TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

• Sponsor: Deutsches Herzzentrum Muenchen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03600662
• Collaborator: Department of Cardiovascular Surgery, German Heart Center Munich (Other)
• Enrollment: 128
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 143.4
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alternative Surgical Treatment for Aortic Valve Disease	Other: TriRec; Other: Aortic valve replacement	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: TriRec - Trileaflet Reconstruction of the Aortic Valve
• Actual Study Start Date: Jan 18, 2018
• Anticipated Primary Completion Date: Jan 1, 2020
• Anticipated Study Completion Date: Jan 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TriRec Trileaflet Reconstruction of the Aortic Valve	Other: TriRec; Trileaflet Reconstruction of the Aortic Valve
Experimental: Aortic valve replacement Biological prosthesis, Device: St. Jude Medical Trifecta GT	Other: Aortic valve replacement; Biological Prosthesis, Device: St. Jude Medical Trifecta GT

Outcome Measures

Primary Outcome Measures

1. Effective orifice area [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 Outcome Measures

1. Effective orifice area [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 [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 [10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year]

4. Left ventricular ejection fraction [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 [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 [10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year]

7. Left atrial diameter [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 [10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year]

9. Freedom from Mortality [10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.]

10. Freedom from Stroke [10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.]

11. Freedom from Myocardial infarction [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 [10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.]

13. Freedom from Endocarditis [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 [10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiovascular Surgery, German Heart Center Munich	Munich	Bayern	Germany	80336

Sponsors and Collaborators

• Deutsches Herzzentrum Muenchen
• Department of Cardiovascular Surgery, German Heart Center Munich

Investigators

• Study Chair: Markus Krane, MD, PhD, Department of Cardiovascular Surgery, German Heart Center Munich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Deutsches Herzzentrum Muenchen
• ClinicalTrials.gov Identifier: NCT03600662
• Other Study ID Numbers: 389/17S
• First Posted: Jul 26, 2018
• Last Update Posted: Jul 26, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Deutsches Herzzentrum Muenchen: aortic stenosis; aortic regurgitation; Trileaflet reconstruction of the aortic valve; Biological aortic valve prosthesis; Effective orifice area
• Additional relevant MeSH terms: Aortic Valve Disease

Study Results

No Results Posted as of Jul 26, 2018