search
Back to results

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

Primary Purpose

Alternative Surgical Treatment for Aortic Valve Disease

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
TriRec
Aortic valve replacement
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alternative Surgical Treatment for Aortic Valve Disease focused on measuring aortic stenosis, aortic regurgitation, Trileaflet reconstruction of the aortic valve, Biological aortic valve prosthesis, Effective orifice area

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Cardiovascular Surgery, German Heart Center MunichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TriRec

Aortic valve replacement

Arm Description

Trileaflet Reconstruction of the Aortic Valve

Biological prosthesis, Device: St. Jude Medical Trifecta GT

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Maximum and mean aortic pressure gradients
Estimation of aortic regurgitation, if applicable
Left ventricular ejection fraction
Left ventricular endsystolic and -diastolic diameter
Left ventricular endsystolic and -diastolic volume
Left atrial diameter
Freedom from aortic valve reintervention at discharge
Freedom from Mortality
Freedom from Stroke
Freedom from Myocardial infarction
Freedom from conduction disturbances leading to permanent pacemaker implantation
Freedom from Endocarditis
Freedom from Bleeding requiring re-thoracotomy

Full Information

First Posted
May 30, 2018
Last Updated
July 16, 2018
Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Department of Cardiovascular Surgery, German Heart Center Munich
search

1. Study Identification

Unique Protocol Identification Number
NCT03600662
Brief Title
TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium
Acronym
TriRec
Official Title
TriRec - Trileaflet Reconstruction of the Aortic Valve
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Department of Cardiovascular Surgery, German Heart Center Munich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alternative Surgical Treatment for Aortic Valve Disease
Keywords
aortic stenosis, aortic regurgitation, Trileaflet reconstruction of the aortic valve, Biological aortic valve prosthesis, Effective orifice area

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TriRec
Arm Type
Experimental
Arm Description
Trileaflet Reconstruction of the Aortic Valve
Arm Title
Aortic valve replacement
Arm Type
Experimental
Arm Description
Biological prosthesis, Device: St. Jude Medical Trifecta GT
Intervention Type
Other
Intervention Name(s)
TriRec
Intervention Description
Trileaflet Reconstruction of the Aortic Valve
Intervention Type
Other
Intervention Name(s)
Aortic valve replacement
Intervention Description
Biological Prosthesis, Device: St. Jude Medical Trifecta GT
Primary Outcome Measure Information:
Title
Effective orifice area
Description
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
Time Frame
10th postoperative day +/- 4 days
Secondary Outcome Measure Information:
Title
Effective orifice area
Description
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
Time Frame
after 6 months, 1 year and thereafter annually until the 10th postoperative year
Title
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.
Title
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
Title
Left ventricular ejection fraction
Time Frame
10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Title
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
Title
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
Title
Left atrial diameter
Time Frame
10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Title
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
Title
Freedom from Mortality
Time Frame
10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Title
Freedom from Stroke
Time Frame
10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Title
Freedom from Myocardial infarction
Time Frame
10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Title
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.
Title
Freedom from Endocarditis
Time Frame
10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Krane, MD, PhD
Phone
+4989-1218
Ext
4111
Email
krane@dhm.mhn.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Krane, MD, PhD
Organizational Affiliation
Department of Cardiovascular Surgery, German Heart Center Munich
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Cardiovascular Surgery, German Heart Center Munich
City
Munich
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Krane, MD, PhD
Phone
+4989-1218
Ext
-4111
Email
krane@dhm.mhn.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

We'll reach out to this number within 24 hrs