Alternative Surgical Treatment for Aortic Valve DiseaseTriRecNCT03600662
TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium
A study testing TriRec and Aortic valve replacement in people with Alternative Surgical Treatment for Aortic Valve Disease, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alternative Surgical Treatment for Aortic Valve Disease
- What is being tested?
- TriRec and Aortic valve replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jan 2018to Jan 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 50 years
- Documented symptomatic moderate or greater aortic stenosis or severe insufficiency
- Aortic annulus > 19 mm
- Written informed consent of the patient.
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Cardiovascular Surgery, German Heart Center Munich
Munich, Bavaria, 80336
Markus Krane, MD, PhD, +4989-1218 ext. -4111, krane@dhm.mhn.de
About this study
Official title: 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.
- Being tested
- TriRec, Aortic valve replacement
- Keywords
- aortic stenosis, aortic regurgitation, Trileaflet reconstruction of the aortic valve, Biological aortic valve prosthesis, Effective orifice area
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriRecOther
Trileaflet Reconstruction of the Aortic Valve
Aortic valve replacementOther
Biological Prosthesis, Device: St. Jude Medical Trifecta GT
| Study group | Role | What they receive |
|---|---|---|
| TriRec | Experimental | Trileaflet Reconstruction of the Aortic Valve Receives: Other: TriRec |
| Aortic valve replacement | Experimental | Biological prosthesis, Device: St. Jude Medical Trifecta GT Receives: Other: Aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10th postoperative day +/- 4 days
Secondary outcomes (14)
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
Measured: after 6 months, 1 year and thereafter annually until the 10th postoperative year
Maximum and mean aortic pressure gradients
Measured: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Estimation of aortic regurgitation, if applicable
Measured: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Left ventricular ejection fraction
Measured: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Left ventricular endsystolic and -diastolic diameter
Measured: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Left ventricular endsystolic and -diastolic volume
Measured: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Left atrial diameter
Measured: 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
Measured: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Freedom from Mortality
Measured: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Freedom from Stroke
Measured: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Freedom from Myocardial infarction
Measured: 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
Measured: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Freedom from Endocarditis
Measured: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Freedom from Bleeding requiring re-thoracotomy
Measured: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start18 Jan 2018
- Primary completionJan 2020 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alternative Surgical Treatment for Aortic Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Cardiovascular Surgery, German Heart Center Munich
- Responsible party
- Sponsor
- Investigators
- Markus Krane, MD, PhD, Study chair, Department of Cardiovascular Surgery, German Heart Center Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600662
- Sponsor's protocol ID
- 389/17S
- Acronym
- TriRec
- Status last verified
- Jul 2018
- First submitted
- 30 May 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No