Native and Valve in Valve Aortic Valve FailureBASILICANCT03381989
Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation
A study testing ASHI_INTECC Astato XS 20 0.014 guidewire in people with Native and Valve in Valve Aortic Valve Failure, run by National Heart, Lung, and Blood Institute (NHLBI) at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Native and Valve in Valve Aortic Valve Failure
- What is being tested?
- ASHI_INTECC Astato XS 20 0.014 guidewire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Feb 2018to 22 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University Hospital
Atlanta, Georgia, 30322
Henry Ford Hospital
Detroit, Michigan, 48202
University of Washington
Seattle, Washington, 98195
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: 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).
Read more
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
Read the 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.
- Being tested
- ASHI_INTECC Astato XS 20 0.014 guidewire
- Keywords
- TAVR, Native Aortic Valve Failure, Valve in Valve Aortic Valve Failure, TAVR Associated Coronary Artery Obstruction, Electrosurgery
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASHI_INTECC Astato XS 20 0.014 guidewireDevice
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 group | Role | What they receive |
|---|---|---|
| Single arm: open-label treatment | Experimental | The BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR. Receives: Device: ASHI_INTECC Astato XS 20 0.014 guidewire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Procedure Success, Measured at Exit From the Catheterization Laboratory
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.
Measured: 1 day
Number of Participants Were Safety Endpoint is Freedom From Major Adverse Clinical Events (MACE)
Freedom from major adverse clinical events (MACE) according to Valve Academic Research Consortium (VARC-2) at 30days.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start14 Feb 2018
- Primary completion30 Sep 2018
- Study completion22 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Native and Valve in Valve Aortic Valve FailureStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert J Lederman, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381989
- Sponsor's protocol ID
- 999918018
- Other IDs
- 18-H-N018
- Acronym
- BASILICA
- Status last verified
- Sep 2020
- First submitted
- 21 Dec 2017
- Last updated
- 18 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Khan JM, Greenbaum AB, Babaliaros VC, Dvir D, Reisman M, McCabe JM, Satler L, Waksman R, Eng MH, Paone G, Chen MY, Bruce CG, Stine AM, Tian X, Rogers T, Lederman RJ. BASILICA Trial: One-Year Outcomes of Transcatheter Electrosurgical Leaflet Laceration to Prevent TAVR Coronary Obstruction. Circ Cardiovasc Interv. 2021 May;14(5):e010238. doi: 10.1161/CIRCINTERVENTIONS.120.010238. Epub 2021 May 18.
PubMed 34003670
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Latrogenic Coronary Artery Obstruction (BASILICA)
- ClinicalTrials.gov ID
- NCT03381989
- Acronym / sponsor ID
- BASILICA / 999918018
- Keywords
- TAVR, Native Aortic Valve Failure, Valve in Valve Aortic Valve Failure, TAVR Associated Coronary Artery Obstruction, Electrosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Posted 24 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm: open-label treatment | Experimental | Device: ASHI_INTECC Astato XS 20 0.014 guidewireThe BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASHI_INTECC Astato XS 20 0.014 guidewireA 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. | Device | Single arm: open-label treatment |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34003670Khan JM, Greenbaum AB, Babaliaros VC, Dvir D, Reisman M, McCabe JM, Satler L, Waksman R, Eng MH, Paone G, Chen MY, Bruce CG, Stine AM, Tian X, Rogers T, Lederman RJ. BASILICA Trial: One-Year Outcomes of Transcatheter Electrosurgical Leaflet Laceration to Prevent TAVR Coronary Obstruction. Circ Cardiovasc Interv. 2021 May;14(5):e010238. doi: 10.1161/CIRCINTERVENTIONS.120.010238. Epub 2021 May 18.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Lederman, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASHI_INTECC Astato XS 20 0.014 guidewire in people with Native and Valve in Valve Aortic Valve Failure, run by National Heart, Lung, and Blood Institute (NHLBI) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Procedure Success, Measured at Exit From the Catheterization Laboratory (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03381989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.