HAART 200 Aortic Valve Annuloplasty Trial

NCT02071849 | Completed Results DMC

• 1 other identifier: TP-01-025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Aortic Insufficiency; Aortic Regurgitation

Outcome Measures

Primary Outcomes (2)

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

  6 months postprocedure

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

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

  6 months postprocedure

Secondary Outcomes (27)

• Implant Procedure Success

  discharge or 14 days postprocedure, whichever comes first

• Actuarial Freedom From Clinical Cardiovascular Events

  6 months postprocedure

• Actuarial Freedom From Clinical Cardiovascular Events

  2 years postprocedure

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

  2 years

• Aortic Insufficiency (AI) at 2 Years

  Baseline and 2 years

Study Arms (1)

Aortic Valve Repair

EXPERIMENTAL

Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction

Device: HAART 200 Aortic Valve Annuloplasty Device

Interventions

HAART 200 Aortic Valve Annuloplasty Device DEVICE

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

Aortic Valve Repair

Eligibility Criteria

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

You may qualify if:

• The subject is 18 years of age or older
• The subject has bi-leaflet aortic valve morphology
• The subject has documented aortic valve disease which may or may not include:
• Aortic valve insufficiency
• Ascending aortic or aortic root pathology
• Other pathology of the ascending aorta that requires elective aortic replacement
• Associated stable one or two vessel coronary disease requiring concomitant coronary bypass
• Patients with recurrent severe AI (Grade 3 or 4) after prior bicuspid repair who are undergoing re-repair because of annular re-dilatation
• All bicuspid annular and leaflet configurations will be included
• The subject needs:
• correction of BAV annular dilatation in patients with chronic AI and dilated annulus
• restoration of a circular annular shape in patients with bicuspid valve and expansion of sinus to sinus dimensions
• stabilization of annular geometry long-term in rare bicuspid valve patients with severe AI and minimal annular dilatation
• The 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
• The subject has reviewed and signed the written informed consent form

You may not qualify if:

• All patients will be excluded who require emergency surgery for any reason.
• All the patients who have had a prior heart valve replacement
• The subject's aortic valve morphology is not bicuspid.
• The subject has active endocarditis
• The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
• Heavily calcified BAV valves, calcified aortic roots, or "porcelain aortas"
• Leukopenia with a White Blood Cell (WBC) of less than 3000
• Acute anemia with a Hgb less than 9mg%
• Platelet count less than 100,000 cells/mm3
• History of a defined bleeding diathesis or coagulopathy or the subject refuses blood transfusions
• Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 2-4 weeks after discontinuation of antibiotics)
• Subjects in whom transesophageal echocardiography (TEE) is contraindicated
• Low Ejection Fraction (EF) \< 35%
• Life expectancy \< 1 year, or severe comorbidities, such as dialysis or severe Chronic Obstructive Pulmonary Disease (COPD)
• 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 (4)

München Heart Center

München, Bavaria, 80636, Germany

Location

Uniklinik Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Klinik und Poliklinik für Herz- und Gefäßchirurgie

Hamburg, 20246, Germany

Location

Klinikum Nürnberg Süd

Nuremberg, 90471, Germany

Location

Related Publications (1)

• Mazzitelli D, Pfeiffer S, Rankin JS, Fischlein T, Choi YH, Wahlers T, Nobauer C, Schreiber C, Lange R. A Regulated Trial of Bicuspid Aortic Valve Repair Supported by Geometric Ring Annuloplasty. Ann Thorac Surg. 2015 Jun;99(6):2010-6. doi: 10.1016/j.athoracsur.2015.01.050. Epub 2015 Apr 10.

  PMID: 25865762 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

• Dominico Mazzitelli, MD

  München 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: February 17, 2014
• First Posted: February 26, 2014
• Study Start: September 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2016
• Last Updated: April 17, 2017
• Results First Posted: March 20, 2017

Record last verified: 2017-03

Locations

DE (4)