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
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
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
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
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.
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.
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
Indications for VVI(R) Pacemaker
The LEADLESS Observational Study
The objective of the study is to confirm clinical performance and safety of the Nanostim leadless cardiac pacemaker system within its intended use and according to its instructions for use.
- Trial name
- NCT02051972
- Testing
- Implanted with a Nanostim leadless pacemaker system
- Where
- 32 sites in Czechia, France and 5 more
- Volunteers
- 491 people
- Sponsor
- Abbott Medical Devices
Magnetic Resonance Imaging, Cardiac Pacemaker, Artificial
Advisa MRI Clinical Study
The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR)…
- Trial name
- NCT01110915
- Testing
- Medtronic Advisa MRI Implantable Pulse Generator (IPG), Medtronic CapSureFix MRI™ active fixation MRI lead
- Where
- 37 sites in United States, Australia and 11 more
- Volunteers
- 269 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
Sinus Arrhythmia, Atrial Fibrillation
Electrophysiologically Guided PAcing Site Selection Study
This study is a long-term, prospective, and controlled evaluation of the incidence of persistent atrial fibrillation (AF) in patients with severe intra-right atrial conduction delay paced with preventive algorithms at the…
- Trial name
- EPASS (NCT00239226)
- Testing
- IAS pacing - study group, IAS pacing control group, Pacing RAA study group
- Where
- 8 sites in Italy
- Volunteers
- 102 people
- Sponsor
- Medtronic BRC
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
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
Pacemaker
BRADYCARE: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes
Pacemaker technology is constantly evolving. In the past 10 years, numerous advancements have been made in pacemaker therapy, diagnostics and connectivity.
- Trial name
- BRADYCARE (NCT01062126)
- Volunteers
- 3,389 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Congestive Heart Failure
Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace
The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing…
- Trial name
- AVAIL (NCT00356057)
- Testing
- Protos DR/CLS and Stratos LV CRT pacemakers
- Where
- 10 sites in United States
- Volunteers
- 153 people
- Sponsor
- Biotronik, Inc.
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
Atrial Fibrillation
Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers
Primary objective was to evaluate the effects of dronedarone on Atrial Fibrillation (AF) burden (i.e. percent time in AF) as measured on electrogram (EGM) in subjects with a permanent pacemaker.
- Trial name
- HESTIA (NCT01135017)
- Testing
- Dronedarone
- Where
- 92 sites in United States
- Volunteers
- 112 people
- Sponsor
- Sanofi