Brief Title
Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device
Official Title
Transluminal Aortic Balloon Valvuloplasty Registry (TAB-R)
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.
Study Type
Observational [Patient Registry]
Primary Outcome
Efficacy Endpoint: V8 Device Performance
Secondary Outcome
Efficacy Endpoint: Intra-Procedure Hemodynamic Changes
Condition
Aortic Valve Stenosis
Intervention
V8 Balloon Aortic Valvuloplasty (BAV) Catheter
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
103
Start Date
March 2014
Completion Date
December 2015
Primary Completion Date
December 2015
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.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02099942
Organization ID
1058-001
Responsible Party
Sponsor
Study Sponsor
InterValve, Inc.
Study Sponsor
, ,
Verification Date
February 2016