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HAART 200 Aortic Valve Annuloplasty Trial

NCT02071849 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-04-17

Study results available
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Summary

The HAART 200 "Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction" Trial is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART 200 bicuspid annuloplasty ring when used to surgically stabilize the aortic valve annulus in patients undergoing repair of bicuspid aortic valves (BAV) for predominant aortic insufficiency (AI).

Conditions

  • Aortic Insufficiency

Interventions

DEVICE

HAART 200 Aortic Valve Annuloplasty Device

Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .

Sponsors & Collaborators

  • Biostable Science & Engineering

    lead INDUSTRY

Principal Investigators

  • Dominico Mazzitelli, MD · München 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
2013-09-30
Primary Completion
2015-04-30
Completion
2016-08-31

Countries

  • 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 NCT02071849 on ClinicalTrials.gov