Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device (TAB-R)

Transluminal Aortic Balloon Valvuloplasty Registry (TAB-R)

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

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: V8 Balloon Aortic Valvuloplasty (BAV) Catheter

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
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90017
      • Good Samaritin Hospital
    • Los Angeles, California, United States, 90033
      • University of Southern Califormia
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital (with Minneapolis Heart Institute Foundation)
  • Tennessee
    • Nashville, Tennessee, United States, 37232-8802
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37203
      • Centennial Heart
  • Virginia
    • Richmond, Virginia, United States, 23229
      • Henrico's Doctors' Hospital
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Endpoint: Intra-Procedure Hemodynamic Changes	Absolute and percent change in mean aortic valve (AV) gradient and aortic valve area (AVA).	Intra-procedure
Efficacy Endpoint: Post-Procedure Hemodynamic Changes	Absolute and percent change in mean aortic valve (AV) gradient and aortic valve area (AVA).	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

Collaborators and Investigators

• Sponsor: InterValve, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (Estimate): March 31, 2014

Study Record Updates

• Last Update Posted (Estimate): March 1, 2016
• Last Update Submitted That Met QC Criteria: February 29, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Transcatheter Aortic Valve Replacement; Balloon Aortic Valvuloplasty; Valvuloplasty; Surgical Aortic Valve Replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 1058-001