HAART Model 300 Annuloplasty Ring

NCT01400841 | Completed Results DMC

• 3 other identifiers: BSE 300TP-01-013TP-01-023
• Study Type: interventional
• Target: 18
• Locations: 3 countries
• Sites: 4

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 aortic valve using a 3-D intra-annular mounting frame

Conditions

Aortic Regurgitation

Keywords

Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Repair

Outcome Measures

Primary Outcomes (4)

• Primary Safety Outcome Measure: Event-free Survival

  Event-free survival is defined as survival free from device-related death

  1 month postprocedure

• Primary Safety Outcome Measure: Event-free Survival

  Event-free survival is defined as survival free from device-related death

  2 years postprocedure (extended follow-up)

• Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure

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

  6 months postprocedure

• Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure

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

  2 years postprocedure (extended follow-up)

Secondary Outcomes (27)

• Implant Procedure Success

  discharge or 14 days postprocedure, whichever comes first

• Implant Procedure Success

  2 years postprocedure (extended follow-up)

• Actuarial Freedom From Clinical Cardiovascular Events

  1 month postprocedure

• Actuarial Freedom From Clinical Cardiovascular Events

  2 years postprocedure

• Event-free Survival

  6 months postprocedure

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 device for aortic valve repair

HAART 300 Annuloplasty Device

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biostable Science & Engineering: lead

Study Sites (4)

University Hospital Gasthuisberg

Leuven, B-3000, Belgium

Location

Institut klinicke a experimantalni mediciny

Prague, 1958/9, Czechia

Location

German Heart Institute

Berlin, 13353, Germany

Location

German Heart Center Munich

Munich, 80636, Germany

Location

Related Publications (4)

• Mazzitelli D, Fischlein T, Rankin JS, Choi YH, Stamm C, Pfeiffer S, Pirk J, Detter C, Kroll J, Beyersdorf F, Griffin CD, Shrestha M, Nobauer C, Crooke PS, Schreiber C, Lange R. Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device. Eur J Cardiothorac Surg. 2016 Mar;49(3):987-93. doi: 10.1093/ejcts/ezv234. Epub 2015 Jul 8.

  PMID: 26156945 DERIVED

• Mazzitelli D, Stamm C, Rankin JS, Pfeiffer S, Fischlein T, Pirk J, Choi YH, Detter C, Kroll J, Beyersdorf F, Shrestha M, Schreiber C, Lange R. Leaflet reconstructive techniques for aortic valve repair. Ann Thorac Surg. 2014 Dec;98(6):2053-60. doi: 10.1016/j.athoracsur.2014.06.052. Epub 2014 Dec 1.

  PMID: 25468084 DERIVED

• Mazzitelli D, Stamm C, Rankin JS, Nobauer C, Pirk J, Meuris B, Crooke PS, Wagner A, Beavan LA, Griffin CD, Powers D, Nasseri B, Schreiber C, Hetzer R, Lange R. Hemodynamic outcomes of geometric ring annuloplasty for aortic valve repair: a 4-center pilot trial. J Thorac Cardiovasc Surg. 2014 Jul;148(1):168-75. doi: 10.1016/j.jtcvs.2013.08.031. Epub 2013 Oct 8.

  PMID: 24113022 DERIVED

• Mazzitelli D, Nobauer C, Rankin JS, Badiu CC, Dorfmeister M, Crooke PS, Wagner A, Schreiber C, Lange R. Early results of a novel technique for ring-reinforced aortic valve and root restoration. Eur J Cardiothorac Surg. 2014 Mar;45(3):426-30. doi: 10.1093/ejcts/ezt407. Epub 2013 Aug 19.

  PMID: 23959743 DERIVED

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

• Christof Stamm, M.D.

  German Heart Institute

  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: July 21, 2011
• First Posted: July 22, 2011
• Study Start: January 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: September 1, 2014
• Last Updated: January 13, 2017
• Results First Posted: November 22, 2016

Record last verified: 2016-11

Locations

DE (2); CZ (1); BE (1)