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HAART Model 300 Annuloplasty Ring

NCT01400841 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-01-13

Study results available
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Summary

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

Conditions

  • Aortic Regurgitation

Interventions

DEVICE

HAART 300 Annuloplasty Device

Implantation of device for aortic valve repair

Sponsors & Collaborators

  • Biostable Science & Engineering

    lead INDUSTRY

Principal Investigators

  • Christof Stamm, M.D. · German Heart Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-04-30
Completion
2014-09-30

Countries

  • Belgium
  • 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 NCT01400841 on ClinicalTrials.gov