Outcome Prediction in Patients With Aortic Stenosis After TAVI

N/ANot Yet RecruitingNCT06043180

Guy's and St Thomas' NHS Foundation Trust69 enrolled

Overview

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

Aortic stenosis (AS), is a condition in which the aortic valve becomes narrowed as people get older, causing the heart pump (the left ventricle) to struggle to push blood through it, leading to breathlessness, chest pain and blackouts. If left untreated, the prognosis is bleak (similar to lung cancer). Previously the only effective treatment for AS was a valve replacement via open heart surgery, which was too high risk for many patients to undergo, meaning they were left without treatment. Over the last decade transcatheter aortic valve implantation (TAVI) has emerged as a treatment option for most patients with severe symptomatic AS. In TAVI, a new valve is inserted through a small tube, usually in the leg artery, which avoids open heart surgery. Clinical outcomes after TAVI have significantly improved with the accumulation of operator and institution experience as well as the wide use of newer generation devices. However, a significant minority of patients undergoing TAVI derive little or no benefit from the procedure. Nearly a third describe no improvement in quality of life, or die within the first year. To combat this problem, it is essential we develop more sophisticated means of predicting adverse outcomes related to TAVI, to improve the selection of patients and identify patients where the potential benefit of the procedure is outweighed by unfavourable outcomes. Assessment of physical recovery and improvement of symptoms and quality of life after TAVI is an important aspect of examining the outcomes of treatment. This is often a more meaningful and relevant treatment goal in the TAVI cohort than 'hard' clinical outcomes (like death and stroke) alone. Traditionally, less emphasis has been put on the assessment of the right side of the heart (the right ventricle) in evaluating physical recovery after TAVI. We propose prospective observational study to evaluate the significance of the right side of the heart on the clinical outcomes related to functional recovery in patients undergoing TAVI.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Stenosis, Severe

Interventions

Transcatheter aortic valve implantationPROCEDURE

Intervention on aortic valve for severe aortic stenosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

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

London, United Kingdom

Outcomes

Primary Outcomes

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

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

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

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

Biomarker of myocardial strain

Time frame: Baseline to 3 months follow up

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

Change in right ventricular strain/PASP coupling measure

Central Contacts

Vitaliy Androshchuk

CONTACT

02071881083 Vitaliy.Androshchuk@gstt.nhs.uk

Ariella Amar

CONTACT

02071887188

Data from ClinicalTrials.gov

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