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

NCT02099942 | Completed

• 1 other identifier: 1058-001
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 7

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

Conditions

Aortic Valve Stenosis

Keywords

Balloon Aortic Valvuloplasty; Valvuloplasty; Transcatheter Aortic Valve Replacement; Surgical Aortic Valve Replacement

Outcome Measures

Primary Outcomes (2)

• Efficacy Endpoint: V8 Device Performance

  Successful balloon fixation: proximal and distal balloon segments are securely fixed on either side of the aortic valve annulus following inflation.

  Intra-procedure

• Safety Endpoint: Serious Adverse Events (SAE)

  The composite of SAEs as defined by the Valve Academic Research Consortium (VARC).

  Intra-procedure until discharge or 72 hours post-procedure, whichever comes first. (Typical discharge is expected to be within 72 hours.)

Secondary Outcomes (4)

• Efficacy Endpoint: Intra-Procedure Hemodynamic Changes

  Intra-procedure

• 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.)

• 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

Interventions

V8 Balloon Aortic Valvuloplasty (BAV) Catheter DEVICE

The V8 device can be used for BAV as follows: * as stand-alone intervention * as a bridge to transcatheter aortic valve replacement (TAVR) * as a bridge to surgical aortic valve replacement (SAVR) * as an intraprocedural predilatation prior to TAVR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• InterValve, Inc.: lead

Study Sites (7)

Good Samaritin Hospital

Los Angeles, California, 90017, United States

Location

University of Southern Califormia

Los Angeles, California, 90033, United States

Location

Abbott Northwestern Hospital (with Minneapolis Heart Institute Foundation)

Minneapolis, Minnesota, 55407, United States

Location

Centennial Heart

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-8802, United States

Location

Henrico's Doctors' Hospital

Richmond, Virginia, 23229, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Catheters

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 31, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

US (7)