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

TriRec - Trileaflet Reconstruction of the Aortic Valve

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.

Study Overview

• Status: Recruiting
• Conditions: Alternative Surgical Treatment for Aortic Valve Disease
• Intervention / Treatment: Other: TriRec; Other: Aortic valve replacement

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Markus Krane, MD, PhD; Phone Number: 4111 +4989-1218; Email: krane@dhm.mhn.de

Study Locations

• Germany
  • Bayern
    • Munich, Bayern, Germany, 80336
      • Recruiting
      • Department of Cardiovascular Surgery, German Heart Center Munich
      • Contact: Markus Krane, MD, PhD; Phone Number: -4111 +4989-1218; Email: krane@dhm.mhn.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective orifice area	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	10th postoperative day +/- 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective orifice area	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	after 6 months, 1 year and thereafter annually until the 10th postoperative year
Maximum and mean aortic pressure gradients		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Estimation of aortic regurgitation, if applicable		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Left ventricular ejection fraction		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Left ventricular endsystolic and -diastolic diameter		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Left ventricular endsystolic and -diastolic volume		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Left atrial diameter		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Freedom from aortic valve reintervention at discharge		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Freedom from Mortality		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Freedom from Stroke		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Freedom from Myocardial infarction		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Freedom from conduction disturbances leading to permanent pacemaker implantation		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Freedom from Endocarditis		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Freedom from Bleeding requiring re-thoracotomy		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Collaborators: Department of Cardiovascular Surgery, German Heart Center Munich
• Investigators: Study Chair: Markus Krane, MD, PhD, Department of Cardiovascular Surgery, German Heart Center Munich

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 18, 2018
• Primary Completion (ANTICIPATED): January 1, 2020
• Study Completion (ANTICIPATED): January 1, 2030

Study Registration Dates

• First Submitted: May 30, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (ACTUAL): July 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: aortic stenosis; aortic regurgitation; Trileaflet reconstruction of the aortic valve; Biological aortic valve prosthesis; Effective orifice area
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: 389/17S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No