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

Aortic Valve Stenosis Clinical Trial

— TAB-R  

Official title:

Transluminal Aortic Balloon Valvuloplasty Registry (TAB-R)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099942
• Other study ID #: 1058-001
• Status: Completed
• Phase: N/A
• First received: March 18, 2014
• Last updated: February 29, 2016
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: InterValve, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• V8 Balloon Aortic Valvuloplasty (BAV) Catheter
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

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
InterValve, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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.)	Yes
Secondary	Efficacy Endpoint: Intra-Procedure Hemodynamic Changes	Absolute and percent change in mean aortic valve (AV) gradient and aortic valve area (AVA).	Intra-procedure	No
Secondary	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.)	No
Secondary	Safety Endpoint: Aortic Valve (AV) Block at Discharge		At discharge, which is expected to be within 72 hours procedure.	Yes
Secondary	Safety Endpoint: Aortic Valve (AV) Block at 6-Month Follow-up		6-Month Follow-up	Yes