Clinical trials: Pacemaker
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
Pacemaker Therapy, Cardiac Resynchronization Therapy
BIO|MASTER.Edora Family Study
This study is designed as post market clinical follow-up study with CE-marked products to evaluate the AV Opt and LV VectorOpt features in the respective Edora family pacemakers under clinical conditions.
- Trial name
- NCT03091322
- Testing
- Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8
- Where
- 11 sites in Austria, Germany and 2 more
- Volunteers
- 120 people
- Sponsor
- Biotronik SE & Co. KG
Cardiac Resynchronization, Biventricular Pacemakers, Artificial
Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication
Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS.
- Conditions
- Cardiac Resynchronization, Biventricular Pacemakers, Artificial, Cardioverter-Defibrillators, Implantable, Device Replacement
- Trial name
- BioCONTINUE (NCT02323503)
- Testing
- CRT-D device replacement
- Where
- 37 sites in Belgium, France and 6 more
- Volunteers
- 289 people
- Sponsor
- Biotronik SE & Co. KG
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
Cardiac Pacemaker Syndrome
Master Study for the Investigation of Safety and Efficacy of the SIELLO Pacemaker Leads
The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.
- Trial name
- NCT00943046
- Testing
- Pacemaker therapy
- Where
- Germany
- Volunteers
- 164 people
- Sponsor
- Biotronik SE & Co. KG
Pacemaker
CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements
The primary objective of this study is to evaluate the efficacy of the automated data collection in the Zephyr device as compared to manual testing results for atrial and ventricular pacing thresholds.
- Trial name
- CONFIRM (NCT00832988)
- Testing
- VentricularAutoCaptureTM & ACapTM Confirm
- Where
- 6 sites in Canada
- Volunteers
- 115 people
- Sponsor
- Abbott Medical Devices
Pacemaker
REmote MOnitoring Transmission Evaluation of IPGs
The purpose of this study is to evaluate the potential clinical and economic benefits of using CareLink remote management for pacemaker follow-up. Study Objectives include: 1.
- Trial name
- REMOTE-IPG (NCT00631709)
- Testing
- CareLink Remote Monitoring
- Where
- 3 sites in Canada
- Volunteers
- 120 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
Patients Implanted With a Pacemaker
Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers
Observational study to assess AV block incidence and their evolution according to paroxysmal atrial arrhythmia.
- Trial name
- NATURE (NCT00531037)
- Where
- 129 sites in United States, Belgium and 9 more
- Volunteers
- 1,440 people
- Sponsor
- LivaNova
Cardiac Pacemaker, Artificial
Clinical Investigation Plan for the AVOPT Data Collection Clinical Study
The purpose of this study is to collect clinical data for the development and evaluation of a new device feature for automatic AV-delay (AVD) optimization.
- Trial name
- NCT03049722
- Testing
- Pacemaker
- Where
- 2 sites in Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Biotronik Canada Inc
Safety of the ProMRI Pacemaker System Under Specific MRI Conditions
ProMRI Study of the Entovis Pacemaker System
The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions.
- Trial name
- NCT01761162
- Testing
- Patients with a ProMRI Pacemaker System, Magnetic Resonance Imaging (MRI) scan
- Where
- 25 sites in United States
- Volunteers
- 229 people
- Sponsor
- Biotronik, Inc.
Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs
ProMRI PROVEN Master Study
This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker…
- Trial name
- NCT01809665
- Testing
- ICD/CRT-P therapy, MRI
- Where
- 23 sites in Australia, Austria and 6 more
- Volunteers
- 174 people
- Sponsor
- Biotronik SE & Co. KG
Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients.
Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication
The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients.
- Trial name
- ANSWER (NCT00562107)
- Testing
- Symphony DR 2550 and REPLY DR cardiac pacemakers
- Where
- 37 sites in United States, France and 4 more
- Volunteers
- 650 people
- Sponsor
- LivaNova
Dual-chamber Pacemaker Placement
Clinical Evaluation of the Sorin Group's REPLY MR-conditional Pacing System
Permanent cardiac pacemakers have represented a contraindication to Magnetic Resonance Imaging (MRI). Strong static, gradient and radiofrequency fields used for MRI are thought to be detrimental to pacemaker function and possibly…
- Trial name
- NCT01341522
- Testing
- MRI exam, control
- Sponsor
- LivaNova
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 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
Pacemaker Indication
Ventricular Pace Suppression Study
Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.
- Trial name
- VpS (NCT01053832)
- Testing
- VpS algorithm in EVIA and ENTOVIS pacemakers
- Where
- 2 sites in Germany
- Volunteers
- 84 people
- Sponsor
- Biotronik SE & Co. KG
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
Any Patient Who Fulfills the Inclusion Criteria to be Implanted With a Dual Chamber Pacemaker Maybe Included in the Study as Per ACC/AHA Guidelines
Comparison of AAIsafeR and DDD Modes in Non-selected Patients
1 Purpose In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated bradycardia, single chamber atrial pacemakers…
- Trial name
- CAN-SAVE R (NCT01219621)
- Testing
- Symphony Dual Chamber Rate Responsive Device
- Where
- 10 sites in Canada
- Volunteers
- 450 people
- Sponsor
- Sorin Group Canada
Pacemaker, Artificial, Bradycardia
Evaluate the Benefits of Pacemaker Follow-Up With Home-Monitoring
The study investigates whether home monitoring follow-up of Pace-Maker patients is as efficient as conventional method in terms of Significant Serious Adverse Event (SSAE).
- Trial name
- COMPAS (NCT00989326)
- Testing
- Home Monitoring
- Where
- France
- Volunteers
- 543 people, healthy volunteers welcome
- Sponsor
- Biotronik France