Clinical trial NCT06043180: Outcome Prediction in Patients With Aortic Stenosis After TAVI
Official title: Observational Study of Outcome Prediction in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI) for Severe Symptomatic Aortic Stenosis (PREDICT-TAVI).
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aortic Stenosis, Severe
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2023-09-21
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adult patients planned for transcatheter aortic valve implantation.

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in TAPSE/PASP coupling measure
timeFrame: Baseline to immediately following intervention and 3 months follow up
measure: Change in daily accelerometer measured activity (steps)
timeFrame: Baseline to 3 months follow up
Secondary outcomes:
measure: Change in New York Heart Association (NYHA) Functional Class
timeFrame: Baseline to 3 months follow up
measure: Change in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels)
timeFrame: Baseline to 3 months follow up
measure: Change in right ventricular efficiency as measured by ventricular arterial coupling
timeFrame: Baseline to immediately following intervention
measure: Change in right ventricular strain/PASP coupling measure
timeFrame: Baseline to immediately following intervention and 3 months follow up
measure: Change in right ventricular end-systolic volume/stroke volume coupling measure
timeFrame: Baseline to immediately following intervention and 3 months follow up
measure: Change in right ventricular ejection fraction/PASP coupling measure
timeFrame: Baseline to immediately following intervention and 3 months follow up
measure: Change in right ventricular S'/PASP coupling measure
timeFrame: Baseline to immediately following intervention and 3 months follow up
measure: Change in Six Minute Walk Test (6MWT Distance or 6MWD)
timeFrame: Baseline to 3 months follow up
measure: Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Baseline to 3 months follow up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust, St Thomas' Hospital
Study officials:
affiliation: King's College London
name: Simon Redwood
role: PRINCIPAL_INVESTIGATOR
References: