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Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure

NCT02472106 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 9

Last updated 2016-08-31

No results posted yet for this study

Summary

This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures. The study product is CE marked for balloon aortic valvuloplasty (BAV), and is being investigated for an expanded intended use.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Post-dilatation

Post-dilatation in self-expanding TAVI device procedures

Sponsors & Collaborators

  • InterValve, Inc.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-08-31
Completion
2016-08-31

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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 NCT02472106 on ClinicalTrials.gov