Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fr… (NCT02433379) | Clinical Trial Compass
CompletedNot Applicable
Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
United States, Belgium, Canada1,173 participantsStarted 2015-06-09
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 devic…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Patients Who Did Not Experience an Inappropriate Shock From Their EMBLEM S-ICD