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Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
NA trial testing mCRM Therapy System in Tachycardia, Ventricular in 297 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | Boston Scientific Corporation |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 297 |
| Start date | 20 July 2021 |
| Primary completion | 6 May 2024 |
| Estimated completion | 31 December 2030 |
| Sites | 38 locations across France, Italy, Netherlands, Austria, United Kingdom, Canada, United States, Spain |
Boston Scientific Corporation — full company profile →
18 and older, any sex, with Tachycardia, Ventricular or Arrhythmia, Ventricular. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| Interim Analysis Cohort | 97.5 | 92.5 – NA |
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
| Group | Value | 95% CI |
|---|---|---|
| CE Mark Cohort | 98.3 | 93.3 – NA |
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.
| Group | Value | 95% CI |
|---|---|---|
| Interim Analysis Cohort | 98.8 | 97.0 – NA |
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
| Group | Value | 95% CI |
|---|---|---|
| Interim Analysis Cohort | 97.4 | 93.4 – NA |
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
| Group | Value | 95% CI |
|---|---|---|
| Patients Implanted With S-ICD and Leadless Cardiac Pacemaker | 0.96 | 0.91 – 1.02 |
Time frame: Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | MODULAR ATP Study Particip… |
|---|---|---|
| Cardiovascular | Cardiac Disorders | — |
| Cardiovascular | Vascular Disorders | — |
| Non-cardiovascular | Infections and Infestations | — |
| Leadless Cardiac Pacemaker - Procedure | Injury, Poisoning and Procedural Complications | — |
| Non-cardiovascular | Respiratory, Thoracic and Mediastinal Disorders | — |
| Non-cardiovascular | General Disorders | — |
| S-ICD System Therapy | Product Issues | — |
| Non-cardiovascular | Renal and Urinary Disorders | — |
| Cardiovascular | General Disorders | — |
| S-ICD System Procedure | Injury, Poisoning and Procedural Complications | — |
| Non-cardiovascular | Endocrine Disorders | — |
| Non-cardiovascular | Gastrointestinal Disorders | — |
| S-ICD Electrode | Product Issues | — |
| S-ICD Defibrillation and Conversion Testing | Injury, Poisoning and Procedural Complications | — |
| S-ICD System Patient Related | Injury, Poisoning and Procedural Complications | — |
| TV Lead Extraction Procedure | Injury, Poisoning and Procedural Complications | — |
| Non-cardiovascular | Nervous System Disorders | — |
| Modular System (LCP+S-ICD) | Product Issues | — |
| S-ICD PG | Product Issues | — |
| S-ICD System Diagnosis | Product Issues | — |
| Non-cardiovascular | Skin and Subcutaneous Tissue Disorders | — |
| Non-cardiovascular | Blood and Lymphatic System Disorders | — |
| Leadless Cardiac Pacemaker - Right Ventricle - Brady | Product Issues | — |
| Reaction | System | MODULAR ATP Study Particip… |
|---|---|---|
| Cardiovascular | Cardiac Disorders | — |
| S-ICD System Procedure | Injury, Poisoning and Procedural Complications | — |
| Leadless Cardiac Pacemaker - Procedure | Injury, Poisoning and Procedural Complications | — |
| S-ICD System Therapy | Product Issues | — |
| Cardiovascular | General Disorders | — |
| Non-cardiovascular | General Disorders | — |
| Cardiovascular | Vascular Disorders | — |
| S-ICD System Patient Related | General Disorders | — |
| S-ICD System Patient Related | Injury, Poisoning and Procedural Complications | — |
| Modular System (LCP+S-ICD) | Product Issues | — |
| S-ICD PG | Product Issues | — |
| Non-cardiovascular | Endocrine Disorders | — |
| Non-cardiovascular | Gastrointestinal Disorders | — |
| Non-cardiovascular | Infections and Infestations | — |
| Leadless Cardiac Pacemaker - Right Ventricle - Brady | Injury, Poisoning and Procedural Complications | — |
| S-ICD Defibrillation and Conversion Testing | Injury, Poisoning and Procedural Complications | — |
| Non-cardiovascular | Musculoskeletal and Connective Tissue Disorders | — |
| S-ICD Electrode | Product Issues | — |
Most-reported serious reactions: Cardiovascular, Cardiovascular, Non-cardiovascular, Leadless Cardiac Pacemaker - Procedure, Non-cardiovascular, Non-cardiovascular, S-ICD System Therapy, Non-cardiovascular.
Data from ClinicalTrials.gov NCT04798768 adverse events section.
The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.
6 peer-reviewed publications reference this trial (live from Europe PMC):
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Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04798768.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing