mCRM Therapy System for Ventricular Arrhythmias (MODULAR ATP Trial)
Recruiting in Palo Alto (17 mi)
+38 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Boston Scientific Corporation
No Placebo Group
Trial Summary
What is the purpose of this trial?The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.
Eligibility Criteria
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.Exclusion Criteria
My heart rhythm issue is due to a temporary cause.
I am experiencing complications from a heart device infection or its removal.
I am a woman who can have children and I am not pregnant.
I have a blood clot in my heart.
My heart's structure prevents implants in the right ventricle.
I cannot have a large tube inserted into my thigh vein due to my body's structure, recent surgery, or another condition.
Participant Groups
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.
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 Clinic Near You
Research locations nearbySelect from list below to view details:
Institut de Cardiologie de QuebecMontréal, Canada
Banner University Medical Center PhoenixPhoenix, AZ
Scottsdale Healthcare - SheaScottsdale, AZ
Cleveland ClinicCleveland, OH
More Trial Locations
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Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor