Clinical trials: Bradyarrhythmias
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
Hypertension, Hypertension, Systolic
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure…
- Conditions
- Hypertension, Hypertension, Systolic, Hypertension, Essential
- Trial name
- BACKBEAT (NCT06059638)
- Testing
- Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated, Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
- Where
- 131 sites in United States, Australia and 13 more
- Volunteers
- 316 people
- Sponsor
- Orchestra BioMed, Inc
Bradycardia, Brady-tachy Syndrome
ALPs Single ChambEr New Device
Prospective, non-randomized, multi-center, international study designed to evaluate the initial safety and performance of the ALPS leadless pacemaker when used in patients with bradycardia.
- Conditions
- Bradycardia, Brady-tachy Syndrome, AV Block, Atrial Fibrillation (AF)
- Trial name
- ASCEND (NCT07461935)
- Testing
- Leadless ventricular pacemaker implantation
- Volunteers
- 10 people
- Sponsor
- Cairdac SA
Sinus Node Dysfunction
Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction
This is a noncommercial, physician-initiated, monitored, multicenter, prospective randomized clinical trial, a proof-of-concept study, investigating a treatment strategy only.
- Trial name
- SANOK (NCT05196126)
- Testing
- Permament pacemaker implantation, Cardioneuroablation
- Where
- 4 sites in Poland
- Volunteers
- 60 people
- Sponsor
- Stec, Sebastian, MD, PhD, FESC
Bradycardia, Tachycardia
Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems
This is a clinical investigational plan (CIP) for the "Clinical Study to Confirm MRI Safety and Effectiveness Using SJM Cardiac Rhythm Management Systems (ASSURE MRI)".
- Trial name
- ASSUREMRI (NCT03012568)
- Testing
- SJM Implantable cardiac devices
- Where
- 3 sites in Australia, India
- Volunteers
- 119 people
- Sponsor
- Abbott Medical Devices
Neonatal Bradycardia, Hypoxemia of Newborn
Bradycardia Recognition and Detection in Young Infants Part-I
This prospective cohort study will determine the diagnostic accuracy of the Owlet OSS 3.0 monitor for the detection of episodes of bradycardia and/or hypoxemia among infants.
- Trial name
- BRADY-I (NCT05774470)
- Testing
- Owlet OSS 3.0
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- University of Alabama at Birmingham
Bradyarrhythmia, Dyspnea
The Safety and Efficacy of FFR Protocol in NTUH System
FFR-guided PCI has been performed in National Taiwan University Hospital(NTUH) for many years. Nevertheless, the method of FFR measurement in NTUH is different from that in literature.
- Conditions
- Bradyarrhythmia, Dyspnea, Acute Respiratory Failure
- Trial name
- NCT03693157
- Where
- Taiwan
- Volunteers
- 250 people
- Sponsor
- National Taiwan University Hospital Hsin-Chu Branch
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.
Post-immunisation Apnoea and Bradycardia of Prematurity (AOP)
Predictive Value of Heart Rate Variability on Cardiorespiratory Events
The aim of this study are to investigate whether heart rate variability (HRV) parameters derived from nonlinear time series analysis at five different time points have prognostic utility for assessing the risk of postimmunisation…
- Trial name
- NCT04303494
- Testing
- immunisation
- Where
- Switzerland
- Volunteers
- 292 people
- Sponsor
- University Hospital, Basel, Switzerland
Bradycardia, Tachycardia
China 3T MRI Study
The purpose of the China CIED 3.0T MRI Performance Study is to confirm safety of SureScan CIED in the clinical 3.0T MRI environment when subjects receive MRI scans.
- Conditions
- Bradycardia, Tachycardia, Heart Failure
- Trial name
- NCT06038123
- Testing
- China market released 3.0T Magnetic resonance (MR) conditional CIED systems
- Where
- 5 sites in China
- Volunteers
- 64 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Neuromuscular Blockade
Reversal of Neuromuscular Blockade and Perioperative Arrhythmias
Patients scheduled for elective abdominopelvic laparoscopic surgery under general anesthesia were included. Rocuronium was used for the neuromuscular blockade (NMB) and the level of NMB was monitored with train-of-four (TOF)…
- Trial name
- NCT04720573
- Testing
- Neostigmine, Sugammadex
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Başakşehir Çam & Sakura City Hospital
Cardiac Pacemaker, Cardiac Rhythm Disorder
AVEIR Remote Care System Non-Significant Risk Study
The goal of the study is to understand the performance of the AVEIR Remote Care System in an initial patient cohort which will inform the ability to offer a remote follow-up solution to all patients implanted with Aveir LP…
- Conditions
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT06542133
- Testing
- AVEIR remote care system
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Heart Block, Bradycardia
iPod and Other MP3 Players on ICDs and Pacemakers in Children
Unlike phones, which are commonly held to the ear, music is now available via portable MP3 players and they can be held almost anywhere.
- Conditions
- Heart Block, Bradycardia, Tachycardia, Arrhythmia
- Trial name
- NCT00542854
- Testing
- MP3
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Children's Hospital
Bradycardia, Slow Heart Beat
EMRI SureScan™ Clinical Study
The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan…
- Trial name
- NCT00433654
- Testing
- Implantable Pulse Generator (IPG) and Pacing Leads (wires), Magnetic Resonance Imaging (MRI) scan
- Where
- 45 sites in United States, Austria and 9 more
- Volunteers
- 484 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia Sinus, AV Block
The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Echo, ECG
The goal of this observational study is to assess inter-/intra- ventricular synchrony and ECG characteristics in relation to Micra tip location.
- Conditions
- Bradycardia Sinus, AV Block, Atrial Fibrillation (AF)
- Trial name
- NCT06910059
- Testing
- Observational
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Spinal Anesthesia
Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Adult Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia
Patients undergoing lower extremity surgery with spinal anesthesia are often sedated to reduce patient discomfort due to large noises during surgery and also to reduce anxiety.
- Trial name
- NCT03322150
- Testing
- Atropine, Glycopyrrolate
- Where
- South Korea
- Volunteers
- 2 people
- Sponsor
- Yonsei University
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
Bradycardia, Heart Failure
Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
The study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt…
- Trial name
- NCT06018818
- Testing
- Amvia/Solvia pacemaker family
- Where
- 3 sites in Austria, Germany
- Volunteers
- 129 people
- Sponsor
- Biotronik SE & Co. KG
Bradycardia
ULTRA Study for Pacemaker Patients
The ULTRA study will assess the difference in average ventricular voltage output for pacemaker patients randomized to Automatic Capture feature ON versus patients randomized to Automatic Capture feature OFF.
- Trial name
- NCT00133289
- Testing
- Pacemaker with Automatic Capture
- Where
- United States
- Volunteers
- 950 people
- Sponsor
- Boston Scientific Corporation
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