Clinical trials: Bradyarrhythmias
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
INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study
The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.
- Trial name
- NCT04346537
- Testing
- INGEVITY+™ Pace/Sense Lead
- Where
- 13 sites in United States
- Volunteers
- 109 people
- Sponsor
- Boston Scientific Corporation
Sick Sinus Syndrome, Complete Atrioventricular Block
Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-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 single-chamber pacemaker implantation.
- Conditions
- Sick Sinus Syndrome, Complete Atrioventricular Block, High Degree Second Degree Atrioventricular Block, Bradycardia
- Trial name
- ZF-PMSC (NCT03118440)
- Testing
- zero-fluoroscopy 3D navigation, conventional x-ray navigation
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Tongji Hospital
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
Fetal Bradycardia Complicating Labor and Delivery, Fetal Bradycardia During Labor
Oxytocin and Fetal Heart Rate Changes
The reported risk of nonreassuring fetal heart trace following neuraxial analgesia is 3-23%. This variability may be due to fluid and oxytocin management prior to and during the initiation of neuraxial analgesia.
- Conditions
- Fetal Bradycardia Complicating Labor and Delivery, Fetal Bradycardia During Labor, Fetal Heart Rate or Rhythm Abnormality Affecting Fetus
- Trial name
- NCT03232918
- Testing
- Half dose Oxytocin
- Where
- 2 sites in United States
- Volunteers
- 730 people, healthy volunteers welcome
- Sponsor
- Unyime Ituk
Tachycardia, Atrial Fibrillation
Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up.
- Conditions
- Tachycardia, Atrial Fibrillation, Syncope, Bradycardia
- Trial name
- BIOSTREAM-ICM (NCT04075084)
- Where
- 31 sites in Australia, Czechia and 7 more
- Volunteers
- 1,400 people
- Sponsor
- Biotronik SE & Co. KG
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
Bradycardia, Heart Failure
BIO|CONCEPT.Amvia Study
The goal of this exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P)…
- Trial name
- NCT05610176
- Testing
- Amvia Sky pacemaker or CRT-P device
- Where
- 7 sites in Australia, New Zealand
- Volunteers
- 52 people
- Sponsor
- Biotronik Australia Pty Ltd.
Bradycardia, Heart Failure
His Bundle Pacing in Bradycardia and Heart Failure
Participants in this study will either have heart failure (HF) and are scheduled to undergo pace maker (PM) implantation, cardiac resynchronization therapy pacemaker (CRT-P), cardiac resynchronization therapy defibrillator…
- Trial name
- NCT03008291
- Testing
- CRT-D Implantation, CRT-P Implantation, Dual Chamber Pacemaker Implantation
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Yong-Mei Cha
Atrial Fibrillation, Syncope
Remote Symptom Review in Patients With Implantable Diagnostic Holter
To study the clinical and organizational benefit of implementing a methodology for monitoring patients receiving an implantable diagnostic BIOMONITOR III holter and successive models, consisting of remote review of alerts sent by…
- Conditions
- Atrial Fibrillation, Syncope, Bradycardia, Arrythmia
- Trial name
- BIOMONI-DIG (NCT06431828)
- Testing
- APP
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Andres Iñiguez Romo
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.
Implantable Loop Recorder
Bradycardia Risk Stratification With Loop Recorder After Syncope
Syncope is a common symptom that may be related to a conductive disorder. If no bradycardia is authenticated, it is often necessary to implant an implantable loop recorder.
- Trial name
- NCT04200014
- Where
- France
- Volunteers
- 250 people
- Sponsor
- Central Hospital, Nancy, France
Bradycardia
Safety and Electrical Performances of XFINE Leads
The purpose of the study is to confirm the safety and the electrical performances of the XFINE passive pacing leads, for both right ventricular (RV) straight models and right atrial (RA) J-shape models, up to 12 months follow-up…
- Trial name
- PERSEPOLIS (NCT03922386)
- Testing
- XFINE leads
- Where
- 19 sites in France, Italy and 3 more
- Volunteers
- 188 people
- Sponsor
- MicroPort CRM
Anesthesia
Study of Use of Dexmedetomidine for Regional Anesthesia
The purpose of this study is to find out the proper amount of a drug called dexmedetomidine added to the local anesthetic drug called lidocaine to prolong the time and effect of pain relief provided for surgery.
- Trial name
- NCT01969903
- Testing
- Precedex injection
- Sponsor
- NYU Langone Health
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, Sinus Node Dysfunction
LBBAP Data Collection Registry
The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT05887323
- Testing
- Implantation of the Tendril 2088 lead in the LBBA
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 221 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacing in Adherence With ESC Cardiac Pacing Guidelines
AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region (PREMIER LEADLESS)
The AVEIR™ Leadless Pacemaker Registry (herein referred to as "PREMIER LEADLESS Registry") is a prospective, multicenter, International, open label observational study designed to evaluate safety and electrical performances of…
- Trial name
- NCT06782152
- Volunteers
- 1,698 people
- Sponsor
- King Fahad Armed Forces Hospital
Prematurity, Respiratory Distress Syndrome
CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure
This study seeks to determine if standard continuous positive airway pressure, known as CPAP is as effective as a more complicated approach that generates intermittent increases in airway pressure applied to the nostrils via a…
- Conditions
- Prematurity, Respiratory Distress Syndrome, Apnea of Prematurity
- Trial name
- NICA (NCT03670732)
- Testing
- continuous positive airway pressure, nasal intermittent positive pressure ventilation
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Women and Infants Hospital of Rhode Island
Bradycardia
Cardiac Synchronization and Tricuspid Regurgitation With Leadless Pacemaker
Comparison of cardiac synchronization and tricuspid regurgitation with or without leadless pacemaker pacing in different site
- Trial name
- MICRA-SYNK (NCT05817695)
- Testing
- Leadless pacemaker
- Where
- China
- Volunteers
- 40 people
- Sponsor
- First People's Hospital of Hangzhou
Bradycardia
SCANCAP Scandinavian Automatic Capture Study
The primary objective of this study is to document the success rate of the automatic threshold testat pre-discharge in a normal pacemaker patient population implanted with Guidant Insignia Ultra or AVT .
- Trial name
- NCT00180609
- Testing
- Automatic threshold test in Insignia Pacemakers from Guidant
- Where
- Denmark
- Volunteers
- 203 people
- Sponsor
- Guidant Corporation