Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy