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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| Duke University | OTHER |
| Massachusetts General Hospital | OTHER |
| Augusta University |
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The purpose of this study is to show that CRT(Cardiac Resynchronization Therapy) pacing in patients with severe functional MR (Mitral Regurgitation) who are not currently indicated for CRT will demonstrate chronic benefit of MR reduction( via echo measured MR/LA area and ERO per American Society of ECHO guidelines) and to show that CRT pacing is safe in these patients.
Approximately 50 patients will be randomized, followed and analyzed in this prospective study. Patients who meet all inclusion and no exclusion criteria will be enrolled and implanted with a CRT system. Baseline evaluation, which includes clinical symptom evaluation and an echocardiogram, will be performed at the time of randomization, which should occur as soon after device implant as possible but no later than 2 week post -implant. The baseline echocardiogram should be acquired prior to the device being programmed to the randomized setting. Repeat echocardiograms and scheduled follow-up evaluations will be performed at the end of each 3 month crossover period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT ON | Other | After implant, patients will be randomized to CRT pacing ON vs OFF in crossover fashion with 3 months in each period |
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| CRT- OFF | Other | After implant, patients will be randomized to CRT pacing OFF vs ON in crossover fashion with 3 months in each period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT pacing | Device | The chronic effect of CRT pacing on the degree of MR in pts with severe-to-moderate or severe functional MR. The treatment being studied is CRT pacing therapy with standard of care LV lead placement. Patients will be randomized to CRT pacing ON vs. OFF and followed for a total of up to 8 months. This includes two 3-month crossover periods for each pacing modality (CRT ON and CRT OFF) and a 6-week washout period between these periods. |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic(8 months post-implant) benefit of MR reduction | To show that CRT pacing in patients with severe functional MR who are not currently indicated for CRT will demonstrate chronic(8 months post-implant) benefit of MR reduction (via echo measured MR/LA area and ERO per American Society of Echo guidelines) | Chronic |
| Measure | Description | Time Frame |
|---|---|---|
| To compare MR Severity (ERO and MR/LA area), heart volume and dimensions via echo and clinical symptoms between two pacing modalities | Secondary objectives will compare MR severity (ERO and MR/LA area), heart volume and dimensions via echo (LA and LV), LVEF via echo (Simpson's method and clinical sypmtoms (NYHA class, QOL, 6MHW distance) between the two pacing modalities (CRT ON and OFF) | Chronic |
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Inclusion Criteria:
Patient is at least 18 years of age
Patients with moderate-to-severe or severe functional MR.
Baseline rates of 50-90 beats per minute (patients with sinus rhythm) or AF
QRS < 120 ms
LVEF < 35%
Willing to sign informed consent
On standard stable heart failure medical regimen (beta blockers and ACE-I or ARBs) for at least 1 month before randomization, if tolerated
Patient has the ability to understand the requirements of the study, including consent for use and disclosure of research-related information
Patient has the ability to comply with study procedures and protocol, including required study visits
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helbert Acosta, MD | Contact | 309-236-0810 | mirbiacosta@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Helbert Acosta, MD | Trinity Medical Center | Principal Investigator |
| Patrick Hranitzky, MD | Duke University | Principal Investigator |
| Jagmeet Singh, MD |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
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| Massachusetts General Hospital |
| Principal Investigator |
| Adam A Berman, MD | Augusta University | Principal Investigator |