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A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure (ASC™) Device

NCT01721642 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2014-06-27

No results posted yet for this study

Summary

A pilot study to evaluate the safety and efficacy of the Apica Access, Stabilization, and Closure Device for accessing and closing the left ventricular apex during and after Transcatheter Aortic Valve Implantation (TAVI) procedures. Follow-up assessment will be made post-procedure, at 30 days and 90 days as well as longer term follow-up.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Apica Cardiovascular ASC Access, Stability and Closure Device

Access, stabilisation and closure of trans-apical approach for TAVI

Sponsors & Collaborators

  • Apica Cardiovascular Limited

    lead INDUSTRY

Principal Investigators

  • Thomas Walther, Prof · Kerckhoff Klinik

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-01-31
Completion
2013-03-31

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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 NCT01721642 on ClinicalTrials.gov