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NCT03381989 · ClinicalTrials.gov registry record · NA
Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation
A NA study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT03381989 is a NA study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 31 participants.
The verdict
NCT03381989, a NA study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study Summary
Background: TAVR is a common therapy for people with heart problems. It stands for transcatheter aortic valve replacement, TAVR can be a better option than surgery. But it isn t safe for everyone. It may block the arteries that supply blood to the heart muscle by pushing heart valve tissue outward. Researchers want to study a method that may make TAVR safer. It is known as Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA). Objective: To study the feasibility and safety of BASILICA in people at high risk of coronary artery obstruction that complicates TAVR. Eligibility: People at least 21 years old whose heart doctors do not think they can have TAVR safely Design: Participants will be screened by a team of heart specialists. They will have heart and blood tests. They will answer questions. Participants will have TAVR using BASILICA. They will get general anesthesia or they will be sedated. While using x-rays and echocardiography, doctors will cross and split the aortic valve leaflet using an electrified wire. A standard TAVR valve will be implanted. After the procedure, participants will have blood tests and physical exams. They will answer questions. They will have heart tests. Participants will have a scan within 1 month and after 12 months. They will have heart tests during follow-up visits in the first year. Sponsoring Institute: National Heart, Lung and Blood Institute
Interventions
- DEVICE ASHI_INTECC Astato XS 20 0.014 guidewire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2018-02-14 |
| Est. Completion | 2019-08-22 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03381989
The ClinicalTrials.gov registry entry for NCT03381989 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 31 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 1 intervention - of which ASHI_INTECC Astato XS 20 0.014 guidewire is the first listed.
NCT03381989 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03381989 about?
NCT03381989 is a clinical study titled "Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation". Background: TAVR is a common therapy for people with heart problems. It stands for transcatheter aortic valve replacement, TAVR can be a better option than surgery. But it isn t safe for everyone. It may block the arteries that supply blood to the heart muscle by pushing heart valve tissue outward....
What is the current status of trial NCT03381989?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2018-02-14. Estimated completion is 2019-08-22.
What interventions are being tested in trial NCT03381989?
The interventions under investigation include: ASHI_INTECC Astato XS 20 0.014 guidewire (DEVICE).
Who is sponsoring clinical trial NCT03381989?
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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