Patient Specific Mitral Valve Modeling for Surgical Planning and Training

Mitral Regurgitation Clinical Trial

Official title:

Patient Specific Mitral Valve Modeling for Surgical Planning and Training

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03609931
• Other study ID #: 111462
• Status: Not yet recruiting
• Start date: July 2018
• Est. completion date: January 2020

Study information

• Verified date: July 2018
• Source: Lawson Health Research Institute
• Contact: Daniel Bainbridge, MD FRCPC
• Phone: 5192004235
• Email: daniel.bainbridge[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

BACKGROUND 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. Of this group, approximately 20% have a sufficiently severe form of the disease that may require surgical intervention to restore normal valve function and prevent early mortality [4]. Evidence indicates that the surgeon's individual volume of mitral valve repair cases performed is a determinant of not only successful mitral repair rates, but also freedom from reoperation, and patient survival. For patients previously deemed inoperable due to co-morbidities, new techniques to treat mitral valve disease are being developed. However, assessing the optimal approach and the point at which clinical benefit is exceeded by the poor value or futility of the procedure is one of the biggest clinical challenges for physicians.

In the past decade, 3D echocardiography has emerged as a standard of care in diagnostic and interventional imaging for cardiac surgery and cardiology. This, coupled with the emergence of inexpensive 3D printing technology has led researchers and clinicians to explore how improved imaging and additive manufacturing can be used to improve patient outcomes.

In this context, the investigators have completed a proof-of-concept workflow for creating dynamic, patient specific mitral valve models. In concert with a left ventricle simulator 8], these valve models can mimic patient valve pathologies both anatomically and dynamically, as shown in Doppler ultrasound. In a 10 patient retrospective study, the investigators have demonstrated the ability to accurately re-create patient pathology, perform realistic surgical repairs, and assess realistic valve function post repair. The study team's vision is to create a simulator that can be used to assess patient candidacy for percutaneous interventions, assess different repair options for both percutaneous and surgical interventions, and finally use the model as a simulator for competency-based MV interventions.

RATIONALE Based on our successful proof of concept, the goal is to translate this technology to clinical use by validating our valve models. There are two primary long term goals. First, to validate a system for using patient specific MV models to: 1- assess intervention options, and 2: plan repair strategies for improved patient outcomes. Second, by building a database of MV pathologies, create a competency based simulator/trainer to provide surgeons with increased experience in MV repair techniques.

OBJECTIVES

1. Validate the accuracy of patient specific MV pathologies and repairs in a prospective 65 patient study;

2. Optimize our work-flow for creating valve models, in terms of accuracy, manufacture time required, and expense;

3. Validate the accuracy of our patient models for both surgical cases and transcatheter MitraClip interventions;

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 65
• Est. completion date: January 2020
• Est. primary completion date: August 2019
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergo mitral valve repair with either surgery of MitraClip techniques

• Over 18 years old

Exclusion Criteria:

• Unable to place TEE probe

• Refuse consent

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Disease
• Mitral Valve Insufficiency
• Mitral Valve Prolapse
• Prolapse

Intervention

Procedure:
• Mitral Valve Model
Creation of a mitral valve patient specific model to see if it mimics the patients valve

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2D measurements of the mitral valve: Anterolateral-Posteromedial Diameter	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
Secondary	2D measurements of the mitral valve:Annular Height	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
Secondary	2D measurements of the mitral valve: Annular 3D Circumference	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
Secondary	2D measurements of the mitral valve:Annular 2D Area	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
Secondary	2D measurements of the mitral valve: Annular Ellipticity	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
Secondary	2D measurements of the mitral valve: Anterior Leaflet 3D Area	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
Secondary	2D measurements of the mitral valve: Posterior Leaflet 3D Area	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
Secondary	2D measurements of the mitral valve: Leaflet 3D Area	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
Secondary	2D measurements of the mitral valve: Mitral Regurgitation Orifice Area	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
Secondary	2D measurements of the mitral valve: Tenting Volume	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
Secondary	2D measurements of the mitral valve: Nonplanar Angle	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
Secondary	2D measurements of the mitral valve: tenting Height.	A 2D measurements taken from the echocardiography images of the mitral valve and model	Assessment of model within 1 week of surgical or interventional repair on the patient
Secondary	ICU LOS	length of stay in the ICU	Postoperative period until ICU discharge (expected mean of 1 days)]
Secondary	Hospital LOS	Length of stay in hospital	Postoperative period until hospital discharge (expected mean of 5 days)
Secondary	Delirium	Delirium in hospital	Postoperative period until hospital discharge (expected mean of 5 days)
Secondary	Renal failure requiring dialysis	Dialysis	Postoperative period until hospital discharge (expected mean of 5 days)
Secondary	Stroke,TIA	Diagnosis of stroke	Postoperative period until hospital discharge (expected mean of 5 days)
Secondary	Death in Hospital	Death	Postoperative period until hospital discharge (expected mean of 5 days)
Secondary	Reoperation for Bleeding	Return to the operating room for re-exploration of the surgical procedure due to excess blood loss in the ICU	Postoperative period until hospital discharge (expected mean of 5 days)