N/A
N=1,173
Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
Ventricular Fibrillation · Ventricular Tachycardia · Low Cardiac Output
Bottom Line
View on ClinicalTrials.gov: NCT02433379 ↗Enrolled (actual)
1,173
Serious AEs
31.7%
Results posted
Jan 2021
Primary outcome: Primary: Percentage of Patients Who Did Not Experience an Inappropriate Shock From Their EMBLEM S-ICD — 95.9 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EMBLEM S-ICD System (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Did Not Experience an Inappropriate Shock From Their EMBLEM S-ICD |
95.9 | — |
| SECONDARY Percentage of Participants Not Experiencing a System or Procedure Related Complication From 0 to 30 Days |
95.8 | — |
| SECONDARY Percentage of Subjects Free From All-cause Shock From Their EMBLEM S-ICD |
90.6 | — |
Summary
This study assesses the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death. Devices are to be programmed with zone cutoffs at 200 bpm and 250 bmp in order to mimic the programming settings for transvenous ICDs in the MADIT RIT study. The incidence of inappropriate S-ICD shocks will be compared to the incidence of inappropriate shocks observed in the MADIT RIT study.
Eligibility Criteria
Inclusion Criteria
- Patient with ischemic or non-ischemic heart disease who meets current guidelines for ICD therapy and intends to undergo a de novo implant procedure for an EMBLEM™ S-ICD (or newer generation BSC S-ICD)
- Left ventricular ejection fraction ≤ 35%
- A passing EMBLEM™ S-ICD (or newer generation BSC S-ICD) screening ECG
- Patient ≥ 21 years of age willing and capable of giving informed consent
- Patient willing and capable of complying with follow-up visits
Exclusion Criteria
- Patient with a history of spontaneous sustained VT or VF
- Patient with bradycardia pacing indication
- Patient eligible and scheduled for cardiac resynchronization implant
- Patient with a previous S-ICD or a previous transvenous pulse generator (pacemaker or defibrillator)
- Patient in NYHA Class IV documented in the medical records within 90 days before enrollment
- Patient with life expectancy shorter than 18 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…)
- Patient receiving hemodialysis within 180 days before to enrollment
- Patients unable to give consent in person, including patients unable to read or write
- Patient who is known to be pregnant or plans to become pregnant over the course of the trial
- Patient unwilling or unable to cooperate with the protocol
- Participation in concurrent clinical study without prior approval from Boston Scientific
- Medical status (e.g., hemodynamic conditions ) of the patient doesn't allow programming devices with a conditional shock zone at 200 bpm and a shock zone at 250 bpm, in the judgment of the implanting physician and/or according to (inter) national guidelines
Data sourced from ClinicalTrials.gov (NCT02433379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.