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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03381989
Recruitment Status : Active, not recruiting
First Posted : December 22, 2017
Results First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Tracking Information
First Submitted Date  ICMJE December 21, 2017
First Posted Date  ICMJE December 22, 2017
Results First Submitted Date  ICMJE March 10, 2020
Results First Posted Date  ICMJE March 24, 2020
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE February 14, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
  • The primary efficacy endpoint is clinical success at exit from catheterization lab [ Time Frame: Day 0 at exit from catheterization lab ]
  • The primary safety endpoint is freedom from major adverse clinical events (MACE) at 30days. [ Time Frame: 30 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
  • Clinical success irrespective of coronary artery stenting [ Time Frame: Day 0 ]
  • Clinical success without stroke [ Time Frame: Pre-discharge ]
  • Technical success of BASILICA only [ Time Frame: Day 0 ]
  • Coronary instantaneous wave-free pressure ratio (iFR) [ Time Frame: Day 0 ]
  • Survival [ Time Frame: Discharge, day 30, 12 months ]
  • Stroke or TIA [ Time Frame: Discharge, 30 days, 12 months ]
  • Access and vascular complications [ Time Frame: Day 30 ]
  • Peri-procedural and spontaneous acute myocardial infarction [ Time Frame: Discharge, day 30, 12 months ]
  • Pericardial effusion or tamponade [ Time Frame: Day 0 ]
  • VARC-2 bleeding complications [ Time Frame: Day 30 ]
  • AKIN acute kidney injury [ Time Frame: Day 30 ]
  • Freedom from hemolytic anemia related to BASILICA TAVR [ Time Frame: Discharge, day 30, 12 months ]
  • BASILICA Device or Procedure related technical failure [ Time Frame: Discharge ]
  • Rotational orientation [ Time Frame: 30 days ]
  • Hemodynamic instability caused by BASILICA before TAVR [ Time Frame: Day 0 ]
  • TAVR thrombosis [ Time Frame: Day 0 ]
  • Endocarditis [ Time Frame: Day 30, 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation
Official Title  ICMJE Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Latrogenic Coronary Artery Obstruction (BASILICA)
Brief 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

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Native and Valve in Valve Aortic Valve Failure
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: ASHI_INTECC Astato XS 20 0.014 guidewire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 10, 2020)
31
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2017)
60
Estimated Study Completion Date  ICMJE November 13, 2020
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03381989
Other Study ID Numbers  ICMJE 999918018
18-H-N018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert J Lederman, M.D. National Heart, Lung, and Blood Institute (NHLBI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP