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Recruiting

NCT Number: NCT03600662

TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

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.

Recruiting

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Key information

Conditions

Alternative Surgical Treatment for Aortic Valve Disease Aortic Valve Disease Aortic Valve Insufficiency Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiovascular Surgery, German Heart Center Munich

Munich, Bavaria, 80336, Germany

Location status: Recruiting

Location contact

Markus Krane, MD, PhD

CONTACT

[email protected]

+4989-1218 ext. -4111

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TriRec

Other

Trileaflet Reconstruction of the Aortic Valve

Aortic valve replacement

Other

Biological Prosthesis, Device: St. Jude Medical Trifecta GT

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Markus Krane, MD, PhD

CONTACT

[email protected]

+4989-1218 ext. 4111

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Collaborators

  • Department of Cardiovascular Surgery, German Heart Center Munich

Registry information

Official study title

TriRec - Trileaflet Reconstruction of the Aortic Valve

Acronym: TriRec

Important dates

Study start
2018
Primary completion
2020
Study completion
2030
First posted
Jul 26, 2018
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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