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Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation
NA trial testing ASHI_INTECC Astato XS 20 0.014 guidewire in Native and Valve in Valve Aortic Valve Failure in 31 participants. Completed in 22 August 2019.
| Lead sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 14 February 2018 |
| Primary completion | 30 September 2018 |
| Estimated completion | 22 August 2019 |
| Sites | 4 locations across United States |
National Heart, Lung, and Blood Institute (NHLBI)
21 and older, any sex, with Native and Valve in Valve Aortic Valve Failure. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Successful BASILICA traversal and laceration; immediate survival; successful first TAVR device implantation; absence of coronary artery obstruction; and freedom from emergency cardiac surgery or reintervention related to the BASILICA or TAVR procedure.
| Group | Value | 95% CI |
|---|---|---|
| Single Arm: Open-label Treatment | 28 |
Freedom from major adverse clinical events (MACE) according to Valve Academic Research Consortium (VARC-2) at 30days.
| Group | Value | 95% CI |
|---|---|---|
| Single Arm: Open-label Treatment | 21 |
Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Single Arm: Open-label Tre… |
|---|---|---|
| Major vascular complication | Injury, poisoning and procedural complications | — |
| Ischemic stroke | Nervous system disorders | — |
| Cardiac pacemaker insertion | Cardiac disorders | — |
| Hemodynamic instability from lacertation requiring vasopressors | Cardiac disorders | — |
| Life threatening bleeding | Injury, poisoning and procedural complications | — |
| Secondary myocardial infarction | Cardiac disorders | — |
| AKI - Acute Kidney Injury Stage 2/3 | Renal and urinary disorders | — |
Most-reported serious reactions: Major vascular complication, Ischemic stroke, Cardiac pacemaker insertion, Hemodynamic instability from lacertation requiring vasopressors, Life threatening bleeding, Secondary myocardial infarction, AKI - Acute Kidney Injury Stage 2/3.
Data from ClinicalTrials.gov NCT03381989 adverse events section.
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
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing