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NCT03195114 · ClinicalTrials.gov registry record
Cardiac MRI for Post-TAVR Paravalvular Leak Assessment
A clinical trial, sponsored by University of Pittsburgh.
- Completed
- Registry status
- 15
- Enrollment target
NCT03195114: Completed study, sponsored by University of Pittsburgh.
NCT03195114 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03195114 has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
Study Summary
The objectives of this study are to: a) evaluate and correlate the severity of paravalvular leak (PVL) assessed by both cardiac MRI and transthoracic echocardiography (TTE) after transcatheter aortic valve replacement (TAVR) with Medtronic Evolut-R or Evolut PRO bioprostheses; b) assess the inter and intraobserver variability of both imaging methods; and c) correlate the severity of PVL with post-TAVR changes in LV remodeling and clinical outcomes.
Primary Outcome
To test that PVL severity, assessed by CMR using regurgitant fraction and regurgitant volume, changes and regresses over a 6-month period post-TAVR (comparing those measurements at 1-month and 7-months post-TAVR).
Interventions
- DIAGNOSTIC_TEST Multimodality Imaging and Biomarkers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-01-01 |
| Est. Completion | 2019-02-15 |
What the finished NCT03195114 record still lists
NCT03195114 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Multimodality Imaging and Biomarkers is the first listed.
NCT03195114 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03195114 about?
NCT03195114 is a clinical study titled "Cardiac MRI for Post-TAVR Paravalvular Leak Assessment". The objectives of this study are to: a) evaluate and correlate the severity of paravalvular leak (PVL) assessed by both cardiac MRI and transthoracic echocardiography (TTE) after transcatheter aortic valve replacement (TAVR) with Medtronic Evolut-R or Evolut PRO bioprostheses; b) assess the inter an...
What is the current status of trial NCT03195114?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2017-01-01. Estimated completion is 2019-02-15.
What interventions are being tested in trial NCT03195114?
The interventions under investigation include: Multimodality Imaging and Biomarkers (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03195114?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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