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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04504188
Other study ID # 90D0229
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 8, 2021
Est. completion date December 2023

Study information

Verified date July 2022
Source Zoll Medical Corporation
Contact Mike Osz
Phone 412-968-3333
Email mosz@zoll.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 BB/ivabradine dosage, as compared to a prior historical control.


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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 2023
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria for Screening Phase: - Female patients with newly diagnosed (never hospitalized for HF in the last 30 days prior to enrollment) ischemic or non-ischemic cardiomyopathy and an EF = 35% at the time of WCD prescription. - Patients prescribed the WCD for an intended 90 ± 14 days of use. - Patients have used the WCD for no more than 14 days from the day of consent. - Patients 18 years of age or older at the time of consent. 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: - Patients with a known contraindication or intolerance to beta-blocker therapy. - Patients with permanent atrial fibrillation. - Patients who have a pacemaker. - Patients with a current or prior implantable cardioverter defibrillator (ICD). - Patients who are self-reporting to be pregnant. - Patients with known congenital or inherited heart disease. - Patients participating in another interventional clinical trial. - Patients not expected to live longer than 3 months. Exclusion Criteria for Continuation Phase: -Patients ending WCD use within the first two weeks of use.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Heart Rate Monitor Enhanced Treatment Optimization
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.

Locations

Country Name City State
United States CAMC Charleston West Virginia
United States Texas Cardiology Associates of Houston Kingwood Texas
United States CardioVoyage McKinney Texas

Sponsors (1)

Lead Sponsor Collaborator
Zoll Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Change in Average Nighttime Resting Heart Rate Change in Average Nighttime Resting Heart Rate Monitored vs. Historic Heart Rate Control over the course of WCD use. 90 days
Secondary 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
Secondary 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
Secondary 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
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