Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device
Completed
Conditions studied: Aortic Valve Stenosis
In brief
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
Key facts
- Study ID
- NCT02099942
- Run by
- InterValve, Inc.
- People needed
- 103
- Starts
- 2014-03-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2016-03-01
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Good Samaritin Hospital — Los Angeles, California, United States
- University of Southern Califormia — Los Angeles, California, United States
- Abbott Northwestern Hospital (with Minneapolis Heart Institute Foundation) — Minneapolis, Minnesota, United States
- Centennial Heart — Nashville, Tennessee, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- Henrico's Doctors' Hospital — Richmond, Virginia, United States
- University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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