Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

HAART Model 300 Annuloplasty Ring

Lead Sponsor:

Biostable Science & Engineering

Conditions:

Aortic Regurgitation

Eligibility:

All Genders

50+ years

Phase:

NA

Brief 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 aorti...

Detailed Description

Aortic Regurgitation, (also known as Aortic Insufficiency; AI), is the failure of the aortic valve to close completely during diastole which causes blood to flow from the aorta back into the left vent...

Eligibility Criteria

Inclusion

  • The subject is 50 years old or older
  • The subject has a tricuspid aortic valve morphology
  • Patients with documented severe aortic insufficiency with aortic annular dilation without severe concomitant aortic stenosis
  • Patients referred to center for documented moderate to severe Chronic aortic regurgitation (AR) associated with annular dilatation with or without cusp prolapse of one, two, or all three leaflets
  • Patients with or without Sinotubular Junction (STJ) dilatation or aortic root aneurysms
  • Patients who are free of coronary disease or those with evidence of minor stable (1-2 vessel) coronary disease
  • Subject is willing to comply with specified follow-up evaluations, including transesophageal echocardiography if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve
  • The subject has signed the written informed consent
  • The subject agrees to return for all follow-up evaluations for the duration of the study (i.e. geographically stable
  • The subject is New York Hospital Association (NYHA) class II or III

Exclusion

  • The subject has preexisting valve prosthesis in the atrial, the mitral, pulmonary, and/or tricuspid position
  • The subject requires an additional valve replacement
  • The subject's aortic valve morphology is not tricuspid
  • The subject has active endocarditis
  • Heavily calcified valves
  • Valvular retraction with severely reduced mobility
  • The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
  • The subject requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device
  • Leukopenia
  • Acute anemia (Hb \< 9mg%)
  • Platelet count \<100,000 cell/mm3
  • Need for emergency surgery for any reason
  • History of bleeding diathesis or coagulopathy or the subject refuses blood transfusions
  • Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 4 weeks after discontinuation of antibiotics)
  • Subjects in whom transesophageal echocardiography (TEE) is contraindicated
  • Non elective presentation
  • Low Ejection Fraction (EF) EF \< 40%
  • Life expectancy \< 1 year
  • Rheumatic disease
  • The subject has severe leaflet fenestration or leaflets damaged by endocarditis
  • The subject is or will be participating in a concomitant research study of an investigational product or has participated in such a study within the 30 days prior to screening
  • The subject is a minor, an illicit drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
  • The subject is pregnant or lactating
  • This patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up
  • The subject has not signed and dated the study informed consent
  • Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
  • Myocardial infarction (MI) within one month of trial inclusion
  • Have a known intolerance to titanium or polyester
  • Sole therapy for correction for patients with aortic root aneurysm
  • Subjects requiring simultaneous cardiac procedures
  • The subject has asymptomatic AR and a left ventricular ejection fraction (LVEF) \> 50%

Key Trial Info

Start Date :

January 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2014

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT01400841

Start Date

January 1 2012

End Date

September 1 2014

Last Update

January 13 2017

Active Locations (4)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (4 locations)

1

University Hospital Gasthuisberg

Leuven, Belgium, B-3000

2

Institut klinicke a experimantalni mediciny

Prague, Czechia, 1958/9

3

German Heart Institute

Berlin, Germany, 13353

4

German Heart Center Munich

Munich, Germany, 80636