NCT06043180

Brief Summary

This study will investigate changes right ventricular function and functional recovery metrics after transcatheter aortic valve implantation

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Oct 2023Feb 2027

First Submitted

Initial submission to the registry

May 23, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Expected
Last Updated

September 21, 2023

Status Verified

May 1, 2023

Enrollment Period

2.3 years

First QC Date

May 23, 2023

Last Update Submit

September 12, 2023

Conditions

Aortic Stenosis, Severe

Outcome Measures

Primary Outcomes (2)

  • Change in TAPSE/PASP coupling measure

    RV-PA coupling is measured using ratio of TAPSE/PASP on transthoracic echocardiography.

    Baseline to immediately following intervention and 3 months follow up

  • Change in daily accelerometer measured activity (steps)

    Recorded on a wrist-worn accelerometer continuously for 14 days.

    Baseline to 3 months follow up

Secondary Outcomes (9)

  • Change in New York Heart Association (NYHA) Functional Class

    Baseline to 3 months follow up

  • Change in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels)

    Baseline to 3 months follow up

  • Change in right ventricular efficiency as measured by ventricular arterial coupling

    Baseline to immediately following intervention

  • Change in right ventricular strain/PASP coupling measure

    Baseline to immediately following intervention and 3 months follow up

  • Change in right ventricular end-systolic volume/stroke volume coupling measure

    Baseline to immediately following intervention and 3 months follow up

  • +4 more secondary outcomes

Study Arms (1)

Severe aortic stenosis

Aortic valve area \<1.0 cm2/\<0.6cm2/m2 or mean gradient \>40mmHg or jet velocity \>4.0 m/s.

Procedure: Transcatheter aortic valve implantation

Interventions

Transcatheter aortic valve implantationPROCEDURE

Intervention on aortic valve for severe aortic stenosis

Severe aortic stenosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive adult patients planned for transcatheter aortic valve implantation.

You may qualify if:

  • Patients with symptomatic severe aortic stenosis (AVA \<1.0 cm2/\<0.6cm2/m2 or mean gradient \>40mmHg or jet velocity \>4.0 m/s).

You may not qualify if:

  • Extracardiac limitations of ambulatory exercise, cardiac rehab opt out, non-transfemoral TAVI, haemodynamic instability/cardiogenic shock, LVEF \<40%, poorly controlled AF, severe COPD, primary pulmonary hypertension, evidence of cardiac amyloid, more than moderate concomitant valvular heart disease other than aortic stenosis, previous sternotomy, permanent pacemaker implant, patients enrolled in another study where participation would involve deviation from either protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's & St Thomas' NHS Foundation Trust, St Thomas' Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Simon Redwood

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vitaliy Androshchuk

CONTACT

02071881083Vitaliy.Androshchuk@gstt.nhs.uk

Ariella Amar

CONTACT

02071887188

Study Design

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

Study Record Dates

First Submitted

May 23, 2023

First Posted

September 21, 2023

Study Start

October 1, 2023

Primary Completion

February 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

September 21, 2023

Record last verified: 2023-05

Locations

GB(1)