N/A
N=3,889
Improve Sudden Cardiac Arrest Study
Sudden Cardiac Arrest · Ventricular Arrythmia
Bottom Line
View on ClinicalTrials.gov: NCT02099721 ↗Enrolled (actual)
3,889
Serious AEs
24.4%
Results posted
Oct 2020
Primary outcome: Primary: Time to the First Occurrence of a Ventricular Arrhythmia — 32.5; 18.3 Estimated 24-Month VT-VF Pct of Patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ICD or CRT-D Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to the First Occurrence of a Ventricular Arrhythmia |
32.5; 18.3 | — |
| SECONDARY Mortality |
12.1; 18.3 | < 0.0001 sig |
Summary
The purpose of this study is to demonstrate that primary prevention patients with one or more additional risk factors (1.5 prevention criteria: syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent pre-ventricular contractions (PVCs), and low left ventricular ejection fraction (LVEF)) are at a similar risk of life-threatening ventricular arrhythmias (LTVA) when compared to secondary prevention patients, and would receive similar benefit from an implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy- defibrillator (CRT-D) implant.
Eligibility Criteria
Inclusion Criteria
- Subject has a Class I indication for implantation of an ICD according to the American College of Cardiology (ACC)/American Heart Association(AHA)/Heart Rhythm Society (HRS) or European Society of Cardiology (ESC) Guidelines
- Subject (or subject's legally authorized representative) is willing and able to sign and date the Patient Informed Consent Form.
Exclusion Criteria
- Subject is ≤ 18 years of age
- Subject with any exclusion criteria as required by local law (e.g., age, pregnancy, breast feeding)
- Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader
- Subject has any contraindication for ICD/CRT-D
Data sourced from ClinicalTrials.gov (NCT02099721). 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.