Clinical trial NCT02099942: Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device
Official title: Transluminal Aortic Balloon Valvuloplasty Registry (TAB-R)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: Balloon Aortic Valvuloplasty
Valvuloplasty
Transcatheter Aortic Valve Replacement
Surgical Aortic Valve Replacement
Lead sponsor: InterValve, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-31
Enrollment: 103
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic - Patients at each enrolling clinic who are to be treated with the InterValve V8 device for balloon aortic valvuloplasty (BAV) are eligible for enrollment.

Brief summary: This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV). Additional analyses or calculations may be obtained from the imaging or evaluations already performed per the sites' standard of care

Detailed description: The study is an open-label observational study involving a minimum of 10 centers. A minimum of 100 patients, including a minimum of 30 stand-alone balloon aortic valvuloplasty (BAV) treatment patients, will be enrolled. Enrollment will continue until all 3 of these conditions are met.

BAV-only patients will be followed through a 6-month post-treatment telephone follow up. Patients treated with the V8 device for BAV as a bridge to transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) or as an intraprocedural predilatation prior to TAVR, will exit the study at the time of the TAVR or SAVR implant or at 6 months post-BAV treatment, whichever comes first.

Eligibility criteria: Inclusion Criteria:

* Symptomatic severe aortic stenosis (AS) patients who are not suitable candidates for aortic valve replacement surgery at the time of BAV procedure.
* Subject meets the Indication For Use.
* Probable survival to hospital discharge.
* Subject is competent, willing to comply with evaluations, understands risks, benefits and alternatives and has signed the Informed Consent Form. Alternatively, the legal guardian of the patient is able to give consent to participate.

Exclusion Criteria:

* Patient has undergone previous AVR
* Greater or equal to 3+ aortic insufficiency by echocardiogram obtained prior to planned BAV or intra-procedural predilation TAVR procedure
* Non-valvular AS
* Known congenital AV abnormality (e.g., bicuspid AV)
* Cardiogenic shock, as defined by a consistent systolic blood pressure \<80 mmHg off vasopressors or \<90 mmHg on vasopressors.
* Bacterial endocarditis ≤ 12 months prior to planned BAV procedure
* Unable to take aspirin (acetyl salicylic acid, ASA) or thienopyridine
* Any illness or condition which, in the Investigator's judgment, will compromise patient safety, or interfere with the interpretation of the treatment results
* Echocardiographic evidence of intracardiac mass, thrombus or vegetation.

Primary outcomes:
measure: Efficacy Endpoint: V8 Device Performance
timeFrame: Intra-procedure
measure: Safety Endpoint: Serious Adverse Events (SAE)
timeFrame: Intra-procedure until discharge or 72 hours post-procedure, whichever comes first. (Typical discharge is expected to be within 72 hours.)
Secondary outcomes:
measure: Efficacy Endpoint: Intra-Procedure Hemodynamic Changes
timeFrame: Intra-procedure
measure: Efficacy Endpoint: Post-Procedure Hemodynamic Changes
timeFrame: Within 72 hours of procedure or discharge, whichever is first. (Typical discharge is expected to be within 72 hours.)
measure: Safety Endpoint: Aortic Valve (AV) Block at Discharge
timeFrame: At discharge, which is expected to be within 72 hours procedure.
measure: Safety Endpoint: Aortic Valve (AV) Block at 6-Month Follow-up
timeFrame: 6-Month Follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Good Samaritin Hospital
state: California
city: Los Angeles
country: United States
facility: University of Southern Califormia
state: California
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital (with Minneapolis Heart Institute Foundation)
state: Minnesota
city: Nashville
country: United States
facility: Centennial Heart
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Richmond
country: United States
facility: Henrico's Doctors' Hospital
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: