30 closest matches · ranked by relevance
Heart Failure
Primary: Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response — 1061; 900 Participants
Heart Failure
Primary: Percentage of Patients With Improved Heart Failure Outcomes Clinical Composite Score — 234; 114 Participants — p=0.0002
Congenital Heart Defects
Primary: Cardiac Index — 3.39; 3.42; 3.23 L/min/m2
Heart Failure
Primary: Percentage of Patients Worsened for Clinical Composite Response — 21.5; 16 Percentage of participants worsened — p=0.10
Heart Failure
Primary: Change in Left Ventricle End-Systolic Volume Index (LVESVI) — -11.6; -4.1 mL/m^2 — p=0.0001
Heart Failure
Primary: CRT Response — 116; 105 Participants — p=0.17
Heart Failure
Primary: Responder Rate — 67; 60 percentage of participants
Atrial Fibrillation
Primary: Percentage of Effective CRT Pacing During AF (Non-inferiority Test) — 80.8; 87.8 percentage of effective CRT pacing — p=<0.0001
Heart Failure
Primary: Number of Participants Free of Adverse Effects at 6 Months Post Procedure — 15 Participants
Heart Failure
Primary: Number of CRT Responders — 53 Participants — p=0.0435
Cardiac Resynchronization Therapy · Chronic Heart Failure
Primary: Changes in a Composite Measure of Clinical Status - New York Heart Association Functional Class — -1.52; -1.0 scores on a scale
Heart Failure
Primary: Number of Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet®…
Tachycardia · Congestive Heart Failure
Primary: Mortality From Any Cause or First Heart Failure (HF) Event — 901; 543; 188; 188 Participants — p=< 0.001
Heart Failure
Primary: CRT Responder Rate — 16; 20; 17; 6 participants
Heart Failure · Cardiomyopathy
Primary: Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant. — 450; 213 participants
Cardiomyopathy · Heart Failure · Left Bundle Branch Block
Primary: Change in Ventricular Electrical Uncoupling (VEU), Calculated as the Difference in Difference Between the Mean Left Ventricular (LV) and Right Ventricular (RV)…
Heart Failure
Primary: Enrollment — 22; 20; 18; 42 Participants
Heart Failure
Primary: AV Interval Determination Using Impedance — 14 participants
Heart Failure
Primary: Percentage Change in Positive Left Ventricular dP/dt Max (mmHG/Sec) — 10.59; 12.20; 11.51; 15.64 % change LV dP/dt max
Heart Failure
Primary: Freedom From Left Ventricular Lead-Related Complications Through 3 Months — 96 percentage probability
Heart Failure
Primary: Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score — 11; 7; 10; 16 participants
Heart Failure
Primary: Change in Left Ventricular End Systolic Volume (LVESV) From Baseline to 6 Months Post-implant. — -11.7; -14.7 Percent Change
Dilated Cardiomyopathy
Primary: Aortic Velocity Time Integral (VTI) — 22.4; 21.7; 19.4; 18.1 cm
Heart Failure
Primary: Safety (Subjects Without a Model 4196 Lead Related Complication) — 168 participants
Sudden Cardiac Death
Primary: Defibrillation Threshold Difference Obtained in Volts (V) Between Implant and 6 Months — 5.6 Volts
Congestive Heart Failure
Primary: Change in Left Ventricular Ejection Fraction (LVEF) — 26.3; 30.5; 31.9; 34.0 ejection fraction percentage — p=<0.001
Systolic Heart Failure · Atrial Fibrillation (Permanent)
Primary: Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV) — 5; 6 Participants — p=1.00
Cardiomyopathy
Primary: Change in Left Ventricular Ejection Fraction — 10.6 percentage of LVEF
Bradycardia · Heart Failure
Primary: • ECG Belt Analysis of Standard Deviation of Activation Times (SDAT) of LBBP Compared to Native Conduction — 38.6; 20.5 ms
Heart Failure
Primary: Number of Vectors With Phrenic Nerve Stimulation (PNS) — 181; 189 Number of Pacing vectors with PNS