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This study will investigate the use of cardiac MRI in patients with standard ICDs and pacemakers to inform how cardiac resynchronization therapy (CRT) can best be implemented in these patient and which patients are the best candidates for CRT.
The scientific premise of this proposal is that left and right ventricular (LV and RV) structural characteristics in patients with existing cardiac implantable electronic devices and heart failure who may benefit from an upgrade to a cardiac resynchronization therapy (CRT) device can be assessed very effectively using cardiac MRI using sequences designed for post-device imaging. Furthermore, a comparative analysis of the differences in LV/RV structural characteristics in patients with existing devices referred for CRT upgrades versus those with de novo CRT implants is expected to be very useful for developing effective strategies for optimal patient selection for CRT upgrades and implementation of CRT upgrades in appropriate patients. Patient selection for CRT upgrades is very important considering that complication rates are higher than in de novo CRT procedures and nonresponse rates are still high. With this in mind, we are performing a study of 100 patients, including 50 prospectively enrolled patients with LVEF less than or equal to 0.35 and New York Heart Association class II-III heart failure, who will be compared with an existing cohort of 50 patients with recent de novo CRT implants, pre-CRT MRIs, and response data. The 50 prospectively enrolled patients having CRT upgrades will undergo a pre-CRT cardiac MRI, pre-CRT/post-CRT echocardiography, and pre-CRT/post-CRT cardiopulmonary exercise testing. In the first aim, we will assess differences in cardiac MRI findings between CRT upgrade patients and de novo CRT patients. In the second aim, we will assess the impact of cardiac MRI findings on LV reverse remodeling and cardiopulmonary capacity in the two groups. In summary, we propose a comprehensive prospective CRT/MRI study in CRT upgrade patients with comparison to a complete MRI dataset of patients with de novo CRT implants in order to identify key differences in MRI findings in these cohorts and the impact of these MRI-based scar and activation findings on clinical outcomes. We expect that our results will have a significant public health impact for patients with heart failure referred for CRT upgrades.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI Prior to CRT for Upgrades | Experimental | MRI will be performed prior to CRT upgrade. |
|
| MRI Prior to de novo CRT Implants | Active Comparator | MRI will be performed prior to de novo CRT implants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI prior to CRT Upgrade | Diagnostic Test | We will perform MRI prior to CRT to inform the optimal CRT implantation strategy in patients with existing devices undergoing upgrades versus those with de novo CRT implants. We will compare outcomes in the two groups. |
| Measure | Description | Time Frame |
|---|---|---|
| CRT Response | CRT Response Based on Change in LVESV After CRT | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Peak Oxygen Consumption | Peak VO2 | 6 months |
| Improvement in Short Form (36) Health Survey | Assesses disability associated with heart failure. We will use the total score, which has a range of 0-100. Lower scores indicate greater disability. |
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Inclusion Criteria:
- Undergoing upgrade from an existing pacemaker or ICD to a CRT device.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kenneth C Bilchick, MD | Contact | 434-924-2465 | bilchick@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kenneth C Bilchick, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Health System | Recruiting | Charlottesville | Virginia | 22901 | United States |
This research will generate MRI, echocardiographic, and cardiopulmonary exercise data in patients referred for CRT upgrades. Examples of specific data fields include the extent/distribution of myocardial scar based on late gadolinium enhancement, characterization of mechanical activation based on MRI strain imaging, baseline MRI volumetric and functional measures, changes in echocardiographic volumes and function resulting from CRT, and changes in cardiopulmonary capacity resulting from CRT.
2 years
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Patients will have cardiac MRI prior to CRT.
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| MRI prior to de novo CRT | Diagnostic Test | We will perform MRI prior to de novo CRT implants as the comparison group. |
|
| 6 months |