Phase 3 N=89 Implantable Cardioverter-Defibrillator Use in the VA System
Cardiomyopathies
Primary: Referral for Implantable Cardioverter Defibrillator — 11; 1 participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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
Phase 3 N=193 Psychological Support for Patients With an Implantable Cardioverter Defibrillator
Anxiety · Depression
Primary: Hospital Anxiety and Depression Scale - Depression Scale at Baseline — 4.70; 7.47; 5.35; 4.12 units on a scale
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=6 Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Ventricular Tachyarrhythmias
Primary: Number of Participants With a Successful Induced Ventricular Fibrillation Conversion — 6 Participants
N/A N=143 Defibrillation Testing During Implantable Cardioverter Defibrillator (ICD) Replacement
Implantable Cardioverter-Defibrillators
Primary: Rate of Defibrillator Electrical Integrity Dysfunction During Generator Replacement. — 1 Participants
N/A N=14 ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
Tachycardia · Ventricular Arrythmia
Primary: Safety Outcome - Freedom From Major Complications Related to the EV ICD System and/or Procedure at 2 Weeks Post-implant — 13 Participants
N/A N=26 Extravascular ICD Pilot Study
Tachycardia · Ventricular Arrythmia
Primary: Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation — 18 Participants
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=215 Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation Lead
Ventricular Tachycardia · Ventricular Fibrillation
Primary: Implant Success Rate at Septal Site — 97; 99 Participants
N/A N=48 Acute Subcutaneous Defibrillation
Ventricular Arrhythmias
Primary: Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System. — 85.7 percentage of success
N/A N=321 S-ICD® System IDE Clinical Study
Tachycardia, Ventricular
Primary: Percentage of Participants Free of Type I Complications at 180 Days. — 99.0 percentage of participants
N/A N=388 Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices
Electromagnetic Interference
Primary: Electromagnetic Interference — 0 participants
N/A N=2,500 Shockless Implant Evaluation
Ventricular Fibrillation · Ventricular Tachycardia
Primary: First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death — 90; 104…
N/A N=32 The Effect of an Azygos Vein Coil on Defibrillation Threshold
Heart Failure
Primary: Difference in the DFT With an Azygos Vein Coil Versus the Standard SVC Coil. — 10.4; 12.2 Joules — p=0.103
N/A N=790 A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
Heart Failure, Systolic · Heart Failure
Primary: Knowledge About Defibrillation at Baseline — 53.4; 55.4 score on a scale
N/A N=100 Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System.
Ventricular Fibrillation · Ventricular Tachycardia
Primary: Number of Patients With Skin Symptoms — 0 Participants
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
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=3,889 Improve Sudden Cardiac Arrest Study
Sudden Cardiac Arrest · Ventricular Arrythmia
Primary: Time to the First Occurrence of a Ventricular Arrhythmia — 32.5; 18.3 Estimated 24-Month VT-VF Pct of Patients
N/A N=994 Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) Registry
Tachycardia, Ventricular
Primary: Perioperative S-ICD Complication Free Rate — 983 Participants
N/A N=81 SecuraTM ICD Clinical Evaluation Study
Tachyarrhythmias
Primary: Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. — 0 percentage of patients
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=2,120 SAFEty of Two Strategies of ICD Management at Implantation
Ventricular Fibrillation · Ventricular Flutter · Sudden Cardiac Death
Primary: Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up — 18; 16 Participants
N/A N=354 Full Automaticity and Remote Follow-up
Tachyarrhythmia
Primary: Remote Follow-up as an Alternative to Onsite Visit — 203 Participants
N/A N=183 A Study of Physical Activity paTTerns and Major Health Events in Older People With Implantable Cardiac Devices
Physical Activity · Aging · Cardiac Disease
Primary: Non-elective Hospital Admissions — 2; 3; 31; 104 Participants
N/A N=1,701 SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
Tachyarrhythmias · Sudden Cardiac Death · Heart Failure
Primary: Right Ventricle (RV) Bipolar Capture Thresholds — 0.92 Volts
N/A N=59 Hospital Wearable Defibrillator Inpatient Study
In-Hospital Cardiac Arrest
Primary: Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise. — 0.53; 2.54 percentage of time worn
N/A N=239 ENABLE MRI (Magnetic Resonance Imaging)
Magnetic Resonance Imaging
Primary: Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications — 100 percentage of participants
N/A N=100 Comparison of VF Induction Techniques During Medtronic ICD Implant (VF) (ICD)
Cardiomyopathy
Primary: Sustained Ventricular Fibrillation — 38; 35 participants