Arrhythmia, Ventricular, Tachycardia, Ventricular
Conditions
Brief summary
The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.
Detailed description
The MODULAR ATP Clinical Study will enroll subjects with a standard Implantable Cardioverter Defibrillator (ICD) indication applying international practice guidelines, as well as those who already have an implanted S-ICD System and satisfy the inclusion criteria for this study, while not meeting any exclusion criteria. Subjects will be followed for at least 6 months following mCRM Therapy System implantation.
Interventions
DEVICEmCRM Therapy System
Communication testing between S-ICD and LCP in 4 body postures as well as required electrical testing.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient who meets Class I, IIa, or IIb guideline ICD indications\[i\],\[ii\], or who has an existing TV-ICD\[iii\] or S-ICD\[iv\] * Patient who is deemed to be at risk for MVT based on at least ONE of the following: * History of Non-Sustained MVT with LVEF ≤ 50% * History of sustained VT/VF (secondary prevention) with LVEF ≤ 50% or significant cardiac scar\* * History of syncope deemed to be arrhythmic in origin * History of ischemic cardiomyopathy with LVEF ≤35% * History of non-ischemic cardiomyopathy with LVEF ≤35% and significant scar\* * Patient who is willing and capable of providing informed consent (which is not to include the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing associated with this investigation at an approved study site and at the intervals defined by this protocol * Patient who is age 18 years or above, or of legal age to give informed consent specific to state and national law
Exclusion criteria
* Patient with an ongoing complication due to Cardiac Implantable Electronic Device (CIED) infection or CIED explant * Transvenous lead remnants within the heart from a previously implanted CIED (Note: transvenous lead remnants outside the heart (e.g., in the SVC) are allowed) * Patient with a known LA thrombus * Patient with a ventricular arrhythmia due to a reversible cause * Patient indicated for implantation of a dual chamber pacemaker or cardiac resynchronization therapy (CRT) * Patient with another implanted medical device that could interfere with implant of the leadless pacemaker, such as an implanted inferior vena cava filter or mechanical tricuspid heart valve * Patient requires rate-responsive pacing therapy * Patient is entirely pacemaker-dependent (defined as escape rhythm ≤ 30 bpm) * Patient with Acute Coronary Syndrome (i.e. Acute Myocardial Infarction, Unstable Angina) within 40 days * Inability to access femoral vein with a 21-French or larger inner diameter introducer sheath due to known anatomy condition, recent surgery, and/ or other relevant condition * Patient who has an active implanted electronic medical device intended for chronic use concomitantly with the study system, such as a left ventricular assist device (LVAD). Note that a temporary pacing wire is allowed. * Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA) * Patient with a known cardiovascular anatomy that precludes implant in the right ventricle * Patient with a known allergy to any system components * Patient with a known or suspected intolerance to S-ICD conversion testing, based on physician discretion * Patient is not likely to have meaningful survival\*\* for at least 12 months (documented or per investigator's discretion) * Patient is enrolled in any other concurrent study. Co-enrollment into other studies such as observational studies/ registries needs prior written approval by BSC. Local mandatory governmental registries are accepted for co-enrollment without approval by BSC. * Patient who is a woman of childbearing potential who is known to be pregnant at the time of study enrollment (method of assessment upon investigator's discretion) \[i\]Al-Khatib, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. (2018); 138:e272-e391. \[ii\] 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). European Heart Journal (2015) 36, 2793-2867. \[iii\] TV-ICD system is expected to be fully explanted during or prior to full Coordinated System implant \[iv\] Potential subjects with a Model 1010 S-ICD Pulse Generator are only eligible for MODULAR ATP if they are getting upgraded to Model A209, A219 or future BSC S-ICD Pulse Generator; Patients with an existing S-ICD PG subject to the electrical overstress field action are only eligible for MODULAR ATP if they are getting a new BSC Model A209 or A219, or future BSC S-ICD Pulse Generator \*Significant cardiac scar is defined as a scar involving at least one ventricular myocardial segment (i.e., basal infero-septum) as identified in the official findings of a cMRI, or nuclear viability study, or echo report by the interpreting radiologist/ cardiologist who is not affiliated with the study \*\*meaningful survival means that a patient has a reasonable quality of life and functional status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months | Implant through 6 Months Post-Implant | Major EMPOWER MPS System- and Procedure-related Complication-Free Rate Subjects will be assessed for safety issues related to the procedure or system through 6 months post implant |
| Safety Endpoint 2: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 12 Months | Implant through 12 Months Post-Implant | Major EMPOWER MPS System- and Procedure-related Complication-free Rate Subjects will be assessed for safety issues related to the procedure or system through 12 months post implant |
| Primary Effectiveness Endpoint 1: Percentage of Body Postures With Communication Success Between the S-ICD and EMPOWER PG | At the 6 Month Follow-up | Communication Success between the S-ICD and EMPOWER PG Data from subjects will be assessed for effectiveness of communication between S-ICD and the EMPOWER PG by evaluating if a paced beat is present during communication testing in four postures: upright, supine, and right and left side. |
| Primary Effectiveness Endpoint 2: Percentage of Subjects Classified as a Pacing Capture Threshold (PCT) Responder | At the 6 Month Follow-up | Proportion of Subjects with Adequate Pacing Capture Threshold Effectiveness will be confirmed by evaluating the percentage of subjects considered to be a PCT Responder, defined as a subject with a PCT measurement of ≤ 2.0 V @ 0.4 ms pulse width |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Effectiveness Endpoint: Subject-specific Slope of EMPOWER PG Sensor-Indicated Rate to the Subject's Workload on Treadmill Test | At the 3 Month Visit | Metabolic-Chronotropic Relation Slope (MCR Slope) from the Kay-Wilkoff Model Using the Kay-Wilkoff model, data will be assessed to evaluate the proportionality of the EMPOWER PG's sensor-indicated rate to the subject's workload during the treadmill test |
| Secondary Safety Endpoint | Implant through 2 years post-implant | All-Cause Survival; data not reported as it is still being collected |
Countries
Austria, Canada, Czechia, France, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORMichael Lloyd, MD
Emory University
PRINCIPAL_INVESTIGATORReinoud Knops, MD, PhD
Amsterdam University Medical Centre
PRINCIPAL_INVESTIGATORLluis Mont, MD, PhD
Hospital Clinic, University of Barcelona
PRINCIPAL_INVESTIGATORVivek Reddy, MD
The Mount Sinai Hospital
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MODULAR ATP Study Participants Patients consented to receive the mCRM Therapy System which consists of the EMPOWER Leadless Pacemaker and an EMBLEM S-ICD upgraded with investigational firmware | 297 |
| Total | 297 |
Baseline characteristics
| Characteristic | MODULAR ATP Study Participants |
|---|---|
| Age, Continuous | 59 Years STANDARD_DEVIATION 12 |
| BMI | 29.7 kg/m^2 STANDARD_DEVIATION 6.4 |
| Diabetes | 108 Participants |
| Hyperlipidemia | 181 Participants |
| Ischemic cardiomyopathy | 182 Participants |
| LVEF | 35.3 percent STANDARD_DEVIATION 13.1 |
| Non-ischemic cardiomyopathy | 93 Participants |
| NYHA Classification Class I | 88 Participants |
| NYHA Classification Class II | 146 Participants |
| NYHA Classification Class III | 61 Participants |
| NYHA Classification Class IV | 2 Participants |
| Prevention status Primary Prevention | 170 Participants |
| Prevention status Secondary Prevention | 127 Participants |
| Race/Ethnicity, Customized American Indian or Alaska native | 2 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 23 Participants |
| Race/Ethnicity, Customized Caucasian | 177 Participants |
| Race/Ethnicity, Customized Multiracial | 11 Participants |
| Race/Ethnicity, Customized Not disclosed | 76 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Region of Enrollment Austria | 5 participants |
| Region of Enrollment Canada | 16 participants |
| Region of Enrollment Czechia | 1 participants |
| Region of Enrollment France | 30 participants |
| Region of Enrollment Italy | 15 participants |
| Region of Enrollment Netherlands | 12 participants |
| Region of Enrollment Spain | 20 participants |
| Region of Enrollment United Kingdom | 18 participants |
| Region of Enrollment United States | 180 participants |
| Renal dysfunction | 47 Participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 245 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 18 / 297 |
| other Total, other adverse events | 86 / 288 |
| serious Total, serious adverse events | 113 / 288 |
Outcome results
Primary
Primary Effectiveness Endpoint 1: Percentage of Body Postures With Communication Success Between the S-ICD and EMPOWER PG
Communication Success between the S-ICD and EMPOWER PG Data from subjects will be assessed for effectiveness of communication between S-ICD and the EMPOWER PG by evaluating if a paced beat is present during communication testing in four postures: upright, supine, and right and left side.
Time frame: At the 6 Month Follow-up
Population: Number of subjects in the interim analysis cohort who underwent S-ICD to EMPOWER LP communication testing at 6 months in at least one of four postures. Results were adjusted using a repeated measures logistic regression model
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interim Analysis Cohort | Primary Effectiveness Endpoint 1: Percentage of Body Postures With Communication Success Between the S-ICD and EMPOWER PG | 98.8 Adjusted % with successful communication |
Primary
Primary Effectiveness Endpoint 2: Percentage of Subjects Classified as a Pacing Capture Threshold (PCT) Responder
Proportion of Subjects with Adequate Pacing Capture Threshold Effectiveness will be confirmed by evaluating the percentage of subjects considered to be a PCT Responder, defined as a subject with a PCT measurement of ≤ 2.0 V @ 0.4 ms pulse width
Time frame: At the 6 Month Follow-up
Population: Number of subjects in the interim analysis cohort with Pacing Capture Threshold data at 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interim Analysis Cohort | Primary Effectiveness Endpoint 2: Percentage of Subjects Classified as a Pacing Capture Threshold (PCT) Responder | 97.4 % of subjects with PCT <= 2V @ 0.4 ms |
Primary
Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months
Major EMPOWER MPS System- and Procedure-related Complication-Free Rate Subjects will be assessed for safety issues related to the procedure or system through 6 months post implant
Time frame: Implant through 6 Months Post-Implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interim Analysis Cohort | Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months | 97.5 % of subjects free from complication |
Primary
Safety Endpoint 2: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 12 Months
Major EMPOWER MPS System- and Procedure-related Complication-free Rate Subjects will be assessed for safety issues related to the procedure or system through 12 months post implant
Time frame: Implant through 12 Months Post-Implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interim Analysis Cohort | Safety Endpoint 2: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 12 Months | 98.3 % of subjects free from complication |
Secondary
Secondary Effectiveness Endpoint: Subject-specific Slope of EMPOWER PG Sensor-Indicated Rate to the Subject's Workload on Treadmill Test
Metabolic-Chronotropic Relation Slope (MCR Slope) from the Kay-Wilkoff Model Using the Kay-Wilkoff model, data will be assessed to evaluate the proportionality of the EMPOWER PG's sensor-indicated rate to the subject's workload during the treadmill test
Time frame: At the 3 Month Visit
Population: Data for this endpoint were obtained from the subset of subjects who consented into the substudy and performed treadmill testing at 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Interim Analysis Cohort | Secondary Effectiveness Endpoint: Subject-specific Slope of EMPOWER PG Sensor-Indicated Rate to the Subject's Workload on Treadmill Test | 0.96 Beta coefficient |
Secondary
Secondary Safety Endpoint
All-Cause Survival; data not reported as it is still being collected
Time frame: Implant through 2 years post-implant