Aortic Stenosis, SeverePREDICT-TAVINCT06043180
Outcome Prediction in Patients With Aortic Stenosis After TAVI
An observational study of Aortic Stenosis, Severe, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will investigate changes right ventricular function and functional recovery metrics after transcatheter aortic valve implantation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Severe
- What is being tested?
- Transcatheter aortic valve implantation
- Type of treatment
- Surgery or procedure
- How many people
- 69 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2023to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult patients planned for transcatheter aortic valve implantation.
Who may be able to join
- Patients with symptomatic severe aortic stenosis (AVA <1.0 cm2/<0.6cm2/m2 or mean gradient >40mmHg or jet velocity >4.0 m/s).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ariella Amar contact
United Kingdom1 site
Guy's & St Thomas' NHS Foundation Trust, St Thomas' Hospital
London
Ariella Amar
Vitaliy Androshchuk
About this study
Official title: Observational Study of Outcome Prediction in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI) for Severe Symptomatic Aortic Stenosis (PREDICT-TAVI).
This study will investigate changes right ventricular function and functional recovery metrics after transcatheter aortic valve implantation
Read the 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.
- Conditions
- Aortic Stenosis, Severe
- Being tested
- Transcatheter aortic valve implantation
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve implantationProcedure or surgery
Intervention on aortic valve for severe aortic stenosis
| Study group | Role | What they receive |
|---|---|---|
| Severe aortic stenosis | Aortic valve area <1.0 cm2/<0.6cm2/m2 or mean gradient >40mmHg or jet velocity >4.0 m/s. Receives: Procedure: Transcatheter aortic valve implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TAPSE/PASP coupling measure
RV-PA coupling is measured using ratio of TAPSE/PASP on transthoracic echocardiography.
Measured: 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.
Measured: Baseline to 3 months follow up
Secondary outcomes (9)
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.
Measured: Baseline to 3 months follow up
Change in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels)
Biomarker of myocardial strain
Measured: 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.
Measured: Baseline to immediately following intervention
Change in right ventricular strain/PASP coupling measure
RV-PA coupling can be measured using ratio of right ventricular strain/PASP on transthoracic echocardiography.
Measured: Baseline to immediately following intervention and 3 months follow up
Change in right ventricular end-systolic volume/stroke volume coupling measure
RV-PA coupling can be measured using ratio of right ventricular ESV/SV on transthoracic echocardiography.
Measured: Baseline to immediately following intervention and 3 months follow up
Change in right ventricular ejection fraction/PASP coupling measure
RV-PA coupling can be measured using ratio of right ventricular EF/PASP on transthoracic echocardiography.
Measured: Baseline to immediately following intervention and 3 months follow up
Change in right ventricular S'/PASP coupling measure
RV-PA coupling can be measured using ratio of S'/PASP on transthoracic echocardiography.
Measured: Baseline to immediately following intervention and 3 months follow up
Change in Six Minute Walk Test (6MWT Distance or 6MWD)
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.
Measured: Baseline to 3 months follow up
Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
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.
Measured: Baseline to 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis, SevereStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Simon Redwood, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043180
- Sponsor's protocol ID
- 319698
- Acronym
- PREDICT-TAVI
- Status last verified
- May 2023
- First submitted
- 23 May 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Outcome Prediction in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI) for Severe Symptomatic Aortic Stenosis (PREDICT-TAVI).
- ClinicalTrials.gov ID
- NCT06043180
- Acronym / sponsor ID
- PREDICT-TAVI / 319698
- Conditions
- Aortic Stenosis, Severe
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe aortic stenosis | – | Procedure: Transcatheter aortic valve implantationAortic valve area <1.0 cm2/<0.6cm2/m2 or mean gradient >40mmHg or jet velocity >4.0 m/s. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients planned for transcatheter aortic valve implantation.
Key inclusion criteria (1 listed)
- Patients with symptomatic severe aortic stenosis (AVA <1.0 cm2/<0.6cm2/m2 or mean gradient >40mmHg or jet velocity >4.0 m/s).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter aortic valve implantationIntervention on aortic valve for severe aortic stenosis | Procedure or surgery | Severe aortic stenosis |
Primary outcome
Change in TAPSE/PASP coupling measure
Time frame: Baseline to immediately following intervention and 3 months follow up
RV-PA coupling is measured using ratio of TAPSE/PASP on transthoracic echocardiography.
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ariella Amar contact
Simon Redwood principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, Severe, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vitaliy Androshchuk (02071881083, Vitaliy.Androshchuk@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TAPSE/PASP coupling measure (time frame: Baseline to immediately following intervention and 3 months follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.