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NCT04798768 · ClinicalTrials.gov registry record · NA
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
A NA study of Tachycardia, Ventricular and Arrhythmia, Ventricular, sponsored by Boston Scientific Corporation.
- Active
- Registry status
- NA
- Development phase
- 297
- Enrollment target
- 20
- Study locations
NCT04798768: Active NA study of Tachycardia, Ventricular and Arrhythmia, Ventricular, sponsored by Boston Scientific Corporation.
NCT04798768 is a NA study of Tachycardia, Ventricular and Arrhythmia, Ventricular that is active but no longer recruiting, run by Boston Scientific Corporation. The registered enrollment target is 297 participants, above the 227-participant average among 4 other Tachycardia, Ventricular trials with a reported enrollment target (31% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04798768, a NA study of Tachycardia, Ventricular and Arrhythmia, Ventricular, is active but no longer recruiting, sponsored by Boston Scientific Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 297 participants
- Enrollment target
- 20
- Study locations
Study Summary
The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.
Primary Outcome
Major EMPOWER MPS System- and Procedure-related Complication-Free Rate Subjects will be assessed for safety issues related to the procedure or system through 6 months post implant
Conditions Studied
Interventions
- DEVICE mCRM Therapy System
Study Locations (20)
Ohio
- Cleveland Clinic - Cleveland
- Ohio State University Medical Center - Columbus
- Ohio Health Research Institute - Columbus
Arizona
- Banner University Medical Center Phoenix - Phoenix
- Scottsdale Healthcare - Shea - Scottsdale
New York
- Northwell University Hospital - Manhasset
- Mount Sinai Medical Center - New York
Pennsylvania
- Penn State Health Milton S. Hershey Medical Center - Hershey
- Hospital of the University of Pennsylvania - Philadelphia
Arkansas
- Arrhythmia Research Group - Jonesboro
Florida
- AdventHealth Orlando - Orlando
Georgia
- Emory University Hospital - Atlanta
Kentucky
- Baptist Health Lexington - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 297 participants |
| Start Date | 2021-07-20 |
| Est. Completion | 2030-12-31 |
| Phase | NA |
What the registry record for NCT04798768 still lists
NCT04798768 is an interventional study that assigns participants to a tested intervention. The registered 297 participants enrollment target is mid-sized for trials with a published cap, above the 227-participant average among 4 other Tachycardia, Ventricular trials with a reported enrollment target (31% higher).
The record links to 2 conditions, with Tachycardia, Ventricular appearing as the primary indexed condition, and to 1 intervention - of which mCRM Therapy System is the first listed.
NCT04798768 names 20 study sites across 15 states, led by Ohio, Arizona, New York.
Frequently Asked Questions
What is clinical trial NCT04798768 about?
NCT04798768 is a clinical study titled "Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing". The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.
What is the current status of trial NCT04798768?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 297 participants. The study started on 2021-07-20. Estimated completion is 2030-12-31.
What conditions does trial NCT04798768 study?
This clinical trial studies the following conditions: Tachycardia, Ventricular, Arrhythmia, Ventricular.
What interventions are being tested in trial NCT04798768?
The interventions under investigation include: mCRM Therapy System (DEVICE).
Who is sponsoring clinical trial NCT04798768?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04798768 being conducted?
This trial has 20 study locations across Arizona, Arkansas, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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