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TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium (TriRec)

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ClinicalTrials.gov Identifier: NCT03600662
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Collaborator:
Department of Cardiovascular Surgery, German Heart Center Munich
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

Study Description
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Brief Summary:
Reconstruction of the aortic valve using the tri-leaflet repair technique is non-inferior with regard to effective orifice area (EOA) to surgical aortic valve replacement (SAVR) with a biological prosthesis (St. Jude Trifecta GT) as gold- standard.

Condition or disease Intervention/treatment Phase
Alternative Surgical Treatment for Aortic Valve Disease Other: TriRec Other: Aortic valve replacement Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TriRec - Trileaflet Reconstruction of the Aortic Valve
Actual Study Start Date : January 18, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2030

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Arms and Interventions
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Arm Intervention/treatment
Experimental: TriRec
Trileaflet Reconstruction of the Aortic Valve
 Other: TriRec
Trileaflet Reconstruction of the Aortic Valve
Experimental: Aortic valve replacement
Biological prosthesis, Device: St. Jude Medical Trifecta GT
 Other: Aortic valve replacement
Biological Prosthesis, Device: St. Jude Medical Trifecta GT


Outcome Measures
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Primary Outcome Measures :
  1. Effective orifice area [ Time Frame: 10th postoperative day +/- 4 days ]
    Effective orifice area in cm2 (EOA) either after the TriRec- procedure or surgical valve replacement with the St. Jude Medical Trifecta GT Valve, measured by echocardiography


Secondary Outcome Measures :
  1. Effective orifice area [ Time Frame: after 6 months, 1 year and thereafter annually until the 10th postoperative year ]
    Effective orifice area in cm2 (EOA) either after the TriRec- procedure or surgical valve replacement with the St. Jude Medical Trifecta GT Valve, measured by echocardiography

  2. Maximum and mean aortic pressure gradients [ Time Frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. ]
  3. Estimation of aortic regurgitation, if applicable [ Time Frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year ]
  4. Left ventricular ejection fraction [ Time Frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year ]
  5. Left ventricular endsystolic and -diastolic diameter [ Time Frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year ]
  6. Left ventricular endsystolic and -diastolic volume [ Time Frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year ]
  7. Left atrial diameter [ Time Frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year ]
  8. Freedom from aortic valve reintervention at discharge [ Time Frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year ]
  9. Freedom from Mortality [ Time Frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. ]
  10. Freedom from Stroke [ Time Frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. ]
  11. Freedom from Myocardial infarction [ Time Frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. ]
  12. Freedom from conduction disturbances leading to permanent pacemaker implantation [ Time Frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. ]
  13. Freedom from Endocarditis [ Time Frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. ]
  14. Freedom from Bleeding requiring re-thoracotomy [ Time Frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 50 years
  • Documented symptomatic moderate or greater aortic stenosis or severe insufficiency
  • Aortic annulus > 19 mm
  • Written informed consent of the patient.

Exclusion Criteria:

  • Concomitant intervention of the aortic root
  • Concomitant intervention of the aortic arch
  • Concomitant valve surgery
  • Emergency surgery for any reason
  • Neurological events (i.e. stroke, TIA) within 6 months preoperatively
  • Coagulation disorders (including thrombocytopenia < 100.000/ml)
  • Porcelain aorta
  • Active endocarditis or other active systemic infections
  • Participating in another trial that may influence the outcome of this trial
  • Pregnancy
  • Dual antiplatelet therapy
  • Previous cardiac surgery (excluding percutaneous procedures)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03600662


Contacts
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Contact: Markus Krane, MD, PhD +4989-1218 ext 4111 krane@dhm.mhn.de

Locations
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Germany
Department of Cardiovascular Surgery, German Heart Center Munich Recruiting
Munich, Bayern, Germany, 80336
Contact: Markus Krane, MD, PhD    +4989-1218 ext -4111    krane@dhm.mhn.de   
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Department of Cardiovascular Surgery, German Heart Center Munich
Investigators
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Study Chair: Markus Krane, MD, PhD Department of Cardiovascular Surgery, German Heart Center Munich
More Information
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Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT03600662    
Other Study ID Numbers: 389/17S
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deutsches Herzzentrum Muenchen:
aortic stenosis
aortic regurgitation
Trileaflet reconstruction of the aortic valve
Biological aortic valve prosthesis
Effective orifice area
Additional relevant MeSH terms:
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Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases