Clinical trials: Bradycardia
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
Bradycardia, Cardiac Resynchronization Therapy
Safety and Performance Evaluation of a New Catheter Range for Lead Implantation at Interventricular Septum
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
- Conditions
- Bradycardia, Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing, Left Bundle Branch Pacing
- Trial name
- POLARIS (NCT06453850)
- Testing
- Use of FLEXIGO delivery catheter
- Where
- 17 sites in France, Germany and 3 more
- Volunteers
- 216 people
- Sponsor
- MicroPort CRM
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
Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction
The study is a prospective, randomized controlled study in hypertensive patients with a bradycardia indications for pacing therapy and a plan to receive dual-chamber pacemaker.
- Trial name
- NCT07589452
- Testing
- Personalized lower rate pacing, Standard lower rate pacing
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Arrhythmias, Cardiac, Tachycardia, Supraventricular
Cardiac Arrhythmias in Pediatric Emergency Department
This cross-sectional study aims to determine the incidence, clinical presentation, and outcome of cardiac arrhythmias among children presenting to the Emergency Department of Assiut University Children Hospital.
- Conditions
- Arrhythmias, Cardiac, Tachycardia, Supraventricular, Bradycardia
- Trial name
- NCT07826273
- Volunteers
- 73 people
- Sponsor
- Assiut University
Atrial Fibrillation, Tachycardia, Supraventricular
Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial
The clinical study is intended to implement and test the collection and analysis of paired ECG data from the HeartWatch and two comparator devices, an Event Recorder and Holter.
- Conditions
- Atrial Fibrillation, Tachycardia, Supraventricular, Bradyarrhythmia, Ventricular Arrythmia
- Trial name
- PRE-ALERT (NCT05357716)
- Testing
- HeartWatch, Event Recorder, Holter Monitor
- Where
- Canada
- Volunteers
- 7 people
- Sponsor
- HelpWear Inc.
Bradycardia, Arrhythmia
The Impact of Video-based Cardiac Rehabilitation Education in Patients With CIEDs
Cardiac rehabilitation has the beneficial effects of secondary prevention and social psychological and physical health status in patients with cardiovascular diseases.
- Conditions
- Bradycardia, Arrhythmia, Heart Failure
- Trial name
- CIEDs (NCT06503445)
- Testing
- education video
- Where
- Taiwan
- Volunteers
- 85 people
- Sponsor
- National Taiwan University Hospital Hsin-Chu Branch
Atrial Fibrillation (AF), Pulsed Field Ablation
Evaluation of the Factors Associated With BRADYcardia Following Pulmonary Vein Isolation Using Pulsed Field Ablation
The study aims to identify factors associated with bradycardia during the hospital stay after ablation of atrial fibrillation performed with pulsed field technology.
- Conditions
- Atrial Fibrillation (AF), Pulsed Field Ablation, Bradycardia
- Trial name
- BRADY-PFA (NCT07809347)
- Testing
- Pulmonary vein isolation
- Where
- Poland
- Volunteers
- 100 people
- Sponsor
- Wroclaw Medical University
Bradycardia, Atrioventricular Block
Procedural Endpoint in Left Bundle Branch Area Pacing: Conduction System Capture Versus LV Septal Capture
This is a prospective, multicenter, randomized controlled trial designed to determine whether direct capture of the left ventricular conduction system must be achieved as the procedural endpoint of left bundle branch area pacing…
- Conditions
- Bradycardia, Atrioventricular Block, Sick Sinus Syndrome, Cardiac Pacing
- Trial name
- COMPARE-SYNC (NCT07804394)
- Testing
- LBBAP with mandatory left ventricular conduction system capture (LBBP or LFP), LBBAP with left ventricular septal capture as the accepted procedural endpoint (LVSP)
- Volunteers
- 300 people
- Sponsor
- Yonsei University
Bradycardia, Heart Block
Transjugular Approach for Implantation of Active Fixation Leadless Pacemakers
This study is a prospective, single-arm, single-center feasibility study evaluating the safety and feasibility of transjugular (internal jugular vein) implantation of the Aveir VR leadless ventricular pacemaker in patients…
- Conditions
- Bradycardia, Heart Block, Sick Sinus Syndrome, Atrioventricular Block
- Trial name
- NCT07802119
- Testing
- Aveir VR Leadless Pacemaker
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Min Shen
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
Intraoperative Bradycardia
Treating Intraoperative Bradycardia in Non-cardiac Surgery Patients With Atropine at Heart Rates Below 60 Versus 30 Beats Per Minute and Norepinephrine Requirements
The RAPID trial is a randomized, single-center trial investigating whether giving atropine at heart rates below 60 beats per minute versus giving atropine only at heart rates below 30 beats per minute reduces the amount of…
- Trial name
- RAPID (NCT06922097)
- Testing
- Giving atropine at heart rates below 60 beats per minute, Giving atropine at heart rates below 30 beats per minute
- Where
- Germany
- Volunteers
- 186 people
- Sponsor
- University of Hamburg-Eppendorf
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
Bradycardia
Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer
The purpose of this study is to collect and compare the heart's electrical activity data measured by the novel Conduction System Pacing (CSP) Display Research System with data measured via 12 lead electrocardiogram (ECG) from a…
- Trial name
- CSP Display (NCT07733960)
- Testing
- CSP Display research system
- Where
- 2 sites in India
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Premature Birth, Fragility
Wireless MicroPremVitals Button Sensor in the NICU
A wireless and miniaturized vital sign (ECG, SpO2, Skin Temperature) sensor system, MicroPremVitals Button Sensors was developed by the Dr.
- Conditions
- Premature Birth, Fragility, Apnea of Prematurity, Bradycardia Neonatal
- Trial name
- NCT07732257
- Testing
- Wireless MicroPremVitals Button Sensor System
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Bradycardia, Pacing
"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)
The PROTECT-HF multi-centre randomised controlled trial will compare two different pacing approaches for treating patients with slow heart rates.
- Conditions
- Bradycardia, Pacing, Right Ventricular Pacing, His Bundle Pacing
- Trial name
- PROTECT-HF (NCT05815745)
- Testing
- Pacemaker - Physiological pacing, Pacemaker - Right Ventricular pacing
- Where
- 45 sites in Ireland, Slovenia and 1 more
- Volunteers
- 2,600 people
- Sponsor
- Imperial College London
Heart Rate Monitoring, Vagal Bradycardia
Heart Rate Variability and Early Cytokine Profile in Pediatric Adenotonsillectomy
This prospective observational cohort study will assess whether perioperative short-term heart rate variability (HRV) indices and early inflammatory cytokine levels are associated with respiratory and cardiac adverse events in…
- Conditions
- Heart Rate Monitoring, Vagal Bradycardia, Adenotonsillar Hypertrophy, Tonsillitis; Hypertrophic
- Trial name
- NCT07719439
- Where
- Turkey (Türkiye)
- Volunteers
- 76 people
- Sponsor
- Duzce University
Atrial Fibrillation, Atrial Flutter
HeartBeam ECG Registry
The HeartBeam ECG Registry will collect ECG recordings acquired with the HeartBeam System with relevant clinical information in clinical settings.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Bradycardia, Tachycardia
- Trial name
- NCT07501299
- Testing
- Electrocardiogram (ECG)
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- HeartBeam, Inc.
Sinus Node Dysfunction, Bradycardia
BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S
The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia CSP S pacing lead when implanted in the left bundle branch area (LBBA).
- Conditions
- Sinus Node Dysfunction, Bradycardia, Atrioventricular Block
- Trial name
- BIO-CONDUCT (NCT06540079)
- Testing
- Solia CSP S lead
- Where
- 10 sites in United States
- Volunteers
- 192 people
- Sponsor
- Biotronik, Inc.
Bradycardia, Syncope, Vasovagal
Comparison of Focal Cryoablation vs. Radiofrequency Cardioneuroablation for Bradyarrhythmias
Bradyarrhythmias are conditions where the heart beats too slowly, causing symptoms like dizziness, fainting, and fatigue. In some patients, these slow heart rhythms are caused by overactivity of the vagus nerve (the part of the…
- Conditions
- Bradycardia, Syncope, Vasovagal, Sick Sinus Syndrome, Atrioventricular Block
- Trial name
- CRYO-CNA vs RF (NCT07671898)
- Testing
- Focal Cryoablation, Radiofrequency Catheter Ablation
- Where
- Russia
- Volunteers
- 60 people
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences