Clinical trials: Bradyarrhythmias
Bradycardia, Strabismus
The Alaska Oculocardiac Reflex Study
Observation study monitoring vital signs and anesthetic variables particularly heart rate during prospective, ocular manipulation and specifically uniform tension on extra ocular muscles during strabismus surgery.
- Trial name
- AK-OCR (NCT04353960)
- Testing
- electrocardiograph
- Where
- United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- Alaska Blind Child Discovery
Hematoma Intracranial, Hydrocephalus
Subgaleal Drains in Decompressive Craniectomies
This research is about the use of subgaleal drains to prevent accumulation of blood under the skin in patients undergoing surgery to remove part of the skull(craniectomy) and its associated complications.
- Conditions
- Hematoma Intracranial, Hydrocephalus, Surgical Site Infection, Wound Breakdown
- Trial name
- VADER (NCT03777774)
- Testing
- Passive Redon subgaleal drains, Vacuum Redon subgaleal drains, No Redon subgaleal drains
- Where
- 2 sites in Malaysia
- Volunteers
- 78 people
- Sponsor
- Universiti Sains Malaysia
Bradycardia, Atrial Fibrillation
Atrial Pacing for Termination and Prevention of Atrial Fibrillation
Atrial fibrillation (AF) is the most common sustained arrhythmia and is associated with substantial morbidity and mortality. Present treatment strategies are aimed at termination of AF and prevention of AF recurrence using…
- Trial name
- NCT00123344
- Testing
- AT501 pacemaker
- Where
- Canada
- Volunteers
- 120 people
- Sponsor
- University of Calgary
Intermittent Hypoxemia, Apnea of Prematurity
Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants
In this randomized crossover trial, preterm infants with intermittent hypoxemia and need for supplemental oxygen will be randomized to either Sequence of two different oxygen target ranges (low: 85-89%; high: 91-95%) for a total…
- Trial name
- NCT02743988
- Testing
- Oxygen
- Where
- Germany
- Volunteers
- 36 people
- Sponsor
- University of Ulm
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
Atrial Fibrillation, Heart Rate Fast
Portable Measurement Methods Combined With Artificial Intelligence in Detection of Atrial Fibrillation
In Western countries, every sixth person in their lifetime and 15,000 people in Finland have a new stroke each year. About every fourth stroke is based on cardiac embolism.
- Conditions
- Atrial Fibrillation, Heart Rate Fast, Heart Rate Low, Sinus Rhythm
- Trial name
- WB-AF (NCT04917653)
- Testing
- Heart rhythm monitoring with wearable device, Blood samples and biomarkers
- Where
- Finland
- Volunteers
- 100 people
- Sponsor
- Kuopio University Hospital
Bradycardia, Remote Monitoring
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
The purpose of the clinical investigation is to document the safety and the performances of the remote monitoring functions of the ALIZEA, BOREA and CELEA pacemakers, i.e. the RAAT, the RVAT and the remote alerts.
- Trial name
- CALLIOPE (NCT05165095)
- Testing
- Pacemaker implantation
- Where
- 19 sites in Austria, Belgium and 6 more
- Volunteers
- 206 people
- Sponsor
- MicroPort CRM
Arrhythmia, Bradycardia
MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY
The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices.
- Trial name
- NCT01076374
- Where
- 129 sites in United States, Austria and 10 more
- Volunteers
- 2,927 people
- Sponsor
- Medtronic
Bradycardia
Falls and Cardiovascular Events in Pacemaker Patients
The purpose of this study is to document the number of falls and fractures in Sinus Node Disease (SND) patients.
- Trial name
- NCT01037426
- Testing
- Fill out Questionnaire
- Where
- 8 sites in Switzerland
- Volunteers
- 87 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradyarrhythmias
Outcome of Patients Undergoing Leadless Pacemaker Implantaton
Observational study aimed to evaluate the rate and of complications related to lealdless pacemaker implantation.
- Trial name
- OPUPI (NCT06656468)
- Testing
- Pacemaker and defibrillator
- Where
- Italy
- Volunteers
- 900 people
- Sponsor
- Azienda Ospedaliera Cardinale G. Panico
Bradycardia, Sinus Node Dysfunction
ImageReady(TM) MR Conditional Pacing System Clinical Study
The objective of the SAMURAI Clinical Study is to collect data to confirm the safety, performance and effectiveness of the ImageReady System for use in the Magnetic Resonance Imaging (MRI) environment when used in accordance with…
- Trial name
- SAMURAI (NCT01781078)
- Testing
- MRI, ImageReady System implant
- Where
- 41 sites in United States, Australia and 5 more
- Volunteers
- 363 people
- Sponsor
- Boston Scientific Corporation
Bradycardia, Tachycardia, Ventricular
Fluoroscopy Reduction or Elimination in CIED Implants
CIED implants require different amounts of fluoroscopy; using 3-D mapping systems, these times could be reduced to near zero fluoroscopy.
- Conditions
- Bradycardia, Tachycardia, Ventricular, Heart Failure
- Trial name
- NCT04919733
- Testing
- Fluoroscopy reduction
- Where
- Canada
- Volunteers
- 150 people
- Sponsor
- Université de Sherbrooke
Bradycardia, Left Bundle Branch Area Pacing
Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Septum
The purpose of the clinical investigation is to evaluate the safety and performances of the new LINEA cardiac pacing lead, intended for placement at the interventricular septum.
- Conditions
- Bradycardia, Left Bundle Branch Area Pacing, Left Bundle Branch Pacing
- Trial name
- STARLIGHT (NCT07342608)
- Testing
- Use of LINEA cardiac pacing lead
- Where
- 14 sites in Belgium, France and 3 more
- Volunteers
- 450 people
- Sponsor
- MicroPort CRM
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
Bradycardia, Right Ventricular Pacing
Left Bundle Branch Area Pacing (LBBAP) PMCF Study
The objective of this study is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients implanted with the Tendril STS 2088TC or UltiPace LPA1231 lead through 6 months post-implant.
- Conditions
- Bradycardia, Right Ventricular Pacing, Heart Failure, Atrial Fibrillation (AF)
- Trial name
- LBBAP PMCF (NCT07217392)
- Testing
- LBBAP lead
- Where
- 15 sites in Brazil, France and 7 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Apnea of Prematurity
Apnea Treatment in Premature Infants Using an Automatic Vibro-tactile Stimulator Triggered by the Detection of Apnea-bradycardia.
The goal of the SENSITACT system is to activate an adaptive kinesthetic stimulation to treat apnea-bradycardia events on preterm infants, while minimizing deleterious effects, in particular arousals that can be due either to…
- Trial name
- SENSITACT (NCT03651648)
- Testing
- SENSITACT System
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Rennes University Hospital
Hypertension Resistant to Conventional Therapy, Bradycardia
Safety and Performance Study of the Moderato System
The purpose of the study is to evaluate the safety and performance of the Moderato System by implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who also have hypertension, in order to reduce…
- Conditions
- Hypertension Resistant to Conventional Therapy, Bradycardia, Atrioventricular Block
- Trial name
- NCT02282033
- Testing
- The Moderato System
- Where
- 10 sites in Austria, Chile and 5 more
- Volunteers
- 57 people
- Sponsor
- BackBeat Medical Inc
Atrial Fibrillation (AF), Atrial Premature Complexes
Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System
The goal of this clinical trial is to evaluate the safety and efficacy of medical device Kardi Ai, an ECG telemetry monitoring device in adult population.
- Conditions
- Atrial Fibrillation (AF), Atrial Premature Complexes, Ventricular Premature Complexes, Bradycardia
- Trial name
- Kardi Ai (NCT07018648)
- Testing
- Medical device
- Where
- 2 sites in Czechia
- Volunteers
- 115 people
- Sponsor
- KARDI AI Technologies s.r.o.
Bradycardia
Reduction of Right Ventricular Pacing Using the Feature Ventricular Intrinsic Preference (VIP)
The purpose of this study is to evaluate the efficacy of the VIP™ feature (available in dual chamber Victory® devices) to reduce unnecessary RV pacing, and to determine if patients with implanted SJM pacemakers will benefit by…
- Trial name
- NCT00311168
- Testing
- Intervention/treatment
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- Abbott Medical Devices
Arrhythmias, Cardiac, Atrioventricular Block
ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing
The goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical…
- Conditions
- Arrhythmias, Cardiac, Atrioventricular Block, Reduced Systolic Function, Atrial Fibrillation
- Trial name
- TREEBEARD (NCT06324682)
- Testing
- Cardiac pacing - Conventional RV pacing, Cardiac pacing - Conduction System Pacing, Cardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD)
- Where
- 31 sites in Italy
- Volunteers
- 8,400 people
- Sponsor
- University Hospital of Ferrara