Clinical trials: Pacemaker
Pacemaker Indication
Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker
The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and…
- Trial name
- NCT00916344
- Testing
- EVIA Pacemaker
- Where
- France
- Volunteers
- 175 people
- Sponsor
- Biotronik SE & Co. KG
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
Heart Diseases
APPROPRIATE - Rate Adaptive Pacing Sensor
The APPROPRIATE study will compare differences in functional capacity (peak VO2) between chronotropically incompetent patients randomized to receive rate responsive pacing driven by either the minute ventilation…
- Trial name
- APPROPRIATE (NCT00757666)
- Testing
- Rate adaptive pacemaker
- Where
- 2 sites in United States
- Volunteers
- 566 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Heart Failure
AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study
The purpose of this study is to determine whether early atrioventricular node (AVN) ablation with pacing device therapy will reduce death and hospitalization when compared to the conventional drug therapy in elderly patients with…
- Trial name
- PACIFIC (NCT00589303)
- Testing
- FDA approved rate and rhythm control drugs, AV Node ablation and device implant
- Where
- 6 sites in United States, Canada
- Volunteers
- 27 people
- Sponsor
- Mayo Clinic
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
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
Electromagnetic Interference
Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices
Patients with implanted pacemaker (PM) or cardioverter-defibrillator (ICD) systems are restrained in daily life by possible electromagnetic interference (EMI).
- Trial name
- NCT01369706
- Testing
- Hand-held metal detector
- Where
- 2 sites in Germany, Greece
- Volunteers
- 388 people
- Sponsor
- Deutsches Herzzentrum Muenchen
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
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
Cardiac Pacemaker, Artificial, Implantable Cardioverter-Defibrillator
Actions Elicited by In-hospital Follow-up of Cardiac Devices
This study will enroll all patients who will attend an in-hospital follow-up of cardiac device since February 22nd 2010 to June 21st 2010.
- Trial name
- ATHENS (NCT01073449)
- Testing
- In-hospital follow-up of cardiac device
- Where
- 8 sites in Italy
- Volunteers
- 3,362 people
- Sponsor
- Cliniche Humanitas Gavazzeni
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
Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines
Micra Transcatheter Pacing Study
The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.
- Trial name
- NCT02004873
- Testing
- Micra Pacemaker Implant
- Where
- 56 sites in United States, Australia and 17 more
- Volunteers
- 744 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Bradycardia
Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
This is a randomized, prospective, single-blinded, multi-center study involving approximately 1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness of Closed Loop Stimulation (CLS) rate…
- Trial name
- CLEAR (NCT00355797)
- Testing
- Closed Loop Stimulation (CLS), Standard Rate Adaptive (R) Technology, Non-rate adaptive (DDD) pacing
- Where
- 99 sites in United States
- Volunteers
- 1,491 people
- Sponsor
- Biotronik, Inc.
Bradycardia
A Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing
The COMPARE-Adapta study is a randomized, multi-center, prospective study conducted in China. The purpose of the study is to compare the ability of Search AV™+ and Managed Ventricular Pacing® (MVP®) to reduce ventricular pacing…
- Trial name
- COMPARE (NCT01039467)
- Testing
- Medtronic Adapta Dual Chamber Pacemaker
- Where
- 30 sites in China
- Volunteers
- 385 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiomyopathy, Cardiac Arrhythmia
RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators
If a surgical sponge is mistakenly left inside a patient's body after a surgical procedure, it can cause a serious infection. To prevent this from happening, a new device has been developed that uses radiofrequency (RF) signals…
- Conditions
- Cardiomyopathy, Cardiac Arrhythmia, Heart Failure, Chronic Thromboembolic Pulmonary Hypertension
- Trial name
- RF (NCT02111980)
- Testing
- RF Assure Scanning
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Diego
Bradycardia, Heart Failure
BIO|CONCEPT.Amvia Study
The goal of this exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P)…
- Trial name
- NCT05610176
- Testing
- Amvia Sky pacemaker or CRT-P device
- Where
- 7 sites in Australia, New Zealand
- Volunteers
- 52 people
- Sponsor
- Biotronik Australia Pty Ltd.
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
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, Atrial Tachyarrhythmia
Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)
The purpose of this study is to evaluate the effects that electromagnetic field exposure from using a tablet and smart phone have on a leadless pacemaker (MICRA device).
- Trial name
- MICRA (NCT02758210)
- Testing
- Use of a Tablet, Use of a Smart Phone
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Emory University