Clinical trial NCT04798768: Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
Official title: Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tachycardia, Ventricular
Arrhythmia, Ventricular
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2021-03-15
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: The MODULAR ATP Clinical Study will enroll subjects with a standard Implantable Cardioverter Defibrillator (ICD) indication applying international practice guidelines, as well as those who already have an implanted S-ICD System and satisfy the inclusion criteria for this study, while not meeting any exclusion criteria. Subjects will be followed for at least 6 months following mCRM Therapy System implantation.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient with an ongoing complication due to Cardiac Implantable Electronic Device (CIED) infection or CIED explant
* Transvenous lead remnants within the heart from a previously implanted CIED (Note: transvenous lead remnants outside the heart (e.g., in the SVC) are allowed)
* Patient with a known LA thrombus
* Patient with a ventricular arrhythmia due to a reversible cause
* Patient indicated for implantation of a dual chamber pacemaker or cardiac resynchronization therapy (CRT)
* Patient with another implanted medical device that could interfere with implant of the leadless pacemaker, such as an implanted inferior vena cava filter or mechanical tricuspid heart valve
* Patient requires rate-responsive pacing therapy
* Patient is entirely pacemaker-dependent (defined as escape rhythm ≤ 30 bpm)
* Patient with Acute Coronary Syndrome (i.e. Acute Myocardial Infarction, Unstable Angina) within 40 days
* Inability to access femoral vein with a 21-French or larger inner diameter introducer sheath due to known anatomy condition, recent surgery, and/ or other relevant condition
* Patient who has an active implanted electronic medical device intended for chronic use concomitantly with the study system, such as a left ventricular assist device (LVAD). Note that a temporary pacing wire is allowed.
* Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA)
* Patient with a known cardiovascular anatomy that precludes implant in the right ventricle
* Patient with a known allergy to any system components
* Patient with a known or suspected intolerance to S-ICD conversion testing, based on physician discretion
* Patient is not likely to have meaningful survival\*\* for at least 12 months (documented or per investigator's discretion)
* Patient is enrolled in any other concurrent study. Co-enrollment into other studies such as observational studies/ registries needs prior written approval by BSC. Local mandatory governmental registries are accepted for co-enrollment without approval by BSC.
* Patient who is a woman of childbearing potential who is known to be pregnant at the time of study enrollment (method of assessment upon investigator's discretion)

  \[i\]Al-Khatib, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. (2018); 138:e272-e391.

\[ii\] 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). European Heart Journal (2015) 36, 2793-2867.

\[iii\] TV-ICD system is expected to be fully explanted during or prior to full Coordinated System implant

\[iv\] Potential subjects with a Model 1010 S-ICD Pulse Generator are only eligible for MODULAR ATP if they are getting upgraded to Model A209, A219 or future BSC S-ICD Pulse Generator; Patients with an existing S-ICD PG subject to the electrical overstress field action are only eligible for MODULAR ATP if they are getting a new BSC Model A209 or A219, or future BSC S-ICD Pulse Generator

\*Significant cardiac scar is defined as a scar involving at least one ventricular myocardial segment (i.e., basal infero-septum) as identified in the official findings of a cMRI, or nuclear viability study, or echo report by the interpreting radiologist/ cardiologist who is not affiliated with the study

\*\*meaningful survival means that a patient has a reasonable quality of life and functional status

Primary outcomes:
measure: Safety Endpoint 1
timeFrame: Implant through 6 Months Post-Implant
measure: Safety Endpoint 2
timeFrame: Implant through 12 Months Post-Implant
measure: Primary Effectiveness Endpoint 1
timeFrame: At the 6 Month Follow-up
measure: Primary Effectiveness Endpoint 2
timeFrame: At the 6 Month Follow-up
Secondary outcomes:
measure: Secondary Effectiveness Endpoint
timeFrame: At the 3 Month Visit
measure: Secondary Safety Endpoint
timeFrame: Implant through 2 years post-implant
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare - Shea
state: Arizona
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Camden
country: United States
facility: Cooper Hospital - University Medical Center
state: New Jersey
city: Manhasset
country: United States
facility: Northwell University Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Norfolk
country: United States
facility: Sentara Norfolk General
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Linz
country: Austria
facility: Kepler Universitaetsklinikum
city: Montreal
country: Canada
facility: Institut de Cardiologie de Quebec (Montreal Heart)
state: Quebec
city: Quebec City
country: Canada
facility: Institut Universitaire de Cardilogie et Pnuemologie de Quebec (IUCPQ)
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Grenoble
country: France
facility: CHU Grenoble - Hospital Michallon
city: Lille
country: France
facility: CHRU de Lille
city: Nantes
country: France
facility: CHU de Nantes-Hopital Laennec
city: Paris
country: France
facility: Hospital European Georges-Pompidou
city: Brescia
country: Italy
facility: Spedali Civil di Brescia
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital SPA
city: Napoli
country: Italy
facility: AZ Osp Monaldi
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus MC University Medical Center
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
city: Leeds
country: United Kingdom
facility: The General Infirmary
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: Manchester
country: United Kingdom
facility: Manchester Heart Center
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
Study officials:
affiliation: Emory University
name: Michael Lloyd, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam University Medical Centre
name: Reinoud Knops, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic, University of Barcelona
name: Lluis Mont, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Mount Sinai Hospital
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: