Clinical trials: Cardiac Pacemaker
Congenital Disorder
Pacemaker Therapy in Adults With Congenital Heart Defects
Review the feasibility, safety and outcomes in adults with congenital heart disease who undergo pacemaker implantation for bradycardia, tachycardia or heart failure indications
- Trial name
- NCT00303511
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Emory University
Arrhythmias, Cardiac
Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices
Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.
- Trial name
- NCT01130896
- Where
- United States
- Volunteers
- 1,509 people
- Sponsor
- Johns Hopkins University
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
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.
Heart Failure With a Preserved Ejection Fraction, Heart Failure, Diastolic
Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure
Determine the impact of restoring normal heart rate response during exercise and daily activity in patients with heart failure and a preserved ejection fraction (HFpEF) and chronotropic incompetence (CI).
- Conditions
- Heart Failure With a Preserved Ejection Fraction, Heart Failure, Diastolic, Chronotropic Incompetence
- Trial name
- RAPID-HF (NCT02145351)
- Testing
- Rate adaptive atrial pacing using a dual-chamber pacemaker, Pacemaker system will be implanted but set to Pacing Off.
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Mayo Clinic
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
Heart Diseases, Left Ventricular Dysfunction
InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's
The primary reason the investigators are doing this study are to understand how the right side of the heart functions in heart failure patients with left ventricular assist devices (LVADs, or "mechanical hearts").
- Trial name
- ROBIN (NCT03232736)
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
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
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
Atrioventricular Block, Sick Sinus Syndrome
AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals
This is a randomized, prospective clinical trial to determine the effects of two different pacemaker atrioventricular delay (AV delay) settings on heart function in patients with dual chamber pacemakers implanted for symptomatic…
- Conditions
- Atrioventricular Block, Sick Sinus Syndrome, Symptomatic Bradycardia, Cardiac Arrhythmia
- Trial name
- AV Delay (NCT02154750)
- Testing
- Long, fixed AV delay, Short, optimized AV delay
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- University of California, San Diego
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
Atrial Fibrillation
Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation
The primary objective of this study is to evaluate the effect of ranolazine and of low-dose dronedarone when given alone and in combination at different dose levels on atrial fibrillation burden (AFB) over 12 weeks of treatment.
- Trial name
- HARMONY (NCT01522651)
- Testing
- Ranolazine, Dronedarone
- Where
- 50 sites in United States, Germany and 5 more
- Volunteers
- 134 people
- Sponsor
- Gilead Sciences
Atrial Fibrillation, Tachycardia, Supraventricular
Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
The purpose of this study is to find out if specialized programs in the AT500 and EnRhythm pacemakers will reduce the number of irregular heartbeat in the upper chamber of the heart and reduce symptoms (such as shortness of…
- Conditions
- Atrial Fibrillation, Tachycardia, Supraventricular, Arrhythmia, Bradycardia
- Trial name
- NCT00289289
- Testing
- Intervention Pacing Features
- Where
- 38 sites in United States, Canada
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Pacing, Right Ventricular Pacing
Optimize RV Follow-up Selective Site Pacing Clinical Trial
The purpose of the Optimize RV Follow-Up 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.
- Conditions
- Cardiac Pacing, Right Ventricular Pacing, Left Ventricular Ejection Fraction
- Trial name
- ORVFUP (NCT00949715)
- Testing
- Medtronic or Vitatron Dual-Chamber Pacemaker, Medtronic SelectSecure 3830 Lead
- Where
- 12 sites in United States, Israel and 1 more
- Volunteers
- 67 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradyarrhythmia
Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function
The technological progress allowed the development of more and more sophisticated pacemakers, widening the therapeutic indications but also meeting the physiological needs of the patient.
- Trial name
- NCT01513538
- Testing
- TherapyGuide
- Where
- France
- Volunteers
- 700 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation, Arrythmia
Arrythmia Burden in Cardiac Contractility Modulation (CCM)
The Impulse Dynamics Optimizer Device is a Food and Drug Administration (FDA) approved; commercially available device indicated for patients with heart failure with reduced ejection fraction (HFrEF).
- Trial name
- ABC (NCT05704426)
- Testing
- Impulse Dynamics Optimizer Device
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Hackensack Meridian Health
Cardiovascular Disease
Comparison of Cyanoacrylate Tissue Adhesive and Suture for Closure of Cardiac Device Pockets
The purpose of this study is to determine whether cyanoacrylate tissue adhesive is as effective as polyglactin 910 suture for surgical closure of cardiac device pockets.
- Trial name
- NCT00674128
- Testing
- Cyanoacrylate tissue adhesive (Dermabond), Polyglactin 910 suture (Vicryl)
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- Mayo Clinic
Bradycardia
Accent Cardiac MRI Study
The aim of this study was to assess safety and efficacy of SJM MRI conditional pacing system. The study hypothesized that cardiac MRI scan would not affect performance of SJM MRI conditional pacing system.
- Trial name
- Accent Cardiac (NCT02041702)
- Testing
- Non-Diagnostic Cardiac MRI scan
- Where
- 13 sites in China, Hong Kong and 3 more
- Volunteers
- 283 people
- Sponsor
- Abbott Medical Devices