Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT07193004
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality of Life Improvement After TAVI (QualiTAVI-UK Trial)
Sponsor:
University Hospital Plymouth NHS Trust
Organization:
Study Overview
Official Title:
Quality of Life Improvement After Transcatheter Aortic Valve Implantation (TAVI) in the UK: A Prospective 1-Year Study (QualiTAVI-UK Trial)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QualiTAVI-UK
Brief Summary:
Transcatheter aortic valve implantation (TAVI) has become an important therapeutic intervention for patients with symptomatic severe aortic stenosis (AS) who are at high surgical risk. While the clinical outcomes of TAVI are well established, there is limited data on the long-term quality of life (QoL) following the procedure. This prospective study will assess QoL in patients undergoing TAVI at Derriford Hospital, University Hospitals Plymouth, UK. Investigators will employ the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and Mini-Montreal Cognitive Assessment (Mini-MoCA) to evaluate both physical and mental health outcomes, supplemented by an analysis of life expectancy estimated by a multidisciplinary team (MDT). Data will be collected at referral, pre-procedural, 30 days, and 3 months post-TAVI. This will be the first prospective trial focused on QoL improvement after TAVI, as all previous studies have been retrospective in nature. The study aims to provide comprehensive insights into the QoL improvements after TAVI, which will guide future clinical decision-making in this population.
Detailed Description:
Study Title uality of Life Improvement after Transcatheter Aortic Valve Implantation (TAVI) in the UK: A Prospective 1-Year Study (QualiTAVI-UK trial)
Study Design This is a prospective, single-center study that will be conducted over 1 year at Derriford Hospital, University Hospitals Plymouth, UK.
Study Participants The study will include all patients undergoing TAVI for severe AS during this period.
Eligibility Criteria Inclusion Criteria: Patients who were eligible and accepted for TAVI procedure regardless of the patient's age and informed consent provided by the patient for the TAVI procedure.
Exclusion Criteria: Patients who declined enrollment in this research.
Planned Sample Size More than 100 patients
Follow-up Duration 3 months
Planned Study Period 1 year
Primary Objective This study aims to address the knowledge gap regarding the impact of TAVI on Quality of Life (QoL) Secondary Objective -
Study Design This is a prospective, single-center study that will be conducted over 1 year at Derriford Hospital, University Hospitals Plymouth, UK.
Study Participants The study will include all patients undergoing TAVI for severe AS during this period.
Eligibility Criteria Inclusion Criteria: Patients who were eligible and accepted for TAVI procedure regardless of the patient's age and informed consent provided by the patient for the TAVI procedure.
Exclusion Criteria: Patients who declined enrollment in this research.
Planned Sample Size More than 100 patients
Follow-up Duration 3 months
Planned Study Period 1 year
Primary Objective This study aims to address the knowledge gap regarding the impact of TAVI on Quality of Life (QoL) Secondary Objective -
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: