An interventional study of Heart Rate Monitor Enhanced Treatment Optimization in Cardiomyopathies and Heart Failure, sponsored by Zoll Medical Corporation. Recruiting at 4 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by Zoll Medical Corporation · Not applicable, Interventional, and Treatment
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.
553 studies on the registry are indexed under Cardiomyopathies; 152 are open to participants now.
This study's planned enrollment of 300 is above the median of 51 across 266 interventional studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Zoll Medical Corporation is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will be continuously monitored by the WCD.
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.
Also known as: LifeVest Wearable Cardioverter Defibrillator
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.
Time frame: 90 days
Heart Rate Control in Ischemic vs. Non-ischemic Patients
To document the percentage achievement in effective HR control in ischemic vs. non-ischemic patients
Time frame: 90 days
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.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 90 days
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2021 (actual). Primary completion is estimated for Sep 2024, 42 months after the start.
Of 51 interventional studies with no phase under Cardiomyopathies, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 52. This study's planned 42 months is close to that.
How these figures are worked out, and which studies are left out of them.
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