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

February 24, 2021 updated by: National Heart, Lung, and Blood Institute (NHLBI)

Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Latrogenic Coronary Artery Obstruction (BASILICA)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Transcatheter aortic valve replacement (TAVR) is an option to treat aortic valve stenosis or failure of a surgically implanted tissue valve. Sometimes TAVR displaces the diseased aortic valve leaflets outwards, causing life-threatening obstruction of the coronary arteries that supply blood to the heart. This is more common in surgically implanted tissue valves that are designed to achieve the largest aortic valve orifice area. Despite attempts to protect the coronary arteries from obstruction in these patients using coronary stents, the mortality of TAVR-associated coronary artery obstruction remains prohibitively high.

The investigators have developed and tested a technique to tear the existing aortic valve leaflet and enable TAVR in such patients. The procedure is called Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA).

The purpose of this study is to perform BASILICA in patients who have no good options to prevent coronary artery obstruction during TAVR.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:
  • Adults age greater than or equal to 21 years
  • High or extreme risk of surgical aortic valve replacement according to the local multidisciplinary heart team
  • Undergoing TAVR for valve-in-valve or native aortic valve failure ( on-label TAVR)
  • Deemed likely to suffer coronary artery obstruction from TAVR according to multidisciplinary heart team
  • Concurrence of the study eligibility committee

EXCLUSION CRITERIA:

  • Subjects unable to consent to participate, unless the subject has a legally authorized representative
  • Excessive target aortic leaflet calcification or masses on baseline CT
  • Survival despite successful procedure expected < 12 months
  • Planned concurrent valve intervention in the same setting (such as transcatheter mitral valve therapy or paravalvular leak therapy)
  • Subjects unwilling to participate or unwilling to return for study follow-up activities.
  • Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Single arm: open-label treatment
The BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Procedure Success, Measured at Exit From the Catheterization Laboratory
Time Frame: 1 day
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.
1 day
Number of Participants Were Safety Endpoint is Freedom From Major Adverse Clinical Events (MACE)
Time Frame: 30 days
Freedom from major adverse clinical events (MACE) according to Valve Academic Research Consortium (VARC-2) at 30days.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 14, 2018

Primary Completion (ACTUAL)

September 30, 2018

Study Completion (ACTUAL)

August 22, 2019

Study Registration Dates

First Submitted

December 21, 2017

First Submitted That Met QC Criteria

December 21, 2017

First Posted (ACTUAL)

December 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999918018
  • 18-H-N018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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