NCT04223713

Brief Summary

This randomized controlled trial was designed to analyze flow patterns in the ascending aorta with MRI after either Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) or surgical valve replacement with biological prosthesis. The hypothesis is that after TriRec procedure more physiological flow patterns will be observed, compared to biological valve prosthesis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 29, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

January 14, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

March 4, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

November 29, 2019

Last Update Submit

March 2, 2021

Conditions

Aortic Valve Disease

Keywords

aortic stenosisaortic regurgitationTrileaflet reconstruction of the aortic valveBiological aortic valve prosthesisaortic flow patternsMRI

Outcome Measures

Primary Outcomes (1)

  • Flow velocity in the ascending aorta (m/s)

    Flow velocity in meters/ second in the ascending aorta in patients receiving either TriRec or biological prosthetic valve replacement measured by 4D- Flow- MRI.

    Day 4-7 post surgery

Secondary Outcomes (11)

  • Flow vortices

    Day 4-7 post surgery

  • Flow helicality

    Day 4-7 post surgery

  • Systolic eccentricity

    Day 4-7 post surgery

  • Flow patterns in the left ventricular outflow tract.

    Day 4-7 post surgery

  • Effective orifice area (4D-Flow-MRI)

    Day 4-7 post surgery

  • +6 more secondary outcomes

Study Arms (2)

TriRec

EXPERIMENTAL

Trileaflet Reconstruction of the Aortic Valve

Procedure: TriRec

Aortic valve replacement

EXPERIMENTAL

Biological prosthesis, Device: Edwards Perimount

Procedure: Aortic valve replacement

Interventions

TriRecPROCEDURE

Trileaflet Reconstruction of the Aortic Valve

TriRec
Aortic valve replacementPROCEDURE

Biological Prosthesis, Device: Edwards Perimount

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 aortic insufficiency
  • Aortic annulus \> 19 mm
  • Written informed consent of the patients.

You may not qualify if:

  • Concomitant intervention of the aortic root, ascending aorta or aortic arch
  • Concomitant valve surgery
  • Emergency surgery for any reason
  • Neurological events (i.e. stroke, TIA) within the previous 6 months
  • Coagulation disorders (including thrombocytopenia \< 100.000/ml)
  • Porcelain aorta/severe calcification of the ascending 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)
  • Contraindication for MRI- examinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum Muenchen, Department of Cardiovascular Surgery

Munich, 80636, Germany

RECRUITING

MeSH Terms

Conditions

Aortic Valve DiseaseAortic Valve StenosisAortic Valve Insufficiency

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Anatol Prinzing, MD

CONTACT

+49891218prinzing@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

November 29, 2019

First Posted

January 10, 2020

Study Start

January 14, 2020

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

March 4, 2021

Record last verified: 2021-01

Locations

DE(1)