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Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation

NCT03381989 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-03-18

Study results available
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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

Conditions

  • Native and Valve in Valve Aortic Valve Failure

Interventions

DEVICE

ASHI_INTECC Astato XS 20 0.014 guidewire

A coaxial traversal guiding catheter system (typically tandem catheters) directs electrosurgery devices (typically a rigid 0.014 guidewire inside a polymer jacket wire convertor) against the base of the coronary cusp targeted for laceration, using fluoroscopic and/or echocardiographic guidance. Traversal is accomplished by transcatheter electrosurgery by connecting the back end of the 0.014 guidewire to an electrosurgery pencil during short bursts of pure, cutting radiofrequency energy at ap-proximately 30W. The guidewire is repositioned as needed until it crosses the aortic leaflet and is snare-retrieved and externalized. Laceration is performed by positioning the laceration surface along the intended leaflet base, and applying tension on both free ends of the guidewire while simultaneously apply electrosurgery energy (typically 70W) in short bursts, until the laceration is complete and the guidewire is free.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Robert J Lederman, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-14
Primary Completion
2018-09-30
Completion
2019-08-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03381989 on ClinicalTrials.gov