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

Tachycardia, Ventricular Clinical Trial

— MODULAR ATP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04798768
• Other study ID #: C1907
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 20, 2021
• Est. completion date: December 31, 2030

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 297
• Est. completion date: December 31, 2030
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia, Ventricular
• Tachycardia
• Tachycardia, Ventricular

Intervention

Device:
• mCRM Therapy System
Communication testing between S-ICD and LCP in 4 body postures as well as required electrical testing.

Locations

Country	Name	City	State
Austria	Kepler Universitaetsklinikum	Linz
Canada	Institut de Cardiologie de Quebec (Montreal Heart)	Montreal	Quebec
Canada	Institut Universitaire de Cardilogie et Pnuemologie de Quebec (IUCPQ)	Quebec City
Czechia	Na Homolce Hospital	Prague
France	CHU Grenoble - Hospital Michallon	Grenoble
France	CHRU de Lille	Lille
France	CHU de Nantes-Hopital Laennec	Nantes
France	Hospital European Georges-Pompidou	Paris
Italy	Spedali Civil di Brescia	Brescia
Italy	Maria Cecilia Hospital SPA	Cotignola
Italy	AZ Osp Monaldi	Napoli
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Netherlands	Amsterdam University Medical Center	Amsterdam
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	Erasmus MC University Medical Center	Rotterdam
Spain	Hospital Clinic of Barcelona	Barcelona
United Kingdom	The General Infirmary	Leeds
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool
United Kingdom	Manchester Heart Center	Manchester
United Kingdom	Southampton University Hospital	Southampton
United States	Emory University Hospital	Atlanta	Georgia
United States	Cooper Hospital - University Medical Center	Camden	New Jersey
United States	Erlanger Medical Center	Chattanooga	Tennessee
United States	Cleveland Clinic	Cleveland	Ohio
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Arrhythmia Research Group	Jonesboro	Arkansas
United States	Baptist Health Lexington	Lexington	Kentucky
United States	Northwell University Hospital	Manhasset	New York
United States	Mount Sinai Medical Center	New York	New York
United States	Sentara Norfolk General	Norfolk	Virginia
United States	AdventHealth Orlando	Orlando	Florida
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Banner University Medical Center Phoenix	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	Scottsdale Healthcare - Shea	Scottsdale	Arizona
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Czechia,  France,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Endpoint 1	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	Implant through 6 Months Post-Implant
Primary	Safety Endpoint 2	Major EMPOWER MPS System- and Procedure-related Complication-free Rate; Subjects will be assessed for safety issues related to the procedure or system through 12 months post implant	Implant through 12 Months Post-Implant
Primary	Primary Effectiveness Endpoint 1	Communication Success between the S-ICD and EMPOWER PG; Data from subjects will be assessed for effectiveness of communication between S-ICD and the EMPOWER PG by evaluating if a paced beat is present during communication testing in four postures: upright, supine, and right and left side.	At the 6 Month Follow-up
Primary	Primary Effectiveness Endpoint 2	Proportion of Subjects with Adequate Pacing Capture Threshold; Effectiveness will be confirmed by evaluating the percentage of subjects considered to be a Pacing Capture Threshold (PCT) Responder, defined as a subject with a PCT measurement of = 2.0 V @ 0.4 ms pulse width	At the 6 Month Follow-up
Secondary	Secondary Effectiveness Endpoint	Metabolic-Chronotropic Relation Slope (MCR Slope) from the Kay-Wilkoff Model; Using the Kay-Wilkoff model, data will be assessed to evaluate the proportionality of the EMPOWER PG's sensor-indicated rate to the subject's workload during the treadmill test	At the 3 Month Visit
Secondary	Secondary Safety Endpoint	All-Cause Survival	Implant through 2 years post-implant