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=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)
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
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=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=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…
Phase 4 N=1,742 PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy
Heart Failure
Primary: Clinical Composite Score — 230; 235; 229; 84 participants — p=0.55
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=34 Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery
Congenital Heart Defects
Primary: Cardiac Index — 3.39; 3.42; 3.23 L/min/m2
N/A N=870 Physiologic Pacing Registry
Bradycardia · Sinus Node Dysfunction · Heart Block
Primary: Physiologic Pacing Implant Success Rate — 768 Participants
N/A N=15 An Assessment of Dual Site Left Ventricular Endocardial Pacing
Atrial Fibrillation · Ventricular Tachycardia · Heart Failure
Primary: Acute Haemodynamic Response to Dual Left Ventricular Pacing — 3.7 % difference — p=<0.05
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=20 ECG Belt to Assess Electrical Synchronization
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
N/A N=20 A Pilot Study of Interventricular Septal Puncture for Cardiac Resynchronization Therapy to Treat Heart Failure
Heart Failure
Primary: Number of Participants Free of Adverse Effects at 6 Months Post Procedure — 15 Participants
N/A N=12 Subcostal Temporary Extracardiac Pacing Study
Conduction Defect
Primary: Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect — 2 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=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
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=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=749 Quadripolar CRT-D On Currently Approved Lead SystemS
Heart Failure
Primary: Number of Vectors With Phrenic Nerve Stimulation (PNS) — 181; 189 Number of Pacing vectors with PNS
N/A N=13 Effect of Chronic Changes in Heart Rate on Congestive Heart Failure
Heart Failure, Congestive
Primary: Ejection Fraction — 33; 30; 25 % of blood ejected with each beat
N/A N=187 Predictors of Response to Biventricular Pacing in Heart Failure
Heart Failure, Wide QRS Complex
Primary: Minnesota For Living With Heart Failure Questionnaire — 31; 24 units on a scale
N/A N=305 Electronic Repositioning With Acuity and Easytrak Leads
Heart Failure
Primary: Proportion of Patients Without the Occurrence of Cardiac Resynchronization Therapy (CRT)-Induced Phrenic Nerve Stimulation (PNS) Between Implant and First Regular…
N/A N=14 REmodeling the Left Ventricle With Atrial Modulated Pacing
Heart Failure
Primary: Number of Participants Who Remained on Study — 9; 4 participants
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=31 Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for Cardiac Resynchronization Therapy (CRT)
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
N/A N=41 His Bundle Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy
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
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=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