Aortic Valve Failure, Valvular Heart Disease
Conditions
Keywords
Structural heart disease interventions, TAVR, TAVR Associated Coronary Artery Obstruction, Electrosurgery, Native Aortic Valve Failure, Bioprosthetic Aortic Valve Failure
Brief summary
Background: Replacing a valve in the heart can save many people's lives. The procedure is called transcatheter aortic valve replacement (TAVR). In rare cases, a flap of tissue called a leaflet can shift during TAVR; the leaflet may block blood flow to the coronary arteries, which supply blood to the heart muscle. About 50% of people who experience this problem will die. To reduce this risk, doctors will cut this leaflet during TAVR. But the tools used to cut the leaflet were originally designed for other purposes. Using these tools during TAVR can be complicated and risky. Researchers want to make TAVR safer. Objective: To test a new device (TELLTALE) designed specifically for use during TAVR. Eligibility: People aged 21 years and older who are undergoing TAVR and who are at high risk of coronary artery obstruction. Design: Participants will be screened. They will have routine tests that are done before undergoing TAVR. Before the procedure, participants will complete a questionnaire. They will talk about how their heart disease affects their quality of life. Their physical abilities and their risk of stroke will be assessed. Participants will be admitted to the hospital for TAVR. They will be placed under general anesthesia or moderate sedation. The procedure will be performed using the TELLTALE guidewire system. Participants will repeat the tests of their physical abilities after the procedure. They will also repeat the questionnaire about their quality of life. These will be repeated again at a follow-up visit in 30 days. Participants will have a final study visit after 90 days. This visit may be in person or remote.
Detailed description
Transcatheter aortic valve implantation (TAVR) may cause life threatening coronary artery obstruction, whether implanted in native aortic stenosis or bioprosthetic aortic valve failure. We have developed and validated the techniques of BASILICA (Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during transcatheter aortic valve replacement), using bedside modification of off-the-shelf guidewires. These bedside modifications require additional assembly steps and special expertise, and thereby risks procedure failure and complications. Transmural Systems and NHLBI have developed a purpose-built electrosurgical guidewire system (TELLTALE) to simplify the BASILICA-TAVR procedure. The purpose of this protocol is to test the efficacy and safety of this purpose-built guidewire in the setting of BASILICA-TAVR.
Interventions
DEVICETELLTALE BASILICA procedure
The TELLTALE BASILICA procedure has five steps: (1) engagement of the target leaflet with a guiding catheter; (2) electrosurgical leaflet traversal with the TELLTALE guidewire, (3) preparation and positioning of the TELLTALE guidewire electrosurgical leaflet laceration surface; (4) electrosurgical leaflet laceration with the TELLTALE guidewire, immediately followed by (5) TAVR. These are all guided by fluoroscopy, with adjunctive echocardiography as needed.
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 109 Years
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: In order to be eligible to participate in the study, candidates must meet all of the following criteria: * Adults age \>= 21 years * High or prohibitive risk of surgical aortic valve replacement according to the local multidisciplinary heart team * Undergoing TAVR for bioprosthetic aortic valve failure or native aortic stenosis ( on-label TAVR) * Local multidisciplinary heart team determines subject to be at high risk of TAVR-induced coronary artery obstruction * Deemed likely to suffer coronary artery obstruction from TAVR based on NHLBI Core lab analysis of CT, any of * Risk is narrow Sinus of Valsalva: (a) Leaflet height is greater than coronary artery height, and (b) Virtual transcatheter valve-to-coronary (VTC) distance \< 4mm * Risk is Sinus sequestration: (a) Threatening leaflet height is greater than sinotubular junction, and (b) Virtual transcatheter valve-to-sinotubular-junction distance (VTS) \< 2mm at the affected Sinus * Concurrence of the Study Eligibility Committee * Able to understand the protocol, consents in writing to participate, and willing to comply with all study procedures for the duration of the study
Exclusion criteria
* Requires doppio (two-leaflet) BASILICA * Flail target leaflet at baseline * Excessive target aortic leaflet calcification (no basal calcium-free window or potentially obstructive calcific masses) on baseline CT * Planned provisional (pre-position coronary artery) stents despite BASILICA * Requires non-femoral access * Requires concomitant procedures during TAVR (such as percutaneous coronary intervention for baseline obstructive coronary artery disease) * Chronic kidney disease KDIGO stage 4 or 5 (eGFR \< 29 ml/min/1.73m2) or renal replacement therapy * Not expected to survive for 12 months * Pregnant at the time of intended treatment (day 0)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participant That Experienced Technical Success With the TELLTALE Guidewire System | 1 minute following procedure discharge (Exit from the catheterization laboratory) | The primary efficacy endpoint is technical success, which is defined when the following criteria are all met: 1. Successful electrosurgical leaflet traversal using the TELLTALE Guidewire 2. Successful electrosurgical leaflet laceration using the TELLTALE Guidewire 3. Successful retrieval of the TELLTALE Guidewire System |
| Number of Inpatient Safety Events | Upon discharge from the index hospital admission, up to 30 days | Inpatient safety as defined by: 1. Freedom from all-cause mortality as defined as the total number of deaths from any cause 2. Freedom from stroke, both disabling and non-disabling * Disabling stroke according to VARC-3 is defined as a stroke resulting in significant, persistent neurological deficits that impact a patient's ability to perform daily activities. * Non-disabling stroke according to VARC-3, involves stroke symptoms that don't significantly impair a patient's ability to perform daily activities or lead to a worsening of their pre-stroke disability level. 3. Freedom from acute coronary artery obstruction 4. Freedom from emergency cardiac surgery or reintervention related to the TELLTALE BASILICA procedure or device- 5. Freedom from BASILICA-related complications including coronary artery perforation, coronary artery dissection, aortic dissection, cardiac free wall perforation, or systemic embolization of a native or bioprosthetic leaflet |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Safety Events | Up to Day 30 | 30-day safety as assessed by freedom from * Major Adverse Cardiovascular Events defined by no periprocedural myocardial infarction, cerebrovascular events, and periprocedural all-cause mortality * All-cause mortality: defined as total number of deaths from any cause * All stroke (disabling and non-disabling per VARC-3) * Disabling results in significant, persistent neurological deficits that impact daily activities * Non-disabling involves stroke symptoms that don't significantly impair daily activities or lead to worsening of their pre-stroke level * Bleeding VARC-3 Type 2 or greater requiring two or more units of transfused blood or hemoglobin drop \>3g/dL * Major vascular, access-related, or cardiac structural complication according to VARC-3, including coronary obstruction * Acute kidney injury stage 3 or 4 * Moderate or severe aortic regurgitation * New permanent pacemaker due to procedure-related conduction abnormalities * Surgery or intervention related to the TELLTALE device |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert J Lederman, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 85 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 81 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 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 | 5 Participants |
| Race (NIH/OMB) White | 82 Participants |
| Region of Enrollment United States | 90 Participants |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 90 |
| other Total, other adverse events | 62 / 90 |
| serious Total, serious adverse events | 36 / 90 |
Outcome results
None listed