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NCT03203629 · ClinicalTrials.gov registry record
Heart Sounds Registry
A clinical trial of Heart Failure; With Decompensation, sponsored by Zoll Medical Corporation.
- Completed
- Registry status
- 705
- Enrollment target
- 20
- Study locations
NCT03203629: Completed study of Heart Failure; With Decompensation, sponsored by Zoll Medical Corporation.
NCT03203629 is a study of Heart Failure; With Decompensation that has completed, run by Zoll Medical Corporation. The registered enrollment target is 705 participants, below the 953-participant average among 3 other Heart Failure; With Decompensation trials with a reported enrollment target (26% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03203629, a study of Heart Failure; With Decompensation, has completed, sponsored by Zoll Medical Corporation.
- COMPLETED
- Registry status
- 705 participants
- Enrollment target
- 20
- Study locations
Study Summary
To conduct a prospective, observational study to evaluate the non-interventional feasibility of using heart sounds measurements recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD) for monitoring clinical evidence of heart failure decompensation.
Primary Outcome
Observe the changes in the heart sounds measurement (recorded by the WCD) with clinical evidence of heart failure decompensation during the three month WCD treatment period.
Conditions Studied
Interventions
- DEVICE Wearable Cardioverter Defibrillator (WCD)
Study Locations (20)
Michigan
- Cardiovascular Institute of Michigan - Clinton Township
- Genesys Regional Medical Center - Grand Blanc
- Sparrow Clinical Research Institute - Lansing
- Michigan CardioVascular Institute - Saginaw
Florida
- JFK Medical Center - Atlantis
- Holy Cross Hospital - Fort Lauderdale
- Northside Hospital / Heart Institute - St. Petersburg
Other
- Medizinische Universität Graz - Graz
- Charité Berlin Benjamin Franklin - Berlin
- Herzzentrum Dresden - Dresden
New Jersey
- Virtua The Cardiology Group - Moorestown
- Virtua The Cardiology Group - Voorhees Township
South Carolina
- MD First Research - Anderson
- McLeod Regional - Florence
California
- MD Strategies Research Center - National City
Illinois
- Carle Foundation Hospital - Urbana
Indiana
- FRANCISCAN HEALTH Indianapolis - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 705 participants |
| Start Date | 2017-06-05 |
| Est. Completion | 2021-03-16 |
What the finished NCT03203629 record still lists
NCT03203629 is an observational study that tracks outcomes without assigning an intervention. The registered 705 participants enrollment target is mid-sized for trials with a published cap, below the 953-participant average among 3 other Heart Failure; With Decompensation trials with a reported enrollment target (26% lower).
The record links to 1 condition, with Heart Failure; With Decompensation appearing as the primary indexed condition, and to 1 intervention - of which Wearable Cardioverter Defibrillator (WCD) is the first listed.
NCT03203629 names 20 study sites across 11 states, led by Michigan, Florida, Other.
Frequently Asked Questions
What is clinical trial NCT03203629 about?
NCT03203629 is a clinical study titled "Heart Sounds Registry". To conduct a prospective, observational study to evaluate the non-interventional feasibility of using heart sounds measurements recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD) for monitoring clinical evidence of heart failure decompensation.
What is the current status of trial NCT03203629?
This trial is currently completed. The enrollment target is 705 participants. The study started on 2017-06-05. Estimated completion is 2021-03-16.
What conditions does trial NCT03203629 study?
This clinical trial studies the following conditions: Heart Failure; With Decompensation.
What interventions are being tested in trial NCT03203629?
The interventions under investigation include: Wearable Cardioverter Defibrillator (WCD) (DEVICE).
Who is sponsoring clinical trial NCT03203629?
This trial is sponsored by Zoll Medical Corporation, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03203629 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Indiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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