CompletedNot Applicable

Improve Sudden Cardiac Arrest Study

Argentina, Belarus4,222 participantsStarted 2014-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time to the First Occurrence of a Ventricular Arrhythmia

Timeframe: Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month VT-VF rate (as compared in the Outcome Measure table between Groups A and C).

Trial details

NCT IDNCT02099721

SponsorMedtronic Cardiac Rhythm and Heart Failure

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-07-15

Results submitted2019-08-12