mCRM Therapy System for Ventricular Tachycardia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ventricular Tachycardia+1 MoremCRM Therapy System - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new heart device to see if it is safe and effective.

Eligible Conditions
  • Ventricular Tachycardia
  • Ventricular Arrhythmia

Treatment Effectiveness

Study Objectives

4 Primary · 2 Secondary · Reporting Duration: Implant through 2 years post-implant

Month 3
Secondary Effectiveness Endpoint
Month 6
Primary Effectiveness Endpoint 1
Primary Effectiveness Endpoint 2
Month 12
Safety Endpoint 2
Year 2
Secondary Safety Endpoint
Month 6
Safety Endpoint 1

Trial Safety

Trial Design

1 Treatment Group

Patients implanted with S-ICD and leadless cardiac pacemaker
1 of 1

Experimental Treatment

300 Total Participants · 1 Treatment Group

Primary Treatment: mCRM Therapy System · No Placebo Group · N/A

Patients implanted with S-ICD and leadless cardiac pacemaker
Device
Experimental Group · 1 Intervention: mCRM Therapy System · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: implant through 2 years post-implant

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
674 Previous Clinical Trials
915,582 Total Patients Enrolled
Michael Lloyd, MDPrincipal InvestigatorEmory University
1 Previous Clinical Trials
109 Total Patients Enrolled
Reinoud Knops, MD, PhDPrincipal InvestigatorAmsterdam University Medical Centre
Lluis Mont, MD, PhDPrincipal InvestigatorHospital Clinic, University of Barcelona
1 Previous Clinical Trials
70 Total Patients Enrolled
Daniel Cantillon, MDPrincipal InvestigatorThe Cleveland Clinic
Vivek Reddy, MDPrincipal InvestigatorThe Mount Sinai Hospital
30 Previous Clinical Trials
17,967 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a history of non-ischemic cardiomyopathy with LVEF ≤35% and significant scar.
You are 18 years or above, or of legal age to give informed consent specific to state and national law.
You have a history of Non-Sustained VT with LVEF ≤ 50% for more than 2 weeks.
You have ischemic cardiomyopathy with a left ventricular ejection fraction of ≤35%.