Clinical trials: Pacemakers
Adverse Effect of MRI on an Implanted Pacemaker Lead, Adverse Effect of MRI on an Implanted Pacemaker
Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI…
- Trial name
- NCT01576016
- Testing
- Accent MRI system (lead safety), Accent MRI system (with MRI scan)
- Where
- 70 sites in United States, Australia and 3 more
- Volunteers
- 950 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Sinus Node Dysfunction
Left Bundle Area Versus Selective His Bundle Pacing
This is a voluntary research study to find out which location in the heart a pacemaker wire is the most efficient for a patient's heart and for battery life.
- Conditions
- Bradycardia, Sinus Node Dysfunction, Atrioventricular Block
- Trial name
- LEFTBASH (NCT04093414)
- Testing
- Select Secure pacing lead
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- David Haines, MD
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
Magnetic Resonance Imaging (MRI); Cardiac Pacing
ProMRI Study of the Entovis Pacemaker System (Phase B)
The objective of the ProMRI Study (Phase B) is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions without scan exclusion zone.
- Trial name
- NCT02009696
- Testing
- Patients with a ProMRI Pacemaker System, Magnetic Resonance Imaging (MRI) scan
- Where
- 32 sites in United States
- Volunteers
- 221 people
- Sponsor
- Biotronik, Inc.
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
Bradycardia, Arrhythmia
PREFER (Pacemaker Remote Follow-Up Evaluation and Review)
The purpose of the study is to compare remote pacemaker follow-up to current standard of care follow-up. The study will compare the rate of first diagnosis of clinically actionable events between patients who utilize the…
- Trial name
- NCT00294645
- Testing
- Transtelephonic monitoring (TTM), Medtronic CareLink® Network
- Where
- 45 sites in United States
- Volunteers
- 980 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder
Aveir DR i2i Study
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT05252702
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- 78 sites in United States, Austria and 11 more
- Volunteers
- 464 people
- Sponsor
- Abbott Medical Devices
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
Physical Activity, Pacemaker
Physical Activity and Pacemaker Study
The benefits of regular physical activity are well-established. Furthermore, the investigators have previously shown that in a population of patients with implanted pacemakers, those who exercise more than 2 hours daily have…
- Conditions
- Physical Activity, Pacemaker, Cardiovascular Diseases, Arrythmia
- Trial name
- NCT03052829
- Testing
- Physical activity counseling, Usual care
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Medical College of Wisconsin
Atrioventricular Block, Heart Diseases
Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- BLOCK HF (NCT00267098)
- Testing
- Cardiac Resynchronization Therapy (CRT)
- Where
- 54 sites in United States, Canada
- Volunteers
- 918 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Chronotropic Incompetence
The Effect of Blended Sensor Efficiency on Relieving the Heart's Inability to Increase Its Rate During Exercise
The goal of this trial is to test the effect/benefit of a FDA approved blended pacemaker sensor which responds only by comparing physical activity, heart rate, and breathing rate; compared to the accelerometer pacemaker sensor…
- Trial name
- ABSOLVE CI (NCT01619800)
- Testing
- Blended Sensor Optimization (BSO), Accelerometer Alone (AA)
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Vivek Reddy
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
Bradyarrhythmia
Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086
Pacing leads are key elements of a pacing system as their proper functioning is one of the major factors affecting the long term performance of the whole system.
- Trial name
- NCT01522755
- Testing
- Pacing system implant with the CapsureFix MRI pacing lead model 5086
- Where
- France
- Volunteers
- 409 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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