Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04504188
Status:
RECRUITING
Last Update Posted:
2022-07-13
First Post:
2020-07-31
Brief Title:
Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
Sponsor:
Zoll Medical Corporation
Organization:
Zoll Medical Corporation
Study Overview
Official Title:
Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPT-BB WOMEN
Brief Summary:
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 BBivabradine dosage as compared to a prior historical control
Detailed Description:
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 BBivabradine 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None