N/A N=10 Pacemaker Therapy in Adults With Congenital Heart Defects
Congenital Disorder
Primary: Feasibility of Pacemaker Implant With Total Thoracoscopic Approach to Epicardial Pacing Lead — 100 percentage of particiapants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=1,745 Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
Bradyarrhythmia
Primary: Two-year All-cause Mortality — 11 percentage of participants
N/A N=1,833 Biopace Study: Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization
Atrioventricular Block · Ventricular Dysfunction
Primary: Total Mortality — 307; 305 Participants — p=0.3492
N/A N=240 PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing
Left Ventricular Dysfunction
Primary: Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort). — -2.29; -3.43 percentage — p=0.4347
Phase 4 N=605 PreFER Managed Ventricular Pacing (MVP) For Elective Replacement
Cardiovascular Diseases
Primary: Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant — 43; 40 number of participants — p=0.72
N/A N=2,101 Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II
Standard Bradycardia Pacing Indication
Primary: Percentage of Participants With Complications in the General Pacemaker Population — 3.33 percentage of subjects
N/A N=22 InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's
Heart Diseases · Left Ventricular Dysfunction
Primary: Peak Vo2 — 33; 12.5 ml/kg/min
N/A N=32 Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure
Heart Failure With a Preserved Ejection Fraction · Heart Failure, Diastolic · Chronotropic Incompetence
Primary: Change in Oxygen Consumption (VO2) at Ventilatory Anaerobic Threshold (VAT) — 10.4; 10.7 ml/kg/min
N/A N=3,389 BRADYCARE: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes
Pacemaker
Primary: Complication Rate at 1-year Post-implant — 1.12 percentage of enrolled subjects
N/A N=101 Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
Bifascicular Block · Syncope
Primary: Combined Endpoint Defined as First Occurrence Among the Following Events 1)Syncope Episode of Any Origin; 2)Presyncopal Episode With Documented Cardioinhibitory Origin…
N/A N=23 AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals
Atrioventricular Block · Sick Sinus Syndrome · Symptomatic Bradycardia
Primary: Comparison of Change in Echocardiographic Parameters LV Dimension at End-diastole, LV Dimension at End-systole, and Tricuspid Annular Plane Systolic Excursion (cm) From…
Phase 4 N=67 Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study
Permanent Atrial Fibrillation
Primary: Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE) — 32; 32; 15; 15 participants — p=<0.0001
N/A N=918 Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)
Atrioventricular Block · Heart Diseases
Primary: Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI) — 160; 191; 93; 136 participants…
N/A N=190 Attain Model 4196 Left Ventricular (LV) Lead
Heart Failure
Primary: Safety (Subjects Without a Model 4196 Lead Related Complication) — 168 participants
Phase 4 N=1,491 Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
Bradycardia
Primary: Performance of Activities of Daily Living Tests (6-minute Walk and Sweep) — 19.28; 18.09; 18.05 repetitions — p=0.004
N/A N=22 Endothelial Function and Cardiac Output in RV Pacing
Bradycardia
Primary: Endothelial Function Assessed by Flow Mediated Vasodilatation — 1.96; 1.73 EndoPAT index (EnFI)
Phase 4 N=102 Electrophysiologically Guided PAcing Site Selection Study
Sinus Arrhythmia · Atrial Fibrillation
Primary: Number of Patients With Persistent Atrial Fibrillation (AF) After a Mean Follow-up of 15±7 Months: Comparison Between IAS and RAA Pacing in the Study Group — 2; 2; 9; 2…
N/A N=98 ENHANCE-Efficacy of the Presence of Right Ventricular Apical Pacing Induced Ventricular Dyssynchrony as a Guiding Parameter for Biventricular Pacing in Patients With Bradycardia and Normal Ejection Fraction
Bradycardia
Primary: LVEF — 64.22; 63.14; 59.96 % LVEF — p=0.1734
N/A N=40 The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients.
Chronic Heart Failure · Atrial Fibrillation · Arrhythmia, Sinus
Primary: Maximal Oxygen Consumption (Peak VO2) — 16; 17; 15.3; 14.2 ml/kg/min
Phase 2 N=126 Post-Myocardial Infarction Remodeling Prevention Therapy
Acute Myocardial Infarction · Pacing Therapy · Cardiac Remodeling
Primary: Change in Left Ventricular End Diastolic Volume (LVEDV) — 16.4; 15.8 mL
N/A N=64 Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P)
Post Market Surveillance Study Following Clinical Routine
Primary: Percentage of Participants Without CRT-P Device Related Complications — 100 % of participants — p=<0.001
N/A N=1,999 InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry
Heart Failure · Cardiomyopathy
Primary: Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant. — 450; 213 participants
N/A N=70 IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
Sinus Bradycardia · Sinus Node Disease · Atrio-ventricular Block
Primary: Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months. — 61.9 percentage of patients
N/A N=21 Physical Activity and Pacemaker Study
Physical Activity · Pacemaker · Cardiovascular Diseases
Primary: Physical Activity Level as Measured by Embedded Accelerometer — 1.97; 1.77 active hours/day
Phase 4 N=100 The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock
Ventricular Tachycardia · Ventricular Fibrillation · Atrial Fibrillation
Primary: Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD) — 1; 1 Participants — p=1.0
N/A N=466 Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication
Bradycardia
Primary: Freedom From RA and RV Lead-related Complications — 97.19; 99.14 percentage of participants
N/A N=725 Micra Transcatheter Pacing Study
Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines
Primary: Major Complications — 96.0 Kaplan-Meier survival probability (%) — p=<0.0001
N/A N=1,509 Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices
Arrhythmias, Cardiac
Primary: Device Malfunction — 24; 52 Participants
N/A N=16 AF Septal Pacing (Clinical Investigation Plan)
Paroxysmal Atrial Fibrillation · Persistent Atrial Fibrillation
Primary: Number of Electrodes in a Stable Position — 38 Electrode pairs
N/A N=400 Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
Atrial Fibrillation · Tachycardia, Supraventricular · Arrhythmia
Primary: Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month — 2.0; 1.8 Episodes per subject per month — p=0.629