Patient Specific Mitral Valve Modeling for Surgical Planning and Training

NCT03609931 | Unknown

• 1 other identifier: 111462
• Study Type: observational
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief Summary

Mitral valve disease is a common pathologic problem occurring in approximately 2% of the general population but climbing to 10% in those over the age of 75 in Canada\[1\]. This project has three primary goals all of which will positively affect cardiac patient care. 1\) Create patient specific MV models for complex repairs that will allow surgeons the opportunity to practice the repair. 2) Potentially predict the outcomes following minimally invasive repair techniques such as transcatheter treatments (e.g., MitraClip). 3) Provide a model to train individuals on mitral valve repair techniques.

Conditions

Mitral Valve Prolapse; Mitral Regurgitation; Mitral Valve Disease

Keywords

Mitral Valve

Outcome Measures

Primary Outcomes (1)

• MR following patient/model repair

  The degree and location of residual MR following mitral repair surgery

  Creation and assessment of the model within 1 week before or after surgery/intervention on the patient.

Secondary Outcomes (19)

• 2D measurements of the mitral valve: Anterolateral-Posteromedial Diameter

  Assessment of model within 1 week of surgical or interventional repair on the patient

• 2D measurements of the mitral valve:Annular Height

  Assessment of model within 1 week of surgical or interventional repair on the patient

• 2D measurements of the mitral valve: Annular 3D Circumference

  Assessment of model within 1 week of surgical or interventional repair on the patient

• 2D measurements of the mitral valve:Annular 2D Area

  Assessment of model within 1 week of surgical or interventional repair on the patient

• 2D measurements of the mitral valve: Annular Ellipticity

  Assessment of model within 1 week of surgical or interventional repair on the patient

Study Arms (1)

Mitral Valve repair

Patients undergoing mitral valve repair

Procedure: Mitral Valve Model

Interventions

Mitral Valve Model PROCEDURE

Creation of a mitral valve patient specific model to see if it mimics the patients valve

Mitral Valve repair

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with mitral regurgitation scheduled to undergo mitral valve repair with either a open heart surgical technique or with a MitraClip

You may qualify if:

• Patients undergo mitral valve repair with either surgery of MitraClip techniques
• Over 18 years old

You may not qualify if:

• Unable to place TEE probe
• Refuse consent

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Related Publications (1)

• Ginty O, Moore J, Peters T, Bainbridge D. Modeling Patient-Specific Deformable Mitral Valves. J Cardiothorac Vasc Anesth. 2018 Jun;32(3):1368-1373. doi: 10.1053/j.jvca.2017.09.005. Epub 2017 Sep 7.

  PMID: 29221976 BACKGROUND

MeSH Terms

Conditions

Mitral Valve Prolapse; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Prolapse; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Daniel Bainbridge, MD FRCPC

CONTACT

5192004235; daniel.bainbridge@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: August 1, 2018
• Study Start: July 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: January 1, 2020
• Last Updated: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share