mCRM Therapy System for Ventricular Arrhythmias

(MODULAR ATP Trial)

Recruiting at 38 trial locations

Overseen By Ursula Appl

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Must not be taking: Dexamethasone Acetate

Disqualifiers: CIED infection, LA thrombus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

297 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the mCRM Therapy System treatment for ventricular arrhythmias?

The research highlights that implantable cardioverter-defibrillators (ICDs) and catheter ablation are effective in managing life-threatening ventricular arrhythmias, which are components often used in combination therapies for these conditions. This suggests that treatments like the mCRM Therapy System, which may incorporate similar approaches, could be effective in controlling ventricular arrhythmias and preventing sudden cardiac death. ^{1 2 3 4 5}

Is the mCRM Therapy System for Ventricular Arrhythmias safe for humans?

The safety of treatments for ventricular arrhythmias, including those similar to the mCRM Therapy System, has been evaluated in various studies. Adverse reactions to antiarrhythmic drugs are common, with significant reactions occurring in about 29% of patients. Proper maintenance and operation of related devices, like defibrillators, are crucial to prevent adverse incidents. ^{6 7 8 9 10}

How does the mCRM Therapy System treatment for ventricular arrhythmias differ from other treatments?

The mCRM Therapy System for ventricular arrhythmias is unique because it likely involves advanced technology similar to implantable cardioverter defibrillators (ICDs), which are known for their ability to accurately detect and treat dangerous heart rhythms with options like painless pacing and defibrillation. Unlike traditional anti-arrhythmic drugs, these systems can be implanted and offer continuous monitoring and intervention, potentially reducing the risk of sudden cardiac death. ^{11 12 13 14 15}

Research Team

Reinoud Knops, MD, PhD

Principal Investigator

Amsterdam University Medical Centre

Vivek Reddy, MD

Principal Investigator

The Mount Sinai Hospital

Michael Lloyd

Principal Investigator

Emory University

Lluis Mont

Principal Investigator

Hospital Clinic, University of Barcelona

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.

Inclusion Criteria

I am at least 18 years old or of legal age to consent where I live.

You have a specific type of heart condition or have a certain type of implanted device.

Patient who is willing and capable of providing informed consent and participating in all testing associated with this investigation at an approved study site and at the intervals defined by this protocol

Exclusion Criteria

My heart rhythm issue is due to a temporary cause.

I had a heart attack or similar heart issue within the last 40 days.

You have remaining wires from a previous heart device implanted in your heart.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Assessment

Subjects receive the mCRM Therapy System implantation and initial assessment for safety and effectiveness

6 months

Regular visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up visits at 3 and 6 months

Extended Follow-up

Long-term monitoring for safety and effectiveness, including all-cause survival

Up to 2 years

Treatment Details

Interventions

• mCRM Therapy System

Trial Overview 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.

Participant Groups

Group I: Patients implanted with S-ICD and leadless cardiac pacemaker Experimental Treatment 1 Intervention

Patients implanted with an S-ICD and leadless cardiac pacemaker that complete intended testing based on the study protocol

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Findings from Research

The implantable cardioverter defibrillator (ICD) has proven to be more effective than traditional anti-arrhythmic therapies in reducing overall and cardiac mortality in patients at high risk for life-threatening arrhythmias, based on several randomized trials.

Recent advancements in ICD technology allow for more accurate detection of dangerous heart rhythms and offer various therapy options, including painless pacing and low-energy cardioversion, making the implantation process simpler and more efficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implantable cardioverter defibrillator: technology, indications, and impact on cardiovascular survival. Bhatia, A., Cooley, R., Berger, M., et al.[2004]

References

1. Austria pubmed.ncbi.nlm.nih.gov

[Prognosis and management of patients with tachycardial heart arrhythmia ]. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest : the Cardiac Arrest Study Hamburg (CASH). [2023]

3. United States pubmed.ncbi.nlm.nih.gov

New approaches to management of arrhythmias after myocardial infarction. [2007]

4. Japan pubmed.ncbi.nlm.nih.gov

Arrhythmias and sudden death in heart failure. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Ventricular arrhythmia: role of the implantable cardioverter defibrillator and radiofrequency ablation in addition to drugs. [2004]

6. England pubmed.ncbi.nlm.nih.gov

An impaired renal function and advanced heart failure represent independent predictors of the incidence of malignant ventricular arrhythmias in patients with an implantable cardioverter/defibrillator for primary prevention. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of ventricular arrhythmias in early clinical pharmacology trials and potential consequences for later development. [2010]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse reactions to antiarrhythmic drugs during therapy for ventricular arrhythmias. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Maintenance of defibrillators in a state of readiness. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The DATAS rationale and design: a controlled, randomized trial to assess the clinical benefit of dual chamber (DDED) defibrillator. [2007]

11. England pubmed.ncbi.nlm.nih.gov

[Quantitative evaluation of the efficacy of anti-arrhythmia agents in chronic ventricular arrhythmia]. [2017]

12. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous multielectrode basket catheter for endocardial mapping and ablation of ventricular tachycardia in the pig. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

The implantable cardioverter defibrillator: technology, indications, and impact on cardiovascular survival. [2004]

14. Germany pubmed.ncbi.nlm.nih.gov

[New aspects of defibrillator therapy]. [2006]

15. Italy pubmed.ncbi.nlm.nih.gov

Magnetocardiography: current status and perspectives. Part II: Clinical applications. [2008]