Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing

Status: Active_not_recruiting
Location: See all (37) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient who meets Class I, IIa, or IIb guideline ICD indications\[i\],\[ii\], or who has an existing TV-ICD\[iii\] or S-ICD\[iv\]

• Patient who is deemed to be at risk for MVT based on at least ONE of the following:

‣ History of Non-Sustained MVT with LVEF ≤ 50%

⁃ History of sustained VT/VF (secondary prevention) with LVEF ≤ 50% or significant cardiac scar\*

⁃ History of syncope deemed to be arrhythmic in origin

⁃ History of ischemic cardiomyopathy with LVEF ≤35%

⁃ History of non-ischemic cardiomyopathy with LVEF ≤35% and significant scar\*

• Patient who is willing and capable of providing informed consent (which is not to include the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing associated with this investigation at an approved study site and at the intervals defined by this protocol

• Patient who is age 18 years or above, or of legal age to give informed consent specific to state and national law

Locations
United States
Arkansas
Arrhythmia Research Group
Jonesboro
Arizona
Banner University Medical Center Phoenix
Phoenix
Scottsdale Healthcare - Shea
Scottsdale
Florida
AdventHealth Orlando
Orlando
Georgia
Emory University Hospital
Atlanta
Kentucky
Baptist Health Lexington
Lexington
Minnesota
Mayo Clinic
Rochester
New Jersey
Cooper Hospital - University Medical Center
Camden
New York
Northwell University Hospital
Manhasset
Mount Sinai Medical Center
New York
Ohio
Cleveland Clinic
Cleveland
Ohio Health Research Institute
Columbus
Ohio State University Medical Center
Columbus
Pennsylvania
Penn State Health Milton S. Hershey Medical Center
Hershey
Hospital of the University of Pennsylvania
Philadelphia
Tennessee
Erlanger Medical Center
Chattanooga
Virginia
Sentara Norfolk General
Norfolk
Washington
University of Washington Medical Center
Seattle
Other Locations
Austria
Kepler Universitaetsklinikum
Linz
Canada
Institut de Cardiologie de Quebec (Montreal Heart)
Montreal
Institut Universitaire de Cardilogie et Pnuemologie de Quebec (IUCPQ)
Québec
France
CHU Grenoble - Hospital Michallon
Grenoble
CHRU de Lille
Lille
CHU de Nantes-Hopital Laennec
Nantes
Hospital European Georges-Pompidou
Paris
Italy
Spedali Civil di Brescia
Brescia
Maria Cecilia Hospital SPA
Cotignola
AZ Osp Monaldi
Napoli
Azienda Ospedaliero Universitaria Pisana
Pisa
Netherlands
Amsterdam University Medical Center
Amsterdam
St. Antonius Ziekenhuis
Nieuwegein
Erasmus MC University Medical Center
Rotterdam
Spain
Hospital Clinic of Barcelona
Barcelona
United Kingdom
The General Infirmary
Leeds
Liverpool Heart and Chest Hospital
Liverpool
Manchester Heart Center
Manchester
Southampton University Hospital
Southampton
Time Frame
Start Date: 2021-07-20
Completion Date: 2030-12-31
Participants
Target number of participants: 297
Treatments
Experimental: MODULAR ATP Study Participants
All subjects that signed the informed consent were included.~Patients consented to receive the mCRM Therapy System which consists of the EMPOWER Leadless Pacemaker and an EMBLEM S-ICD upgraded with investigational firmware.
Authors
Daniel Cantillon
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov