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Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment (IMMPACT)

Primary Purpose

Congenital Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
3D model of heart
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congenital Heart Disease focused on measuring Congenital Heart Disease (CHD)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over the age of 3 months with CHD HF who are candidates for MCS will be prospectively identified at the participating centers.

Exclusion Criteria:

  • Any CHD-HF patient unable to tolerate a CMR or cardiac CT will be excluded.

Sites / Locations

  • Children's National HospitalRecruiting
  • University of FloridaRecruiting
  • Children's Healthcare of AtlantaRecruiting
  • Lurie Children's HospitalRecruiting
  • University of IowaRecruiting
  • Johns Hopkins
  • Mayo ClinicRecruiting
  • Washington UniversityRecruiting
  • Montefiore Medical Center
  • Columbia UniversityRecruiting
  • Weill Cornell
  • Duke University
  • Cleveland ClinicRecruiting
  • University of Virginia
  • Seattle childrens
  • LaCardio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A - 3D models

Group B - Control

Arm Description

Group A will receive 3-D printed models will be used for pre-VAD planning. For patients in Group A, the surgeon will complete a questionnaire 1) after reviewing 2D imaging data and 2) after reviewing a patient specific 3D model. The investigators primary outcome measure will be an improvement in the clarity of cannula and VAD site demonstration. The investigators hypothesize that the 3D models will more clearly demonstrate the sites of cannula and VAD placement as compared to 2D imaging.

Group B will be the controls and will not receive a 3D model.

Outcomes

Primary Outcome Measures

A change in the clarity of cannula and VAD site demonstration
Change in survey responses regarding clarity of VAD or cannula site placement.
Improvement in cardiopulmonary bypass time
Detecting a change in cardiopulmonary bypass time in patients in the group that used the 3D models for pre-VAD planning.

Secondary Outcome Measures

Full Information

First Posted
March 18, 2019
Last Updated
April 26, 2023
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT03891160
Brief Title
Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment
Acronym
IMMPACT
Official Title
Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this research study is to look at the advantages of using a 3D printed heart model for surgical planning in children who have been diagnosed with Congenital Heart Disease (CHD) and clinical heart failure and will undergo a ventricular assist device (VAD) placement. The investigators want to study the correlation of having a 3D printed model with improvement in patient outcomes and compare those with patients who have had a VAD placement without a 3D model.
Detailed Description
Congenital heart disease (CHD) remains the most common type of major congenital malformation and the leading cause of mortality from birth defects [1-4]. Advances in effective treatment for these lesions have significantly extended the lifespan of affected patients, especially for the most complex subtypes of disease. However, these patients are at higher risk of heart failure (HF) secondary to longer life expectancy. This includes patients with a systemic right ventricle and a single ventricle circulation palliated by a Fontan procedure [5, 6]. HF has been documented in up to 30% of patients with a systemic right ventricle and 40% of patients who have had a Fontan procedure [7]. Ventricular assist devices (VAD) are implanted in patients with HF to improve cardiac output and prolong life. They remain underutilized in patients with CHD and HF in part due to the highly variable anatomy in this population. This is true despite outcomes having been shown to be the same for VAD placement in patients with and without CHD [8-10]. In the absence of VAD placement, however, wait list mortality for patients with CHD is higher than for those patients without CHD [11, 12]. Advances in imaging techniques have allowed early diagnosis of CHD as well as anatomic assessment prior to surgical procedures. Given the significant yet often subtle anatomic differences between CHD patients, it is a substantial challenge to thoroughly depict all of the components of a complex patient's cardiac anatomy in a two dimensional imaging dataset. An innovative technology that is being used with more enthusiasm in the medical field, is three-dimensional (3D) printing. Our research team has previously reported on the best technique that should be used to create 3D printed cardiac models from MRI and the subtypes of complex CHD's for which 3D printing should be utilized [13-16]. 3D printing allows creation of patient specific physical anatomic models from a patient's own imaging data. These models provide a physical guide to patient-specific anatomic features that often make VAD and cannula placement challenging in patients with CHD [17]. Factors such as complex cardiac anatomic malformations, heavy trabeculations or a severely dilated ventricle can distort the usual anatomic landmarks used to identify the best position for cannula placement. Our primary goal is to establish the utility of this advanced imaging technique, which provides a much more comprehensive understanding of complex congenital cardiac anatomy. We hypothesize that 3D printed models will allow more informed preoperative planning with a clearer understanding of the best site for inflow and outflow cannula and VAD placement leading to better surgical preparedness, less operating room time and improved patient outcomes. AIM 1: To assess if a 3D printed cardiac model improves perceived visualization of VAD and cannula placement sites in CHD-HF patients as compared to 2D imaging. We will prospectively enroll CHD-HF patients at multiple centers and randomize to Group A (3D printed models will be used for pre-VAD planning) or Group B (no model-controls). For both Groups, all of the cardiothoracic surgeons at the participating center will complete a questionnaire after reviewing 2D imaging data. For Group A, a survey will also be administered after reviewing a patient specific 3D model. Our primary outcome measure will be better perceived visualization of cannula and VAD sites. We hypothesize that the 3D model will more clearly demonstrate sites of cannula and VAD placement as compared to 2D imaging. AIM 2: To determine if perioperative factors and outcomes improve in CHD-HF patients with use of a 3D printed model versus traditional imaging in VAD placement planning. Clinical characteristics will be collected at time of enrollment including primary diagnosis and indication for VAD. After VAD placement, information regarding the intraoperative and postoperative course will be collected including surgical cardiopulmonary bypass time (CPB) and need for cannula repositioning. Longer CPB increases morbidity and mortality and is associated with intensive care readmission in patients after LVAD placement [18-20]. Our primary measures of improvement will be CPB. We hypothesize that the improved preoperative planning using 3D models will lead to a decrease in CPB time. The skill with which we assess patient specific CHD anatomy for pre-procedural planning must be improved, especially for the most complex patients. To confirm the clinical benefit of 3D printed models in pre-surgical planning and justify their use in routine care, multicenter clinical trials must be conducted. As an expert in the field of 3D imaging in cardiac disease, I am well poised to lead this body of research. My goal is to become well versed in conducting high quality multicenter studies and to become facile in survey tool design through this K23 proposal. I will then design a prospective multicenter study for an independent R01 proposal focused on assessing the utility of 3D models in pre-procedural planning for all complex congenital heart diseases. Investigating and reporting on these findings will result in a paradigm shift in what we consider "standard of care" for advanced imaging offered to our most complex CHD patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Congenital Heart Disease (CHD)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A - 3D models
Arm Type
Experimental
Arm Description
Group A will receive 3-D printed models will be used for pre-VAD planning. For patients in Group A, the surgeon will complete a questionnaire 1) after reviewing 2D imaging data and 2) after reviewing a patient specific 3D model. The investigators primary outcome measure will be an improvement in the clarity of cannula and VAD site demonstration. The investigators hypothesize that the 3D models will more clearly demonstrate the sites of cannula and VAD placement as compared to 2D imaging.
Arm Title
Group B - Control
Arm Type
No Intervention
Arm Description
Group B will be the controls and will not receive a 3D model.
Intervention Type
Other
Intervention Name(s)
3D model of heart
Intervention Description
To assess if a 3D printed cardiac model improves visualization of VAD and cannula placement sites in CHD-HF patients as compared to 2D imaging. The investigators will prospectively enroll CHD-HF patients at multiple centers and randomize to group A (3D printed models will be used for pre-VAD planning) or Group B (controls).
Primary Outcome Measure Information:
Title
A change in the clarity of cannula and VAD site demonstration
Description
Change in survey responses regarding clarity of VAD or cannula site placement.
Time Frame
30 day
Title
Improvement in cardiopulmonary bypass time
Description
Detecting a change in cardiopulmonary bypass time in patients in the group that used the 3D models for pre-VAD planning.
Time Frame
5 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who weigh over 3 kilograms with CHD HF who are candidates for MCS will be prospectively identified at the participating centers. Exclusion Criteria: Any CHD-HF patient unable to tolerate a CMR or cardiac CT will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kanwal Farooqi, MD
Phone
212-305-8509
Email
kf2549@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Katrina Golub, MPH
Phone
212-342-1562
Email
kg2697@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kanwal Farooqi, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves d'Udekem, MD, PhD
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Jacobs, MD
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fawwaz Shaw, MD
Facility Name
Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Monge, MD
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ravi Ashwath, MD
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelby Kutty, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Stulak, MD
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pirooz Eghtesady, MD
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Saeed, MD
First Name & Middle Initial & Last Name & Degree
Ulrich Jorde, MD
First Name & Middle Initial & Last Name & Degree
Omar Saeed, MD
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kanwal Farooqi, MD
Phone
212-342-1562
Email
kf2549@cumc.columbia.edu
Facility Name
Weill Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshifumi Naka, MD
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Turek, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tara Karamlou, MD
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Gangemi, MD
Facility Name
Seattle childrens
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David McMullan, MD
Facility Name
LaCardio
City
Bogotá
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Guerrero, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment

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