N/A
N=2,595
Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
Sudden Cardiac Death
Bottom Line
View on ClinicalTrials.gov: NCT02923726 ↗Enrolled (actual)
2,595
Serious AEs
48.2%
Results posted
Oct 2024
Primary outcome: Primary: All-Cause Shock — 129; 178 Participants — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Arm 1 (ATP+Shock) (Device); Arm 2 (shock only) (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-Cause Shock |
129; 178 | 0.005 sig |
| SECONDARY All-Cause Shock or Death From Any Cause |
297; 322 | 0.284 |
| SECONDARY Appropriate Shock |
96; 132 | 0.020 sig |
| SECONDARY Inappropriate Shock |
40; 62 | 0.033 sig |
| SECONDARY All Cause Mortality |
196; 174 | 0.184 |
Summary
The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for implantable cardioverter-defibrillator (ICD) therapy and programmed according to current guidance of higher rate cut-offs and therapy delays. The time to first all-cause shock will be tested in subjects with standard therapy (ATP and shocks) compared to subjects programmed to shock only to assess equivalency.
Eligibility Criteria
Inclusion Criteria
- Subject with a Boston Scientific transvenous ICD (de novo implant or upgrade from pacemaker to ICD) implanted because of one of the following:
- Prior myocardial infarction (MI) and left ventricular ejection fraction (LVEF) ≤ 30% OR
- Ischemic or non-ischemic cardiomyopathy, and LVEF ≤ 35%, and a New York Heart Association (NYHA) class II or III
- Subject is age 21 or above, or is considered of legal age per given geography
- Subject is willing and capable of providing informed consent
- Subject is willing and capable of complying with follow-up visits as defined by this protocol
Exclusion Criteria
- History of spontaneous sustained Ventricular Tachycardia (VT) (≥ 160 bpm at ≥ 30 seconds in duration) or Ventricular Fibrillation (VF) not due to a reversible cause
- NYHA Class IV documented in the medical records within 90 calendar days prior to enrollment
- Subject is eligible and scheduled for cardiac resynchronization (CRT) implant
- Subjects with a previous subcutaneous ICD (S-ICD)
- Subject with existing transvenous ICD (TV-ICD) device implanted for greater than 60 days
- Subjects with coronary artery bypass graft surgery or percutaneous coronary intervention within the past 90 calendar days prior to enrollment
- Subjects with documented myocardial infarction within the past 90 calendar days prior to enrollment
- Subjects on the active heart transplant list
- Subject who has a ventricular assist device (VAD) or is to receive a VAD
- Life expectancy shorter than 18 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…)
- Subjects currently requiring hemodialysis
- Subject who is known to pregnant or plans to become pregnant over the course of the trial
- Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
Data sourced from ClinicalTrials.gov (NCT02923726). 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.