The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance

NCT01732835 | Completed Results DMC

• 1 other identifier: TP-01-022
• Study Type: interventional
• Target: 68
• Locations: 2 countries
• Sites: 8

Brief 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

Keywords

Aortic Insufficiency (AI) Aortic Regurgitation (AR)

Outcome Measures

Primary Outcomes (2)

• Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure

  6 months

• Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months

  Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)

  6 months

Secondary Outcomes (26)

• Implant Procedure Success

  discharge or 14 days postprocedure, whichever comes first

• Actuarial Freedom From Clinical Cardiovascular Events

  6 months

• Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure

  2 years

• Aortic Insufficiency (AI) at 2 Years

  2 years

• New York Heart Association (NYHA) Functional Capacity Classification at 6 Months

  6 months

Study Arms (1)

HAART 300 Annuloplasty Device

EXPERIMENTAL

Implantation of HAART 300 Annuloplasty Device for aortic valve repair

Device: HAART 300 Annuloplasty Device

Interventions

HAART 300 Annuloplasty Device DEVICE

Implantation of HAART 300 Annuloplasty Device for aortic valve repair

HAART 300 Annuloplasty Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• aortic valve insufficiency
• aortic root pathology
• pathology of the ascending aorta
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Biostable Science & Engineering: lead

Study Sites (8)

Institute of Clinical and Experimental Medicine

Prague, 140 21, Czechia

Location

German Heart Center

Berlin, 80636, Germany

Location

Uniklinik Köln

Cologne, 50937, Germany

Location

Klinik für Herz und Gefässchirurgie

Freiburg im Breisgau, 79106, Germany

Location

Klinik und Poliklinik für Herz- und Gefäßchirurgie

Hamburg, 20246, Germany

Location

Hannover Medical School (MHH)

Hanover, 30625, Germany

Location

Munchen Heart Center

München, Germany

Location

Klinikum Nürnberg Süd

Nuremberg, 90471, Germany

Location

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: John Wheeler
• Organization: Biostable Science and Engineering, Inc.

John.wheeler@biostable-s-e.com

512-386-1996

Study Officials

• Dominico Mazzitelli, MD

  Munchen Heart Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 26, 2012
• Study Start: December 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: November 1, 2015
• Last Updated: March 10, 2017
• Results First Posted: January 31, 2017

Record last verified: 2017-01

Locations

DE (7); CZ (1)