Outcome Prediction in Patients With Aortic Stenosis After TAVI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcatheter aortic valve implantation.
- Who it may be relevant to
- Registry conditions: Aortic Stenosis, Severe. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Observational Study of Outcome Prediction in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI) for Severe Symptomatic Aortic Stenosis (PREDICT-TAVI).
Overview
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.
Interventions
- Procedure Transcatheter aortic valve implantation
Intervention on aortic valve for severe aortic stenosis
Primary outcome measures
- Change in TAPSE/PASP coupling measure [Time frame: Baseline to immediately following intervention and 3 months follow up]
- Change in daily accelerometer measured activity (steps) [Time frame: Baseline to 3 months follow up]
Secondary outcome measures (9)
- Change in New York Heart Association (NYHA) Functional Class [Time frame: Baseline to 3 months follow up]
- Change in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels) [Time frame: Baseline to 3 months follow up]
- Change in right ventricular efficiency as measured by ventricular arterial coupling [Time frame: Baseline to immediately following intervention]
- Change in right ventricular strain/PASP coupling measure [Time frame: Baseline to immediately following intervention and 3 months follow up]
- Change in right ventricular end-systolic volume/stroke volume coupling measure [Time frame: Baseline to immediately following intervention and 3 months follow up]
- Change in right ventricular ejection fraction/PASP coupling measure [Time frame: Baseline to immediately following intervention and 3 months follow up]
- Change in right ventricular S'/PASP coupling measure [Time frame: Baseline to immediately following intervention and 3 months follow up]
- Change in Six Minute Walk Test (6MWT Distance or 6MWD) [Time frame: Baseline to 3 months follow up]
- Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [Time frame: Baseline to 3 months follow up]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Guy's & St Thomas' NHS Foundation Trust, St Thomas' Hospital — London
Identifiers
NCT: NCT06043180 · 319698