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Cardiac Rhythm Management Device

mCRM Therapy System for Ventricular Arrhythmias (MODULAR ATP Trial)

Q: Is this experiment being conducted in multiple healthcare facilities across Canada?

<p>Arrhythmia Research Group in Jonesboro, <a href="https://www.withpower.com/clinical-trials/arkansas">Arkansas</a>, Northwell University Hospital in Manhasset, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> and Cleveland Clinic in <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a> are just a few of the 15 locations participating this clinical trial.</p>

N/A

Waitlist Available

Led By Daniel Cantillon, 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up implant through 2 years post-implant

Awards & highlights

MODULAR ATP Trial 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.Check my eligibility

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.See study design

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.

MODULAR ATP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ implant through 2 years post-implant

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Effectiveness Endpoint 1

Primary Effectiveness Endpoint 2

Safety Endpoint 1

+1 more

Secondary outcome measures

Secondary Effectiveness Endpoint

Secondary Safety Endpoint

MODULAR ATP 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor

718 Previous Clinical Trials

932,651 Total Patients Enrolled

Daniel Cantillon, MDPrincipal InvestigatorThe Cleveland Clinic

Michael Lloyd, MDPrincipal InvestigatorEmory University

1 Previous Clinical Trials

109 Total Patients Enrolled

Media Library

Ventricular Tachycardia Clinical Trial 2023: mCRM Therapy System Highlights & Side Effects. Trial Name: NCT04798768 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment being conducted in multiple healthcare facilities across Canada?

"Arrhythmia Research Group in Jonesboro, Arkansas, Northwell University Hospital in Manhasset, New york and Cleveland Clinic in Ohio are just a few of the 15 locations participating this clinical trial."

Answered by AI

Are there currently any opportunities to join this trial?

"Affirmative. Clinicaltrials.gov records suggest that this clinical trial is actively enrolling participants, commencing on July 20th 2021 and most recently updated November 18th 2022. 300 patients are being recruited across 12 medical centres."

Answered by AI

How many people are currently involved in this medical experiment?

"The Boston Scientific Corporation is responsible for running this trial, which necessitates the enrolment of 300 qualified participants. Different sites are available to join such as Arrhythmia Research Group in Jonesboro, Arkansas and Northwell University Hospital in Manhasset, New york."

Answered by AI