mCRM Therapy System for Ventricular Arrhythmias (MODULAR ATP Trial)

Recruiting in Palo Alto (17 mi)

+38 other locations

Vivek Reddy, MD - Physician's Channel ...

Reinoud Knops M.D. PhD - Full Professor ...

Overseen ByLluis Mont

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