Outcome Prediction in Patients With Aortic Stenosis After TAVI (PREDICT-TAVI)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06043180 |
Recruitment Status :
Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
|
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date | May 23, 2023 | ||||||||
First Posted Date | September 21, 2023 | ||||||||
Last Update Posted Date | September 21, 2023 | ||||||||
Estimated Study Start Date | October 1, 2023 | ||||||||
Estimated Primary Completion Date | February 1, 2026 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
|
||||||||
Original Primary Outcome Measures | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures |
|
||||||||
Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | 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). | ||||||||
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. |
||||||||
Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | Consecutive adult patients planned for transcatheter aortic valve implantation. | ||||||||
Condition | Aortic Stenosis, Severe | ||||||||
Intervention | Procedure: Transcatheter aortic valve implantation
Intervention on aortic valve for severe aortic stenosis
|
||||||||
Study Groups/Cohorts | Severe aortic stenosis
Aortic valve area <1.0 cm2/<0.6cm2/m2 or mean gradient >40mmHg or jet velocity >4.0 m/s.
Intervention: Procedure: Transcatheter aortic valve implantation
|
||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status | Not yet recruiting | ||||||||
Estimated Enrollment |
69 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | February 1, 2027 | ||||||||
Estimated Primary Completion Date | February 1, 2026 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Sex/Gender |
|
||||||||
Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
|
||||||||
Listed Location Countries | United Kingdom | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT06043180 | ||||||||
Other Study ID Numbers | 319698 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement | Not Provided | ||||||||
Current Responsible Party | Guy's and St Thomas' NHS Foundation Trust | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor | Guy's and St Thomas' NHS Foundation Trust | ||||||||
Original Study Sponsor | Same as current | ||||||||
Collaborators | King's College London | ||||||||
Investigators |
|
||||||||
PRS Account | Guy's and St Thomas' NHS Foundation Trust | ||||||||
Verification Date | May 2023 |