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Cardiac Rhythm Management Device

mCRM Therapy System for Ventricular Arrhythmias (MODULAR ATP Trial)

N/A
Waitlist Available
Led By Vivek Reddy, MD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Patient with a ventricular arrhythmia due to a reversible cause
Patient with an ongoing complication due to Cardiac Implantable Electronic Device (CIED) infection or CIED explant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up implant through 2 years post-implant
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new heart device to see if it is safe and effective.

Who is the study for?
This trial is for adults at risk for rapid heartbeat conditions like MVT, with a history of heart issues or significant cardiac scar. They must be able to consent and follow the study schedule. Exclusions include patients with certain heart anatomies, device complications, pacemaker dependence, recent acute coronary syndrome, known allergies to device materials or drugs used in the study.
What is being tested?
The EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD are being tested for safety and effectiveness in managing ventricular arrhythmias by communicating antitachycardia pacing (ATP). The mCRM Therapy System aims to treat rapid heartbeats without needing wires inside the heart.
What are the potential side effects?
Potential side effects may include reactions related to implantation such as infection or bleeding, inappropriate shocks from the device if it misinterprets heart rhythm, discomfort at the implant site, and possible allergic reactions to system components.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart rhythm issue is due to a temporary cause.
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I am experiencing complications from a heart device infection or its removal.
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I am a woman who can have children and I am not pregnant.
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I have a blood clot in my heart.
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My heart's structure prevents implants in the right ventricle.
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I cannot have a large tube inserted into my thigh vein due to my body's structure, recent surgery, or another condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~implant through 2 years post-implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and implant through 2 years post-implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Effectiveness Endpoint 1
Primary Effectiveness Endpoint 2
Safety Endpoint 1
+1 more
Secondary study objectives
Secondary Effectiveness Endpoint
Secondary Safety Endpoint

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients implanted with S-ICD and leadless cardiac pacemakerExperimental Treatment1 Intervention
Patients implanted with an S-ICD and leadless cardiac pacemaker that complete intended testing based on the study protocol

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
744 Previous Clinical Trials
857,506 Total Patients Enrolled
Vivek Reddy, MDPrincipal InvestigatorThe Mount Sinai Hospital
34 Previous Clinical Trials
12,653 Total Patients Enrolled
Lluis Mont, MD, PhDPrincipal InvestigatorHospital Clinic, University of Barcelona
1 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

Nonsustained Ventricular Tachycardia Clinical Trial 2023: mCRM Therapy System Highlights & Side Effects. Trial Name: NCT04798768 — N/A
~20 spots leftby Mar 2025
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