The HAART 300 Annuloplasty Ring Extended Safety and Performance Trial Used in Surgical Repair of the Aortic Valve

Aortic Insufficiency Clinical Trial

Official title:

HAART 300 Trial Extended Safety and Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01732835
• Other study ID #: TP-01-022
• Status: Completed
• Phase: N/A
• First received: November 20, 2012
• Last updated: September 13, 2016
• Start date: December 2012
• Est. completion date: November 2015

Study information

• Verified date: June 2014
• Source: Biostable Science & Engineering
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is 18 years of age or older

• Subject has tri-leaflet aortic valve morphology

• Subject has documented aortic valve disease which may or may not include:

1. aortic valve insufficiency

2. aortic root pathology

3. pathology of the ascending aorta

4. patients with associated stable one or two vessel coronary disease requiring concomitant coronary bypass

• Subject is willing to comply with specified follow-up evaluations, including transesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve

• Subject has reviewed and signed the written informed consent form

• Subject agrees to return for all follow-up evaluations for the duration of the study (i.e.,. geographically stable)

Exclusion Criteria:

• The subject has pre-existing valve prosthesis in the aortic position

• The subject's aortic valve morphology is not tri-leaflet

• The subject has active endocarditis

• Heavily calcified valves

• The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis

• 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

• Low Ejection Fraction (EF) EF < 35%

• Life expectancy < 1 year

• 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

• Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)

• Myocardial Infarction (MI) within one month of trial inclusion

• The subject has a known intolerance to titanium or polyester

• The subject has documented unstable or > 2 vessel coronary disease

• The subject requires additional valve replacement or valve repair

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Insufficiency
• Aortic Valve Insufficiency

Intervention

Device:
• HAART 300 Annuloplasty Device
Implantation of HAART 300 Annuloplasty Device for aortic valve repair

Locations

Country	Name	City	State
Czech Republic	Institute of Clinical and Experimental Medicine	Prague
Germany	German Heart Center	Berlin
Germany	Klinik für Herz und Gefässchirurgie	Freiburg
Germany	Klinik und Poliklinik für Herz- und Gefäßchirurgie	Hamburg
Germany	Hannover Medical School (MHH)	Hannover
Germany	Uniklinik Köln	Köln
Germany	Munchen Heart Center	Munchen
Germany	Klinikum Nürnberg Süd	Nürnberg

Sponsors (1)

Lead Sponsor	Collaborator
Biostable Science & Engineering

Countries where clinical trial is conducted

Czech Republic,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary safety outcome measure: Survival defined as survival free from all cause death at 6 months postprocedure		6 months	Yes
Primary	Primary efficacy outcome measure: Aortic insufficiency (AI) change from baseline	Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)	6 months	No
Secondary	Implant procedure success	Success is defined as the absence of specified adverse events	discharge or 14 days postprocedure, whichever comes first	Yes
Secondary	Actuarial freedom from clinical cardiovascular events	Freedom from specified device and cardiovascular events	6 months	Yes
Secondary	Left ventricle dimensions, volume and mass change from baseline	Measures assessed by transthoracic echocardiography	6 months; 2 years	No
Secondary	Peak and mean systolic gradient change from baseline	Measures assessed by transthoracic echocardiography	6 months; 2 years	No
Secondary	Left ventricular ejection fraction change from baseline	Measure assessed by transthoracic echocardiography	6 months; 2 years	No
Secondary	Aortic insufficiency (AI) change from baseline	Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)	2 years	No
Secondary	New York Heart Association (NYHA) Functional Capacity Classification change from baseline	Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort	6 months; 2 years	No