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| ID | Type | Description | Link |
|---|---|---|---|
| 17696 | Other Identifier | REB |
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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.
Objective 1: Using established study data from our previous study (Multimodality imaging Assessment of Pacing InTervention in Heart Failure Heart Failure or MAPIT HF) define characteristics of the "optimal myocardial target" that maximally yields clinical response to CRT.
Objective 2: Using established MAPIT-HF study data identify whether alternate coronary venous pathways to "optimal myocardial targets" exists in clinical non-responders.
Objective 3: Evaluate the feasibility of guiding the delivery of CRT leads to "optimal myocardial targets" through the use of an interactive, 3D "integrated cardiac model" of coronary vein anatomy, myocardial scar and mechanical dyssynchrony.
Currently there is no standard definition for response to CRT. Of importance is that measures of clinical response appear to be incongruent with echocardiographic parameters of reverse remodeling following CRT. The primary endpoint of clinical response will be an improvement in Left ventricular end systolic volume (LVESV) by ≥ 15% at 3 months following CRT, as validated in prior studies. Secondary clinical endpoints will also be evaluated; 1) Improvement in ejection fraction ≥ 5 percentage points, 2) Improvement in 6-minute hall walk ≥ 30 meters or ≥ 10%, 3) Improvement in NYHA (New York Heart Association) functional class by 1, or Specific Activity Score by 1, and 4) Improvement in Quality of Life (Minnesota Living with Heart Failure) by 10 points.
Our hypothesis is that a single 3D dataset can be developed from multiple MRI datasets for the simultaneous display of coronary venous anatomy, myocardial scar, and mechanical dyssynchrony, the latter being derived from tagged MRI data. The investigators hypothesize that the availability of this 3D model during fluoroscopic CRT lead placement will result in improved rates of lead tip delivery to "optimal myocardial targets" and improved clinical response. Our specific hypotheses of Project 2 are as follows;
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Image guided Cardiac Resynchronization Therapy (CRT) device lead placement. | Procedure | 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. | ||
| optimizing myocardial lead placement for Cardiac Resynchronization Therapy (CRT) devices | Procedure | optimal lead placement will be determined by 3D model of coronary vein anatomy, myocardial scar and mechanical dyssynchrony |
| Measure | Description | Time Frame |
|---|---|---|
| improvement in LVESV by greater than/equal to 15% | 3-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James White, MD, FRCPC | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | London | Ontario | N6A5A5 | Canada |
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| 3-6 months |
| improved QoL by 10 points | 3-6 months |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| D004864 | Equipment and Supplies |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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