Clinical trials: Cardiac Pacemaker
Sinus Node Disease
To Pace or Not to Pace in Sinus Node Disease
Optimal pacing strategy for patients with SND is still unknown, although several publications in the past years demonstrated a deleterious effect of ventricular pacing.
- Trial name
- OPTIMIST (NCT02485093)
- Testing
- Septal ventricular pacing, VIP
- Where
- France
- Volunteers
- 215 people
- Sponsor
- Abbott Medical Devices
Tachycardia, Ventricular, Heart Failure, Congestive
OMNI Study--Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices.
The purpose of the OMNI study is to characterize therapy and diagnostic utilization in study participants implanted with study devices and to describe Implantable Cardioverter Defibrillator(ICD)therapy utilization for life…
- Conditions
- Tachycardia, Ventricular, Heart Failure, Congestive, Ventricular Fibrillation, Ventricular Dysfunction
- Trial name
- OMNI (NCT00277524)
- Where
- 113 sites in United States
- Volunteers
- 3,032 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Arrhythmia, Bradycardia
CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse
This study compares the pacemaker's automatic pacing threshold measurements to the manual measurements conducted by a health care provider.
- Trial name
- NCT00275769
- Testing
- Pacemaker
- Where
- 57 sites in United States, Canada
- Volunteers
- 860 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia
Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker
The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.
- Trial name
- DREAM (NCT01537718)
- Testing
- REPLY 200
- Where
- 5 sites in France, Spain
- Volunteers
- 40 people
- Sponsor
- LivaNova
Arrhythmias, Cardiac
SIELLO Pilot Study for Comparison of Steroid Versus Non-Steroid Pacing Leads
This investigation is designed to demonstrate the clinical efficacy and safety of the low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical investigation.
- Trial name
- NCT01000532
- Testing
- SIELLO JT/T, Pacemaker therapy, BPPU JT/T
- Where
- Hungary
- Volunteers
- 88 people
- Sponsor
- Biotronik SE & Co. KG
Ventricular Pacing With Rate Response, Bradycardia
Chronic Evaluation of Novel Pacemaker System
The primary study objective is to evaluate the feasibility, initial clinical safety and potential effectiveness of the Calyan Pacemaker system.
- Trial name
- NCT06056817
- Testing
- Calyan Pacemaker
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Calyan Technologies
Bradycardia, Sinus Node Dysfunction
Physiologic Pacing Registry
The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements…
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT03719040
- Testing
- Physiologic pacing device implant
- Where
- 50 sites in United States, Australia and 14 more
- Volunteers
- 870 people
- Sponsor
- Abbott Medical Devices
Bradycardia
Accent MRI Pacemaker and Tendril MRI Lead New Technology Assessment
The intent of this study is to evaluate the performance of the implanted Accent MRI TM system in a clinical setting and optionally in the MRI environment. This system includes the St.
- Trial name
- NCT01258218
- Testing
- Implantation of an Accent MRI device
- Where
- Austria
- Volunteers
- 78 people
- Sponsor
- Abbott Medical Devices
Device Replacement, Elective Replacement (ERI)
REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
The objective of this study is to prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a…
- Conditions
- Device Replacement, Elective Replacement (ERI), Device Advisory, Device Upgrade
- Trial name
- REPLACE (NCT00395447)
- Testing
- Straight-forward Device Replacement, Device Replacement with Upgrade
- Where
- 71 sites in United States
- Volunteers
- 1,744 people
- Sponsor
- Biotronik, Inc.
Bradycardia
Assessment of Intracardiac Electrograms Transmitted by Home Monitoring for the Remote Follow-up of Pacemaker (PREMS)
The purpose of the PREMS study is to evaluate the capability of the periodic IEGM feature (intracardiac electrogram) to provide more extensive remote information about cardiac rhythm, sensing and capture, and thus to detect…
- Trial name
- PREMS (NCT02174484)
- Where
- 49 sites in France
- Volunteers
- 571 people
- Sponsor
- Biotronik SE & Co. KG
Cardiac Rhythm Disorder, Bradycardia
Patient Preferences for Leadless Pacemakers
Prospective, non-randomized, multi-center study designed to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers
- Conditions
- Cardiac Rhythm Disorder, Bradycardia, Cardiac Pacemaker Artificial
- Trial name
- NCT05327101
- Testing
- Patient Preference Survey
- Where
- 11 sites in United States
- Volunteers
- 117 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Stroke
TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics
The purpose of this study is to look at the heart rate and rhythm information collected daily in Medtronic implantable pulse generators (IPG), implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy…
- Conditions
- Atrial Fibrillation, Stroke, Heart Failure
- Trial name
- NCT00279981
- Testing
- Diagnostic
- Where
- 98 sites in United States, Australia and 1 more
- Volunteers
- 3,100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Pacing, Pacing Therapy
Ventricular Electrical Synchronization by Stimulating Left and Right Bundle Branches Area in Pacing-indicated Patients
This is a prospective, single-site, non-randomized, acute feasibility clinical study. The purpose of this study is to explore the electrocardiogram (ECG) characteristics of simultaneous stimulation of right and left bundle…
- Conditions
- Cardiac Pacing, Pacing Therapy, Pacemaker
- Trial name
- NCT04023890
- Where
- China
- Volunteers
- 22 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Left Ventricular Dysfunction
PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing
This study will be done in patients who require the implantation of a cardiac pacemaker (an electronic device that controls the heartbeat) for complete heart block (a heart rhythm abnormality resulting in a slow heart beat).
- Trial name
- PROTECT-PACE (NCT00461734)
- Testing
- RV lead placement site
- Where
- 18 sites in Australia, New Zealand and 1 more
- Volunteers
- 248 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation, Bradycardia
Study for Atrial Fibrillation Reduction (SAFARI)
Atrial fibrillation (AF), which is the name for rapid beats in the upper chambers of the heart, is the world's most common kind of irregular heart beat.
- Trial name
- NCT00267137
- Testing
- Pacing Algorithms
- Where
- 34 sites in United States
- Volunteers
- 540 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
AV Block, AV Block Complete
Accelerometer Sensing for Micra AV Study
The purpose of the AccelAV Study is to characterize chronic AV synchrony in subjects implanted with MicraTM AV device. This study will be conducted upon market approval of the MicraTM AV Transcatheter Pacing System.
- Conditions
- AV Block, AV Block Complete, 3rd Degree Heart Block, Complete Heart Block
- Trial name
- AccelAV (NCT04245345)
- Testing
- Accelerometer Sensing for Micra AV Study
- Where
- 20 sites in United States, Hong Kong
- Volunteers
- 157 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
Optimize RV Selective Site Pacing Clinical Trial
The purpose of the Optimize RV study is to determine the long-term effect of selective site pacing. Selective site pacing refers to which area of the right ventricle the lead is placed.
- Trial name
- NCT00422669
- Testing
- Medtronic Dual-Chamber Pacemaker, Medtronic SelectSecure 3830 Lead
- Where
- 22 sites in United States, Canada and 4 more
- Volunteers
- 205 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
CareLink® Network Evaluation
The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in clinical practice in the country specific healthcare setting.
- Trial name
- NCT01023022
- Testing
- Medtronic CareLink® Network
- Where
- 10 sites in Poland
- Volunteers
- 176 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Diseases
A Phase I Study to Assess the Electrophysiologic Effects of BMS-394136 on the Atrium and Ventricle in Patients With Dual-Chamber Pacemakers or Defibrillators
Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Subjects with Implanted Dual-Chamber Pacemakers or Defibrillators
- Trial name
- NCT00162448
- Testing
- BMS-394136
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Bristol-Myers Squibb
Cardiac Arrhythmia
SJM MRI Diagnostic Imaging Registry (IDE)
This study is a prospective, non-randomized, multi-center study of subjects implanted with an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices who are clinically…
- Trial name
- NCT02807948
- Testing
- Pacemaker, ICD, or CRT device
- Where
- 58 sites in United States
- Volunteers
- 189 people
- Sponsor
- Abbott Medical Devices