Clinical trials: Pacemaker
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
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
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
Persistent Atrial Fibrillation, Cardiac Arrhythmia
Investigation of Therapeutic Ablation Versus Cardioversion for AF
The main aim of the research is to investigate whether patients undergoing pulmonary vein isolation with cryoablation for atrial fibrillation (AF) will have lower rates of AF recurrence than those treated by DC cardioversion…
- Trial name
- ORBITA-AF (NCT03907982)
- Testing
- DC Cardioversion, Pulmonary vein isolation, Implantable loop recorder
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Barts & The London NHS Trust
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
MRI Scans, Magnetic Resonance Imaging
Registry of Patients for MRI With Non-MRI Conditional Pacemakers and ICD Non-MRI Conditional Pacemakers and ICD
The purpose of the registry is to accumulate pre-and post-scan device interrogation data for the purpose of determining the risk of MRI for patients with implantable devices.
- Conditions
- MRI Scans, Magnetic Resonance Imaging, Pacemaker, Implantable Cardioverter Defibrillator
- Trial name
- NCT02318550
- Testing
- MRI Scan
- Where
- United States
- Volunteers
- 262 people
- Sponsor
- Lancaster General Hospital
Analgesia After Pacemaker, AICDS Implantation Pediatrics
Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of Automatic Implantable Cardioverter Defibrillators (AICDs) and Pacemakers in Pediatric Patients
The purpose of this study is to determine the efficacy and safety of truncal blocks for pacemaker and Automatic Implantable Cardioverter Defibrillator implantation in children and to prospectively evaluate whether there is a…
- Trial name
- NCT04184349
- Testing
- LA group, B Group
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- The University of Texas Health Science Center, Houston
Cardiac Pacemaker, Artificial
Imaging Study of Lead Implant for His Bundle Pacing
The purpose of this research study is to assess the implant success proportion of the Medtronic SelectSecure MRI SureScan Model 3830 pacing lead at the bundle of His for His bundle pacing.
- Trial name
- (IMAGE-HBP) (NCT03294317)
- Testing
- His bundle pacing
- Where
- 3 sites in United States
- Volunteers
- 70 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
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
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
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