mCRM Therapy System for Ventricular Arrhythmias

(MODULAR ATP Trial)

Not currently recruiting at 39 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new heart device system called the mCRM Therapy System. Designed for individuals with certain heart rhythm problems, it aims to help manage these issues. Participants must have a history of specific heart conditions, such as ongoing irregular heart rhythms or heart muscle damage, that might pose a risk. Those with heart rhythm issues and related symptoms affecting daily life may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to the development of innovative heart treatments.

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 prior data suggests that the mCRM Therapy System is safe for ventricular arrhythmias?

Research has shown that the mCRM Therapy System is safe for people. In a recent study, 97.5% of patients experienced no major problems after implantation, indicating a smooth experience for nearly all participants. Additionally, the system successfully communicated 98.8% of the time, demonstrating reliable performance. These results suggest that the mCRM Therapy System is well-tolerated and safe for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mCRM Therapy System because it offers a unique approach to treating ventricular arrhythmias. Unlike traditional implantable cardioverter-defibrillators (ICDs) and pacemakers, which often involve transvenous leads, the mCRM system uses an innovative combination of the EMPOWER Leadless Pacemaker and an EMBLEM Subcutaneous ICD (S-ICD) with upgraded investigational firmware. This leadless design reduces the risk of lead-related complications and infections, offering a minimally invasive solution for patients. Additionally, the investigational firmware upgrade enhances the system's ability to respond to abnormal heart rhythms, potentially improving patient outcomes and quality of life.

What evidence suggests that the mCRM Therapy System is effective for ventricular arrhythmias?

Research has shown that the mCRM Therapy System, which participants in this trial will receive, holds promise for treating irregular heartbeats known as ventricular arrhythmias. Studies have found that the system's components communicate successfully 98.8% of the time, which is crucial for effective treatment. Additionally, 97.5% of patients experience no complications after system implantation, indicating its safety. The EMPOWER leadless pacemaker, a component of this system, effectively provides the necessary heart pacing. These findings suggest that the mCRM Therapy System could be a good option for managing ventricular arrhythmias. ^{1 2 3 6 7}

Who Is on the Research Team?

Vivek Reddy, MD

Principal Investigator

The Mount Sinai Hospital

Reinoud Knops, MD, PhD

Principal Investigator

Amsterdam University Medical Centre

Lluis Mont

Principal Investigator

Hospital Clinic, University of Barcelona

Michael Lloyd

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: MODULAR ATP Study Participants Experimental Treatment 1 Intervention

All subjects that signed the informed consent were included. Patients consented to receive the mCRM Therapy System which consists of the EMPOWER Leadless Pacemaker and an EMBLEM S-ICD upgraded with investigational firmware.

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

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10373150/

Design and rationale of the MODULAR ATP global clinical ... Efficacy endpoints are that at 6 months mCRM communication success is significantly higher than 88% and the percentage of subjects with low and stable ...

2. news.bostonscientific.com news.bostonscientific.com/2024-05-18-MODULAR-ATP-Study-of-the-mCRM-TM-System-Meets-Primary-Safety-and-Efficacy-Endpoints

MODULAR ATP Study of the mCRM™ System Meets ... MODULAR ATP study of the mCRM™ System meets primary safety and efficacy endpoints · A major complication-free rate of 97.5% after implantation of ...

3. bostonscientific.com bostonscientific.com/content/dam/bostonscientific/Rhythm%20Management/portfolio-group/EMBLEM_S-ICD/07_Clinical_Data/MODULAR%20ATP%20Customer%20Technology%20and%20Data%20Presentation.pdf

First Results of The Modular ATP Trial The 6-month results of the MODULAR ATP trial demonstrate that the EMPOWER LP is effective in providing VVIR pacing in the first ATP-capable ...

4. dicardiology.com dicardiology.com/content/modular-atp-study-mcrm-system-meets-primary-safety-and-efficacy-endpoints

MODULAR ATP Study of the mCRM System Meets Primary ... A major complication-free rate of 97.5% after implantation of the EMPOWER LP. · A communication success rate of 98.8% from the EMBLEM S-ICD ...

5. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(22)00094-7/fulltext

Long-term performance of a novel communicating ... Long-term mCRM system performance. Communication between the S-ICD and the LP (baseline: n = 38) was successful in 1022 of 1024 attempts (99.8%) ...

6. bostonscientific.com bostonscientific.com/en-US/products/defibrillators/emblem-s-icd-system/clinical-data/appraise-modular-trials.html

APPRAISE, MODULAR Trials - EMBLEM MRI S-ICD System With 162 patients implanted, the mCRM System achieved all pre-specified safety and effectiveness 6-month endpoints from the MODULAR ATP trial. These results ...

7. prnewswire.com prnewswire.com/news-releases/modular-atp-study-of-the-mcrm-system-meets-primary-safety-and-efficacy-endpoints-302149475.html

MODULAR ATP Study of the mCRM™ System Meets ... A major complication-free rate of 97.5% after implantation of the EMPOWER LP. · A communication success rate of 98.8% from the EMBLEM S-ICD ...