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Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing (MODULAR ATP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04798768
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : June 2, 2023
Information provided by (Responsible Party):
Boston Scientific Corporation

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

Condition or disease Intervention/treatment Phase
Tachycardia, Ventricular Arrhythmia, Ventricular Device: mCRM Therapy System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
Actual Study Start Date : July 20, 2021
Estimated Primary Completion Date : February 28, 2025
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Patients implanted with S-ICD and leadless cardiac pacemaker
Patients implanted with an S-ICD and leadless cardiac pacemaker that complete intended testing based on the study protocol
Device: mCRM Therapy System
Communication testing between S-ICD and LCP in 4 body postures as well as required electrical testing.
Other Name: Communication of S-ICD to Leadless Cardiac Pacemaker (LCP)

Primary Outcome Measures :
  1. Safety Endpoint 1 [ Time Frame: Implant through 6 Months Post-Implant ]
    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

  2. Safety Endpoint 2 [ Time Frame: Implant through 12 Months Post-Implant ]

    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

  3. Primary Effectiveness Endpoint 1 [ Time Frame: At the 6 Month Follow-up ]

    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.

  4. Primary Effectiveness Endpoint 2 [ Time Frame: At the 6 Month Follow-up ]

    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

Secondary Outcome Measures :
  1. Secondary Effectiveness Endpoint [ Time Frame: At the 3 Month Visit ]

    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

  2. Secondary Safety Endpoint [ Time Frame: Implant through 2 years post-implant ]
    All-Cause Survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04798768

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Contact: Julie M West 6512615200
Contact: Ursula Appl +32-477-31-92-18

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Sponsors and Collaborators
Boston Scientific Corporation
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Principal Investigator: Michael Lloyd, MD Emory University
Principal Investigator: Reinoud Knops, MD, PhD Amsterdam University Medical Centre
Principal Investigator: Lluis Mont, MD, PhD Hospital Clinic, University of Barcelona
Principal Investigator: Vivek Reddy, MD The Mount Sinai Hospital
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Responsible Party: Boston Scientific Corporation Identifier: NCT04798768    
Other Study ID Numbers: C1907
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: June 2, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD with other researchers in this study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease