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

NCT02099942 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 103

Last updated 2016-03-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • InterValve, Inc.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02099942 on ClinicalTrials.gov