Status:
RECRUITING
Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
Lead Sponsor:
Zoll Medical Corporation
Conditions:
Cardiomyopathies
Heart Failure
Eligibility:
FEMALE
18+ years
Phase:
NA
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 cardiomy...
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 cardiomy...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04504188
Start Date
March 8 2021
End Date
December 1 2024
Last Update
July 24 2024
Active Locations (4)
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1
TriHealth Hatton Research Institute
Cincinnati, Ohio, United States, 45242
2
Texas Cardiology Associates of Houston
Kingwood, Texas, United States, 77339
3
CardioVoyage
McKinney, Texas, United States, 75020
4
CAMC
Charleston, West Virginia, United States, 25304