Clinical trials: Heart Rate Low
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
Platelet Aggregation, Blood Transfusion
Validation of a Red Blood Cell Transfusion Prediction Model in a Low Transfusion Rate Population.
The transfusion risk and clinical knowledge (TRACK) allogeneic blood transfusion prediction model was developed more than ten years ago and demonstrated good discriminative ability in patients with increased risk for allogeneic…
- Trial name
- TRACK-TCT (NCT05581238)
- Testing
- TRACK-TCT
- Where
- Netherlands
- Volunteers
- 6,428 people, healthy volunteers welcome
- Sponsor
- Medisch Spectrum Twente
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
Pain Management
LASER Effects Blood Flow
This study investigate the potential impact of low power laser (LPL), an non-invasive physical therapy, on the cardiovascular system by focusing on its effect on heart rate and autonomic tone.
- Trial name
- LASERBF (NCT07369843)
- Testing
- physical therapy (low power LASER)
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Saint Paul's Hospital, Congregation Of The Sisters Of Saint Paul De Chartres
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
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
Premature Infant, Extremely Low Birth Weight
Time to Accurate Heart Rate on Neonatal Outcomes
The goal of this trial is to compare the time to first heart rate displayed for iRes Warmer with ResusView and using iRes Warmer without ResusView when used in the resuscitation (e.g.
- Conditions
- Premature Infant, Extremely Low Birth Weight, Extreme Prematurity
- Trial name
- GE-EKG (NCT04587934)
- Testing
- iRes Warmer with ResusView, iRes Warmer without ResusView
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Sharp HealthCare
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
Chronic Kidney Disease, Cardiac Disease
Low Dose Continuous Furosemide Effect on Cardiac Surgery Patients With Kidney Dysfunction
Chronic kidney disease is an independent risk factor for cardiovascular disease associated with increased mortality rate during cardiac surgery in proportion to the kidney function.
- Trial name
- NCT04919564
- Testing
- Furosemide in 0.9 % NaCl 100 Mg/100 mL (1 mg/mL), NaCl 0.9%
- Where
- Indonesia
- Volunteers
- 90 people
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
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