Improve Sudden Cardiac Arrest Study

Medtronic

Status: Completed

Conditions: Ventricular Arrythmia; Sudden Cardiac Arrest

Treatments: Device: ICD or CRT-D Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02099721

Improve SCA

Details and patient eligibility

About

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.

Full description

Devices allowed in the study include any Medtronic single, dual, or triple chamber defibrillator that has received appropriate license or regulatory approval and is commercially available by Medtronic in the geography in which the implant will take place. Any market-released, commercially available lead(s) can be used in the study.

Enrollment: 4,222 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,222 participants in 6 patient groups

Group A: Secondary prevention patients- device implant

Active Comparator group

Description:

Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects receive an ICD/CRT-D implant.

Treatment:

Device: ICD or CRT-D Device

Group B: Secondary prevention patients - no device implant

No Intervention group

Description:

Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects choose not to receive an ICD/CRT-D implant.

Group C: 1.5 Prevention patients - device implant

Active Comparator group

Description:

Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects receive an ICD/CRT-D implant.

Treatment:

Device: ICD or CRT-D Device

Group D: 1.5 prevention patients - no device implant

No Intervention group

Description:

Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects choose not to receive an ICD/CRT-D implant.

Group E: Primary, non-1.5 patients - device implant

Other group

Description:

Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group. These subjects receive an ICD/CRT-D implant.

Treatment:

Device: ICD or CRT-D Device

Group F: Primary, non-1.5 patients - no device

No Intervention group

Description:

Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group. These subjects choose not to receive an ICD/CRT-D implant.