Clinical trials: Bradyarrhythmia
Atrial Fibrillation, Bradycardia
Avoid FFS - Use of the Atrial Pacemaker Lead 1699 With Very Short Tip Ring Spacing to Avoid Far Field Sensing
The purpose of this study is to evaluate the possibility to program the shortest possible Post Ventricular Atrial Blanking Period (PVAB) and high sensitivity without getting inappropriate Mode Switch due to Far Field R-Wave…
- Trial name
- Avoid FFS (NCT00512915)
- Testing
- pacemaker implantation
- Where
- 10 sites in Germany
- Volunteers
- 204 people
- Sponsor
- Abbott Medical Devices
Ventricular Pacing With Rate Response, Bradycardia
Chronic Evaluation of Novel Pacemaker System
The primary study objective is to evaluate the feasibility, initial clinical safety and potential effectiveness of the Calyan Pacemaker system.
- Trial name
- NCT06056817
- Testing
- Calyan Pacemaker
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Calyan Technologies
Shortness of Breath, Chest Pain
Checklists Resuscitation Emergency Department
The study will systematically evaluate how an emergency manual-a collection of checklists and fact sheets-affects the performance of resuscitation teams during the management of priority one patients in an emergency department.
- Conditions
- Shortness of Breath, Chest Pain, Abdominal Pain, Altered Mental Status
- Trial name
- NCT05649891
- Testing
- Emergency Manual
- Volunteers
- 2,000 people
- Sponsor
- Region Skane
Bradycardia
Micra Transcatheter Pacing System Post-Approval Registry
Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial…
- Trial name
- NCT02536118
- Testing
- Micra Transcatheter Pacing System
- Where
- 156 sites in United States, Belgium and 22 more
- Volunteers
- 3,100 people
- Sponsor
- Medtronic
Heart Failure
Choosing the Right Pacing Mode in Heart Failure - The CHOICE Trial
The aim of the study is to see if biventricular pacemakers offer any advantage over conventional pacemakers in patients with heart failure who require pacemakers.
- Trial name
- CHOICE (NCT00875732)
- Testing
- Bi Ventricular Pacing, Right Ventricular Pacing
- Where
- United Kingdom
- Volunteers
- 22 people
- Sponsor
- University of Dundee
Apnea of Prematurity, Preterm Birth
Hemodynamic Responses to Cardio-respiratory Events in Preterm Infants
Intermittent episodes of hypoxemia and/or bradycardia, also defined as cardio-respiratory events (CRE) are very frequent in preterm infants and may result in transient hypoxia and hypoperfusion of target organs, with possible…
- Conditions
- Apnea of Prematurity, Preterm Birth, Patent Ductus Arteriosus, Hypoxia, Brain
- Trial name
- NCT04184245
- Where
- Italy
- Volunteers
- 42 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 During Pulling of Eyeball
Autonomic Nervous System Activity and Oculocardiac Reflex.
Pulling the eyeball during ophthalmic surgery provokes decrease in heart rate. This phenomenon is called oculocardiac reflex. In some patients asystole may occur.
- Trial name
- NCT01714362
- Where
- Poland
- Volunteers
- 52 people
- Sponsor
- Medical University of Gdansk
Gastroesophageal Reflux, Apnea
Study of Erythromycin in GER-Associated Apnea of the Newborn
To evaluate the relationship of reflux and apnea and to determine whether the administration of erythromycin improves the incidence of GER and GER-associated apnea, bradycardic and/or desaturation events in a prospective…
- Conditions
- Gastroesophageal Reflux, Apnea, Bradycardia
- Trial name
- SEGAN (NCT01825473)
- Testing
- Erythromycin, Multi-channel intra-luminal impedance (MII) pH monitoring
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Bifascicular Block, Syncope
Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
Study Objective The purpose of this study is to evaluate the efficacy of bradycardia pacing with respect to patient symptoms in patients with bifascicular block and syncope of unexplained origin.
- Trial name
- PRESS (NCT01463358)
- Testing
- DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)
- Where
- 12 sites in Italy
- Volunteers
- 101 people
- Sponsor
- Boston Scientific Corporation
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
Bradycardia
Assessment of Intracardiac Electrograms Transmitted by Home Monitoring for the Remote Follow-up of Pacemaker (PREMS)
The purpose of the PREMS study is to evaluate the capability of the periodic IEGM feature (intracardiac electrogram) to provide more extensive remote information about cardiac rhythm, sensing and capture, and thus to detect…
- Trial name
- PREMS (NCT02174484)
- Where
- 49 sites in France
- Volunteers
- 571 people
- Sponsor
- Biotronik SE & Co. KG
Arrythmia, Bradycardia
Safety and Effectiveness of the External Fastening System for Temporary Active Fixation Pacemakers (TEMPACE)
Temporary cardiac pacing with active-fixation leads (TPAFL) using a reusable permanent pacemaker generator has been shown to be safer than lead systems without fixation.
- Trial name
- TEMPACE (NCT05351658)
- Testing
- KronoSafe® System
- Where
- 2 sites in Spain
- Volunteers
- 30 people
- Sponsor
- ICU Medical Technologies S.L.
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
BIO|MASTER.CSP Study
The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP).
- Conditions
- Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial, Cardiac Resynchronization Therapy Devices, Bradycardia
- Trial name
- NCT06620237
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 14 sites in Australia, Belgium and 3 more
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
Bradycardia, Conduction Block, Atrioventricular
LLL vs. SDL for LBBP: A Non-inferiority RCT
Left Bundle Branch Pacing (LBBP) has emerged as one of the most commonly used physiological pacing modalities in clinical practice.
- Trial name
- NCT07378124
- Testing
- SDL implantation, LLL implantation
- Where
- China
- Volunteers
- 288 people
- Sponsor
- Ningbo No.2 Hospital
Arrhythmia, Bradycardia
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival…
- Conditions
- Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia
- Trial name
- PPR (NCT00271180)
- Testing
- Device
- Where
- 333 sites in United States, Australia and 33 more
- Volunteers
- 20,000 people
- Sponsor
- Medtronic
Sick Sinus Syndrome, Complete Atrioventricular Block
Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation
This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to performing double-chamber pacemaker implantation.
- Conditions
- Sick Sinus Syndrome, Complete Atrioventricular Block, High Degree Second Degree Atrioventricular Block (Disorder), Bradycardia
- Trial name
- ZF-PMDC (NCT03118427)
- Testing
- zero-fluoroscopy 3D navigation, conventional x-ray navigation
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Tongji Hospital
Syncope
Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope
Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope.
- Trial name
- SYNCOPACED (NCT04229589)
- Testing
- Clinic follow-up
- Where
- 7 sites in Italy
- Volunteers
- 1,364 people
- Sponsor
- Azienda Ospedaliera Cardinale G. Panico
Bradycardia
Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker
The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.
- Trial name
- DREAM (NCT01537718)
- Testing
- REPLY 200
- Where
- 5 sites in France, Spain
- Volunteers
- 40 people
- Sponsor
- LivaNova
Pruritis, Hypotension Drug-Induced
Incidence of Pruritus Using Intrathecal Fentanyl Versus Epidural Fentanyl to Initiate Labour Analgesia.
The purpose of this study is to investigate the effect of neuraxial analgesia initiation on the incidence of pruritus in laboring women.
- Conditions
- Pruritis, Hypotension Drug-Induced, Urinary Retention, Fetal Bradycardia During Labor
- Trial name
- NCT07187427
- Testing
- Spinal analgesia, Epidural Analgesia
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- St. Justine's Hospital