Health TrialsbyHealthPanel

TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

ConditionAlternative Surgical Treatment for Aortic Valve Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorDeutsches Herzzentrum Muenchen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >= 50 years

Documented symptomatic moderate or greater aortic stenosis or severe insufficiency

Aortic annulus > 19 mm

Written informed consent of the patient.

Disqualifiers

Concomitant intervention of the aortic root

Concomitant intervention of the aortic arch

Concomitant valve surgery

Emergency surgery for any reason

Trial design

Design model

Parallel

Treatments tested in this trial

  • TriRec

    Other intervention

    Trileaflet Reconstruction of the Aortic Valve

  • Aortic valve replacement

    Other intervention

    Biological Prosthesis, Device: St. Jude Medical Trifecta GT

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: TriRecExperimental treatment 1 intervention
Group B: Aortic valve replacementExperimental treatment 1 intervention

Trial outcomes

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

Time frame
10th postoperative day +/- 4 days

Secondary 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

Time frame
after 6 months, 1 year and thereafter annually until the 10th postoperative year
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Deutsches Herzzentrum Muenchen

Lead sponsor

Department of Cardiovascular Surgery, German Heart Center Munich

Collaborator

Source ClinicalTrials.gov
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