Clinical Trial Search

Primary: Mortality From Any Cause or First Heart Failure (HF) Event — 901; 543; 188; 188 Participants — p=< 0.001

Primary: Time to the First Occurrence of a Ventricular Arrhythmia — 32.5; 18.3 Estimated 24-Month VT-VF Pct of Patients

Primary: Change in Left Ventricular Ejection Fraction — 10.6 percentage of LVEF

Primary: Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation — 43; 44 participants

Primary: Safety (Subjects Without a Model 4196 Lead Related Complication) — 168 participants

Primary: Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia. — 64.7; 68.2 Percent of VT…

Primary: Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant. — 450; 213 participants

Primary: Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV) — 5; 6 Participants — p=1.00

Primary: Percentage of Participants Free of System-related Complications at 3-months Post Implant — 93.6 Percentage of Participants

Primary: Number of Vectors With Phrenic Nerve Stimulation (PNS) — 181; 189 Number of Pacing vectors with PNS

Primary: Defibrillation Threshold Difference Obtained in Volts (V) Between Implant and 6 Months — 5.6 Volts

Primary: Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD) — 1; 1 Participants — p=1.0

Primary: Conversion of Induced Ventricular Fibrillation — 52 Participants

Primary: Percentage of Participants With Interventional Procedures Successfully Completed — 10; 20 Participants

Primary: Referral for Implantable Cardioverter Defibrillator — 11; 1 participants

Primary: Percentage of Patients Worsened for Clinical Composite Response — 21.5; 16 Percentage of participants worsened — p=0.10

Primary: Inappropriate ICD Therapy — 105; 21; 26 participants — p=<0.001

Primary: Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response — 1061; 900 Participants

Primary: Remote Follow-up as an Alternative to Onsite Visit — 203 Participants

Primary: Percentage of Participants Without CRT-P Device Related Complications — 100 % of participants — p=<0.001

Primary: Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients — 14.4 milli volt (mV)

Primary: Percentage of Patients With Improved Heart Failure Outcomes Clinical Composite Score — 234; 114 Participants — p=0.0002

Primary: All-Cause Mortality — 11; 12 participants — p=0.370

Primary: Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. — 100 percentage of patients — p=<0.03

Primary: Aortic Velocity Time Integral (VTI) — 22.4; 21.7; 19.4; 18.1 cm

Primary: Freedom From Left Ventricular Lead-Related Complications Through 3 Months — 96 percentage probability

Primary: Major CIED Infection — 0.6; 1.0; 0.7 percentage of Participants — p=0.0023

Primary: Number of Participants With Freedom From Magnetic Resonance Imaging (MRI) Scan Related Complications — 14; 14; 15; 12 Participants

Primary: Rate of Defibrillator Electrical Integrity Dysfunction During Generator Replacement. — 1 Participants

Primary: Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up — 122 Participants — p=0.05