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The primary objective of this pilot study is to document the percentage achievement in effective HR control (average nighttime HR < 70 bpm) during WCD use in a cohort of female patients with cardiomyopathy in an outpatient setting using continuous heart rate (HR) trends data from the WCD to optimize BB/ivabradine dosage, as compared to a prior historical control.
The primary objective of this pilot study is to document the percentage achievement in effective HR control (average nighttime HR < 70 bpm) during WCD use in a cohort of female patients with cardiomyopathy in an outpatient setting using continuous heart rate (HR) trends data from the WCD to optimize BB/ivabradine dosage, as compared to a prior historical control.
Adult female patients (18 years or older) who are prescribed the wearable cardioverter defibrillator (WCD) for 3 months for ischemic or non-ischemic cardiomyopathy with a low ejection fraction.
Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will be continuously monitored by the WCD. Every two weeks a report showing daily HR trends will be emailed to the healthcare provider. The healthcare provider will also receive a HR control alert if the HR exceeds a predetermined threshold for 3 days in a row.
Based on this information, clinicians should follow guideline-directed medical therapy (GDMT) to add or titrate medication accordingly. The goal of these changes will be to achieve the average nighttime HR to recommended guidelines (<70 bpm) by the end of WCD use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Rate Monitor Enhanced Treatment Optimization | Experimental | Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will be continuously monitored by the WCD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart Rate Monitor Enhanced Treatment Optimization | Device | Heart rate (HR) will be continuously monitored by the WCD. Every two weeks a report showing daily HR trends will be emailed to the healthcare provider. The healthcare provider will also receive a HR control alert if the HR exceeds a predetermined threshold for 3 days in a row. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Control | The primary objective of this study is to document the percentage achievement in effective HR control (average nighttime HR < 70 bpm) during WCD use in female patients. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Control in Ischemic vs. Non-ischemic Patients | To document the percentage achievement in effective HR control in ischemic vs. non-ischemic patients | 90 days |
| Change in Average Nighttime Resting Heart Rate |
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Inclusion Criteria for Screening Phase:
Inclusion Criteria for Continuation Phase:
-After the first 2 weeks of WCD wear, only actively wearing patients averaging at least 105 hours of WCD wear per week (or 15 hours/day) are eligible to continue.
Exclusion Criteria for Screening Phase:
Exclusion Criteria for Continuation Phase:
-Patients ending WCD use within the first two weeks of use.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mike Osz | Contact | 412-968-3333 | mosz@zoll.com | |
| Tara Roberts | Contact | 412-968-3333 | tara.roberts@zoll.com |
| Name | Affiliation | Role |
|---|---|---|
| Valentina Kutyifa, MD PHD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TriHealth Hatton Research Institute | Recruiting | Cincinnati | Ohio | 45242 | United States |
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| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will be continuously monitored by the WCD. Every two weeks a report showing daily HR trends will be emailed to the healthcare provider. The healthcare provider will also receive a HR control alert if the HR exceeds a predetermined threshold for 3 days in a row.
Based on this information, clinicians should follow guideline-directed medical therapy (GDMT) to add or titrate medication accordingly. The goal of these changes will be to achieve the average nighttime HR to recommended guidelines (<70 bpm) by the end of WCD use.
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|
Change in Average Nighttime Resting Heart Rate Monitored vs. Historic Heart Rate Control over the course of WCD use.
| 90 days |
| Changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) | To observe changes in quality of life over the course of WCD use using the KCCQ-12 Questionnaire. Higher scores on the KCCQ reflect better health status (range 0-100) | 90 days |
| Changes in (European Quality of Life 5 Dimension Questionnaire (EQ-5D-5L) | To observe changes in quality of life over the course of WCD use using the EQ-5D-5L Questionnaire. Higher scores on the EQ-5D-5L reflect better health status (range 0-100) | 90 days |
| Changes in Functional Capacity | To observe changes in functional capacity as measured by average daily step count over the course of WCD use. | 90 days |
| Texas Cardiology Associates of Houston | Terminated | Kingwood | Texas | 77339 | United States |
| CardioVoyage | Recruiting | McKinney | Texas | 75020 | United States |
|
| CAMC | Terminated | Charleston | West Virginia | 25304 | United States |