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

NCT05808907 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2023-04-12

No results posted yet for this study

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

Interventions

OTHER

Questionnaire

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

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Prof. Ran Kornowski, MD FESC FACC · Chairmain of Cardiology devision

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-06
Primary Completion
2024-06-30
Completion
2024-09-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05808907 on ClinicalTrials.gov