NCT03600662

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
45mo left

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jan 2018Jan 2030

Study Start

First participant enrolled

January 18, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Expected
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

May 30, 2018

Last Update Submit

July 16, 2018

Conditions

Alternative Surgical Treatment for Aortic Valve Disease

Keywords

aortic stenosisaortic regurgitationTrileaflet reconstruction of the aortic valveBiological aortic valve prosthesisEffective orifice area

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Effective orifice area

    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

  • +9 more secondary outcomes

Study Arms (2)

TriRec

EXPERIMENTAL

Trileaflet Reconstruction of the Aortic Valve

Other: TriRec

Aortic valve replacement

EXPERIMENTAL

Biological prosthesis, Device: St. Jude Medical Trifecta GT

Other: Aortic valve replacement

Interventions

TriRecOTHER

Trileaflet Reconstruction of the Aortic Valve

TriRec
Aortic valve replacementOTHER

Biological Prosthesis, Device: St. Jude Medical Trifecta GT

Aortic valve replacement

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiovascular Surgery, German Heart Center Munich

Munich, Bavaria, 80336, Germany

RECRUITING

MeSH Terms

Conditions

Aortic Valve StenosisAortic Valve Insufficiency

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Markus Krane, MD, PhD

    Department of Cardiovascular Surgery, German Heart Center Munich

    STUDY CHAIR

Central Study Contacts

Markus Krane, MD, PhD

CONTACT

+4989-1218krane@dhm.mhn.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2018

First Posted

July 26, 2018

Study Start

January 18, 2018

Primary Completion

January 1, 2020

Study Completion (Estimated)

January 1, 2030

Last Updated

July 26, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)