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=30 Electronic Device Implantation Through Remote Guidance
Telemedicine · Heart Failure · Defibrillators
Primary: Percentage of Participants With Interventional Procedures Successfully Completed — 10; 20 Participants
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=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=1,744 REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
Device Replacement · Elective Replacement (ERI) · Device Advisory
Primary: Percentage of Subjects Experiencing a Complication During Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With…
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=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=190 Attain Model 4196 Left Ventricular (LV) Lead
Heart Failure
Primary: Safety (Subjects Without a Model 4196 Lead Related Complication) — 168 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=194 Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation
Heart Failure, Congestive · Ventricular Dysfunction · Cardiomyopathies
Primary: Survival — 112; 6; 18; 19 participants
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=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…
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=128 Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds
Heart Failure · Ventricular Arrythmias
Primary: Percentage of Participants Free of System-related Complications at 3-months Post Implant — 93.6 Percentage of Participants
N/A N=117 Patient Preferences for Leadless Pacemakers
Cardiac Rhythm Disorder · Bradycardia · Cardiac Pacemaker Artificial
Primary: Mean Rankings for Pacemaker Device Features — 2.3; 2.6; 2.2; 4.7 score on a scale
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
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=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
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=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=24 Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors
TTR Cardiac Amyloidosis
Primary: Sudden Death — 0 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=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=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=52 BIO|CONCEPT.Amvia Study
Bradycardia · Heart Failure
Primary: Serious Adverse Device Effect (SADE)-Free Rate After 12 Months — 52 Participants
N/A N=50 RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators
Cardiomyopathy · Cardiac Arrhythmia · Heart Failure
Primary: Pacing Mode Changes Between Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure — 29; 29; 8; 8 participants — p=1.0
N/A N=47 Synchronized Cardiac Assist for Cardiogenic Shock
Shock, Cardiogenic · High Risk Percutaneous Coronary Interventions
Primary: Number of Participants With Device and Procedure Related Serious Adverse Events — 11; 5 Participants
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=55 Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
ACC/AHA/NASPE Class 1, IIa or IIb Indications
Primary: Conversion of Induced Ventricular Fibrillation — 52 Participants
N/A N=21 C-Pulse IDE Feasibility Study- A Heart Assist System
Heart Failure
Primary: Number of Surviving Participants That Completed the Study — 3 Participants