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The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance

NCT01732835 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2017-03-10

Study results available
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Summary

This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D intra-annular mounting frame.

Conditions

  • Aortic Insufficiency

Interventions

DEVICE

HAART 300 Annuloplasty Device

Implantation of HAART 300 Annuloplasty Device for aortic valve repair

Sponsors & Collaborators

  • Biostable Science & Engineering

    lead INDUSTRY

Principal Investigators

  • Dominico Mazzitelli, MD · Munchen Heart Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-06-30
Completion
2015-11-30

Countries

  • Czechia
  • Germany

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 NCT01732835 on ClinicalTrials.gov