- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06043180
Outcome Prediction in Patients With Aortic Stenosis After TAVI (PREDICT-TAVI)
Observational Study of Outcome Prediction in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI) for Severe Symptomatic Aortic Stenosis (PREDICT-TAVI).
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Vitaliy Androshchuk
- Phone Number: 02071881083
- Email: Vitaliy.Androshchuk@gstt.nhs.uk
Study Contact Backup
- Name: Ariella Amar
- Phone Number: 02071887188
Study Locations
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-
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London, United Kingdom
- Guy's & St Thomas' NHS Foundation Trust, St Thomas' Hospital
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Contact:
- Ariella Amar
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Sub-Investigator:
- Vitaliy Androshchuk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Severe aortic stenosis
Aortic valve area <1.0 cm2/<0.6cm2/m2
or mean gradient >40mmHg or jet velocity >4.0 m/s.
|
Intervention on aortic valve for severe aortic stenosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in TAPSE/PASP coupling measure
Time Frame: Baseline to immediately following intervention and 3 months follow up
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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)
Time Frame: Baseline to 3 months follow up
|
Recorded on a wrist-worn accelerometer continuously for 14 days.
|
Baseline to 3 months follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in New York Heart Association (NYHA) Functional Class
Time Frame: Baseline to 3 months follow up
|
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.
|
Baseline to 3 months follow up
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Change in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels)
Time Frame: Baseline to 3 months follow up
|
Biomarker of myocardial strain
|
Baseline to 3 months follow up
|
Change in right ventricular efficiency as measured by ventricular arterial coupling
Time Frame: Baseline to immediately following intervention
|
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.
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Baseline to immediately following intervention
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Change in right ventricular strain/PASP coupling measure
Time Frame: Baseline to immediately following intervention and 3 months follow up
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RV-PA coupling can be measured using ratio of right ventricular strain/PASP on transthoracic echocardiography.
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Baseline to immediately following intervention and 3 months follow up
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Change in right ventricular end-systolic volume/stroke volume coupling measure
Time Frame: Baseline to immediately following intervention and 3 months follow up
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RV-PA coupling can be measured using ratio of right ventricular ESV/SV on transthoracic echocardiography.
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Baseline to immediately following intervention and 3 months follow up
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Change in right ventricular ejection fraction/PASP coupling measure
Time Frame: Baseline to immediately following intervention and 3 months follow up
|
RV-PA coupling can be measured using ratio of right ventricular EF/PASP on transthoracic echocardiography.
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Baseline to immediately following intervention and 3 months follow up
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Change in right ventricular S'/PASP coupling measure
Time Frame: Baseline to immediately following intervention and 3 months follow up
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RV-PA coupling can be measured using ratio of S'/PASP on transthoracic echocardiography.
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Baseline to immediately following intervention and 3 months follow up
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Change in Six Minute Walk Test (6MWT Distance or 6MWD)
Time Frame: Baseline to 3 months follow up
|
The Six Minute Walk Test (6MWT) is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians.
This test measures the distance that a patient can quickly walk ona flat, hard surface in a period of 6 minutes (the 6MWD).
It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation,peripheral circulation, blood, neuromuscular units, and muscle metabolism.
It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing.
The self-paced 6MWT assesses the submaximal level of functional capacity.
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Baseline to 3 months follow up
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Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: Baseline to 3 months follow up
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The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life.
with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms.
The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score.
Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification.
Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
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Baseline to 3 months follow up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Simon Redwood, King's College London
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 319698
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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