Image Guided Mapping for Cardiac Pacing Intervention
MAPIT-TOO
Multi-Modality Imaging Assessment for Pacing Interventions in Heart Failure: Targeting Optimal Sites and Outcomes
2 other identifiers
interventional
34
1 country
1
Brief Summary
Patients with heart failure and cardiomyopathy that have been referred for Cardiac Resynchronization Therapy (CRT) will have their CRT devices implanted using an image guided treatment plan for optimal lead delivery. The validation of image-guided CRT lead delivery will significantly advance the field of heart failure therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started May 2011
Typical duration for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 29, 2011
CompletedFirst Posted
Study publicly available on registry
July 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2014
CompletedNovember 6, 2017
November 1, 2017
3.3 years
June 29, 2011
November 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
improvement in LVESV by greater than/equal to 15%
3-6 months
Secondary Outcomes (4)
improvement in ejection fraction greater than or equal to 5%,
3-6 months
improvement in 6 minute walk equal to or greater than 30 meters
3-6 months
improvement in NYHA functional class by 1
3-6 months
improved QoL by 10 points
3-6 months
Interventions
Participants will have a cardiac MRI scan prior to insertion of CRT device and an image guided map will be created to guide placement of Cardiac Resynchronization Therapy (CRT) pacing leads to the most optimal target on the patients heart.
optimal lead placement will be determined by 3D model of coronary vein anatomy, myocardial scar and mechanical dyssynchrony
Eligibility Criteria
You may qualify if:
- any patient (\> or equal to 40 years old) referred for cardiac resynchronization therapy
- New York Heart Association (NYHA) greater than or equal to 2
- ejection fraction \</=35%
- QRS duration \>/=120 msec
- Patient has been on stable heart failure medications for at least 6 weeks and in the investigator's opinion reached optimal medical therapy for treatment of heart failure over the past 6 months
You may not qualify if:
- patients with contraindications to MRI
- recent myocardial infarction within last 6 weeks
- cardiac revascularization procedure within the past 3 months
- glomerular filtration rate (GFR) \</= 30ml/min/m2
- unable to give informed consent
- pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Sciences Centre
London, Ontario, N6A5A5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James White, MD, FRCPC
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2011
First Posted
July 12, 2012
Study Start
May 1, 2011
Primary Completion
August 1, 2014
Study Completion
December 18, 2014
Last Updated
November 6, 2017
Record last verified: 2017-11