnaires.

You may not qualify if:

• Patients that are not able to give their consent.
• Patients that from any reason are not able to fulfill the PROM's questionnaire.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Prof. Ran Kornowski, MD FESC FACC

  Chairmain of Cardiology devision

  STUDY CHAIR

Central Study Contacts

Ruthie Vizel, M.Sc

CONTACT

+972-3-6969216; ruthievi@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2018
• First Posted: April 12, 2023
• Study Start: September 6, 2018
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 12, 2023

Record last verified: 2023-03

Locations

IL (1)