Actively Recruiting
Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
Led by Zoll Medical Corporation · Updated on 2024-07-24
300
Participants Needed
4
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with newly diagnosed ischemic or non-ischemic cardiomyopathy and an ejection fraction of 35% or less at time of WCD prescription
- Prescribed the WCD for about 90 days (±14 days)
- Used the WCD for no more than 14 days from consent date
- At least 18 years old at time of consent
- After 2 weeks of WCD use, actively wearing it at least 105 hours per week (15 hours per day) to continue in the study
You will not qualify if you...
- Known contraindication or intolerance to beta-blocker therapy
- Permanent atrial fibrillation
- Having a pacemaker
- Having a current or prior implantable cardioverter defibrillator (ICD)
- Self-reporting pregnancy
- Known congenital or inherited heart disease
- Participation in another interventional clinical trial
- Not expected to live longer than 3 months
- Ending WCD use within the first two weeks of use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
TriHealth Hatton Research Institute
Cincinnati, Ohio, United States, 45242
Actively Recruiting
2
Texas Cardiology Associates of Houston
Kingwood, Texas, United States, 77339
Terminated
3
CardioVoyage
McKinney, Texas, United States, 75020
Actively Recruiting
4
CAMC
Charleston, West Virginia, United States, 25304
Terminated
Research Team
M
Mike Osz
CONTACT
T
Tara Roberts
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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