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NCT03015194 · ClinicalTrials.gov registry record · NA
NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation
A NA study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT03015194 is a NA study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 32 participants.
The verdict
NCT03015194, a NA study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study Summary
Background: Transcatheter mitral valve replacement (TMVR) is recommended for some people with mitral valve heart problems. But the usual TMVR techniques might cause an obstruction for some people. A new technique is called LAMPOON. It may have less risk of obstruction. Participants in this study will be among the first in the world to have this technique done. Objectives: To test the safety and effectiveness of the LAMPOON technique in TMVR. Eligibility: Adults ages 21 and over who are recommended to have TMVR with LAMPOON Design: Participants will be screened with medical history and exam and by review of medical records. Participants will have blood tests, an ECG, a heart CT scan, and an echocardiogram before the procedure. Participants will have TMVR with LAMPOON. They will have anesthesia or moderate sedation for the procedure. Doctors will use a wire to split the diseased mitral valve and move it out of the way before inserting the artificial mitral valve. Participants will recover in an inpatient recovery unit. They will repeat the previous tests before leaving the hospital, 1 month later, 6 months later and 1 year later. They will have yearly follow-up phone calls for about 5 years. In the event of a participant's death, researchers will ask for an autopsy and to analyze the heart. Permission for this is not required as part of the study.
Interventions
- DEVICE Edwards SAPIEN 3 transcatheter heart valve
- DEVICE ASHI INTECC Astato XS 20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-06-20 |
| Est. Completion | 2023-04-13 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03015194
The ClinicalTrials.gov registry entry for NCT03015194 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Edwards SAPIEN 3 transcatheter heart valve is the first listed.
NCT03015194 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03015194 about?
NCT03015194 is a clinical study titled "NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation". Background: Transcatheter mitral valve replacement (TMVR) is recommended for some people with mitral valve heart problems. But the usual TMVR techniques might cause an obstruction for some people. A new technique is called LAMPOON. It may have less risk of obstruction. Participants in this study wi...
What is the current status of trial NCT03015194?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2017-06-20. Estimated completion is 2023-04-13.
What interventions are being tested in trial NCT03015194?
The interventions under investigation include: Edwards SAPIEN 3 transcatheter heart valve (DEVICE), ASHI INTECC Astato XS 20 (DEVICE).
Who is sponsoring clinical trial NCT03015194?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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