Health TrialsbyHealthPanel

Outcome Prediction in Patients With Aortic Stenosis After TAVI

ConditionAortic Stenosis, Severe
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuy's and St Thomas' NHS Foundation Trust

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

Consecutive adult patients planned for transcatheter aortic valve implantation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transcatheter aortic valve implantation

    Procedure/Surgery

    Intervention on aortic valve for severe aortic stenosis

Treatment groups

69 Participants
are divided into 1 treatment group
Group A: Severe aortic stenosis1 intervention

Trial outcomes

Primary outcomes

1

Change in TAPSE/PASP coupling measure

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

Time frame
Baseline to immediately following intervention and 3 months follow up
2

Change in daily accelerometer measured activity (steps)

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

Time frame
Baseline to 3 months follow up

Secondary outcomes

1

Change in New York Heart Association (NYHA) Functional Class

The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms Class IV - Severe limitations.

Time frame
Baseline to 3 months follow up
2

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

Biomarker of myocardial strain

Time frame
Baseline to 3 months follow up
3

Change in right ventricular efficiency as measured by ventricular arterial coupling

VA coupling is calculated by the ratio of effective arterial elastance (Ea), a measure of afterload, to LV end systolic elastance (Ees), a relatively load independent measure of LV chamber performance. Both these measures are expressed in mmHg/ml and as continuous variables.

Time frame
Baseline to immediately following intervention
4

Change in right ventricular strain/PASP coupling measure

RV-PA coupling can be measured using ratio of right ventricular strain/PASP on transthoracic echocardiography.

Time frame
Baseline to immediately following intervention and 3 months follow up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guy's and St Thomas' NHS Foundation Trust

Lead sponsor

King's College London

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: