Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device

Completed

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT02099942
• Lead Sponsor: InterValve, Inc.

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-26
• Study First Posted: 2014-03-31
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-29
• Last Update Posted: 2016-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy Endpoint: V8 Device Performance	Intra-procedure	Successful balloon fixation: proximal and distal balloon segments are securely fixed on either side of the aortic valve annulus following inflation.
Safety Endpoint: Serious Adverse Events (SAE)	Intra-procedure until discharge or 72 hours post-procedure, whichever comes first. (Typical discharge is expected to be within 72 hours.)	The composite of SAEs as defined by the Valve Academic Research Consortium (VARC).

Secondary Outcome Measures

Name	Time	Method
Efficacy Endpoint: Intra-Procedure Hemodynamic Changes	Intra-procedure	Absolute and percent change in mean aortic valve (AV) gradient and aortic valve area (AVA).
Efficacy Endpoint: Post-Procedure Hemodynamic Changes	Within 72 hours of procedure or discharge, whichever is first. (Typical discharge is expected to be within 72 hours.)	Absolute and percent change in mean aortic valve (AV) gradient and aortic valve area (AVA).
Safety Endpoint: Aortic Valve (AV) Block at Discharge	At discharge, which is expected to be within 72 hours procedure.
Safety Endpoint: Aortic Valve (AV) Block at 6-Month Follow-up	6-Month Follow-up

Trial Locations

Locations (7)

Good Samaritin Hospital; 🇺🇸 Los Angeles, California, United States

University of Southern Califormia; 🇺🇸 Los Angeles, California, United States

Centennial Heart; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Abbott Northwestern Hospital (with Minneapolis Heart Institute Foundation); 🇺🇸 Minneapolis, Minnesota, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Henrico's Doctors' Hospital; 🇺🇸 Richmond, Virginia, United States