Native and Valve in Valve Aortic Valve Failure
Conditions
Keywords
TAVR, Native Aortic Valve Failure, Valve in Valve Aortic Valve Failure, TAVR Associated Coronary Artery Obstruction, Electrosurgery
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.
Interventions
DEVICEASHI_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
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedure Success, Measured at Exit From the Catheterization Laboratory | 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) | 30 days | Freedom from major adverse clinical events (MACE) according to Valve Academic Research Consortium (VARC-2) at 30days. |
Countries
United States
Participant flow
Recruitment details
31 participants enrolled on protocol. 30 started the protocol, after 1 participant withdrew consent prior to the procedure.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Single Arm: Open-label Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 13 / 30 |
Outcome results
Primary
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.
Time frame: 30 days
Population: Subjects who underwent the BASILICA procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm: Open-label Treatment | Number of Participants Were Safety Endpoint is Freedom From Major Adverse Clinical Events (MACE) | 21 Participants |
Primary
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.
Time frame: 1 day
Population: Subjects who underwent the BASILICA procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm: Open-label Treatment | Number of Participants With Procedure Success, Measured at Exit From the Catheterization Laboratory | 28 participants |