Clinical trials: Bradycardia
Arrhythmias, Cardiac, Bradycardia
Cardiac Implantable Electronic Device (CIED) Research Study
The study is designed to collect data on Cardiovascular Implantable Electronic Device (CIED) information, implant procedure details, and/or patient characteristics to support development of future CIED products and procedures.
- Conditions
- Arrhythmias, Cardiac, Bradycardia, Tachycardia
- Trial name
- NCT05061862
- Testing
- cardiac implantable electronic devices (CIEDs)
- Where
- 9 sites in United States, Belgium
- Volunteers
- 1,000 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Bradycardia
Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System
The purpose of this study is to report the stability of atrial and ventricular leads by absence of effect of the MRI exam on the pacing and sensing threshold and to report the safety based on the serious adverse events.
- Trial name
- IKONE (NCT02175797)
- Testing
- MRI
- Where
- France
- Volunteers
- 33 people
- Sponsor
- MicroPort CRM
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
Bradycardia, Chronotropic Incompetence
Common Sensing and Right Ventricular Automatic Capture (COGNATE)
This study will collect data on features for future pacemakers via an external non-implantable system.
- Trial name
- COGNATE (NCT01030705)
- Where
- 5 sites in United States
- Volunteers
- 80 people
- Sponsor
- Boston Scientific Corporation
Bradycardia
Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers
The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices.
- Trial name
- Micra CED (NCT03039712)
- Where
- United States
- Volunteers
- 37,000 people
- Sponsor
- Medtronic
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
Clinical Investigation of the SelectSecure Pacing Lead
People who have a slow heart beat, or whose heart does not beat on its own, may be in need of an electronic device called a pacemaker. A pacemaker is implanted surgically just under the skin in the upper chest area.
- Trial name
- NCT00266682
- Testing
- Pacing Lead
- Where
- 31 sites in United States, Australia and 1 more
- Volunteers
- 365 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia
An Exploratory Safety and Efficacy Clinical Study of CARDIX-101 for the Treatment of Chronic Bradycardia
The treatment of chronic bradycardia, one of the cardiovascular diseases, remains an essential unsolved issue. The objective of this project is to speed up a new drug CARDIX-101 clinical Phase 1IA trial for the treatment of…
- Trial name
- NCT05117346
- Testing
- CARDIX-101A, CARDIX-101B, CARDIX-101C
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Cardix Therapeutics LLC
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
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
Arrhythmias, Cardiac, Atrial Fibrillation
Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation (First-in-Human Study)
This study is a first-in-human, prospective, multi-center, pre-market single-arm clinical trial to evaluate the Future Cardia™ ICM.
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation, Bradycardia, Ventricular Tachycardia
- Trial name
- NCT06167434
- Testing
- Future Cardia™ Insertable Cardiac Monitoring (ICM) System
- Where
- Croatia
- Volunteers
- 30 people
- Sponsor
- Future Cardia, Inc
Pacemaker, Artificial, Bradycardia
Evaluate the Benefits of Pacemaker Follow-Up With Home-Monitoring
The study investigates whether home monitoring follow-up of Pace-Maker patients is as efficient as conventional method in terms of Significant Serious Adverse Event (SSAE).
- Trial name
- COMPAS (NCT00989326)
- Testing
- Home Monitoring
- Where
- France
- Volunteers
- 543 people, healthy volunteers welcome
- Sponsor
- Biotronik France
Bradycardia, Atrial Fibrillation
Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation
Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with optimized pacemaker programming.
- Trial name
- PAFOS (NCT01912326)
- Testing
- Pacemaker Implantation
- Where
- Germany
- Volunteers
- 249 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
Accent MRI Pacemaker and Tendril MRI Lead New Technology Assessment
The intent of this study is to evaluate the performance of the implanted Accent MRI TM system in a clinical setting and optionally in the MRI environment. This system includes the St.
- Trial name
- NCT01258218
- Testing
- Implantation of an Accent MRI device
- Where
- Austria
- Volunteers
- 78 people
- Sponsor
- Abbott Medical Devices
Bradycardia
Micra Transcatheter Pacing System Continued Access Study Protocol
Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to the Micra System while the marketing application is under review by the Food and Drug Administration (FDA).
- Trial name
- NCT02488681
- Testing
- Micra Pacemaker Implant
- Where
- 29 sites in United States
- Volunteers
- 285 people
- Sponsor
- Medtronic
Sick Sinus Syndrome, Heart Block
Virtual Clinic Pacemaker Follow-up
Patients with implanted pacemakers are currently seen by their cardiologists every 6-12 months. Shorter follow-up intervals are generally seen as excessive workload for the physician, with little benefit for the patient.
- Conditions
- Sick Sinus Syndrome, Heart Block, Bradycardia
- Trial name
- VIRTUE (NCT00475124)
- Testing
- Home Monitoring of pacemaker, Home Monitoring of pacemaker deactivated
- Where
- 6 sites in United Kingdom
- Volunteers
- 123 people
- Sponsor
- Biotronik SE & Co. KG
Arrhythmia, Atrial Fibrillation
The Atrial High Rate Episodes in Pacemaker Patients
Prospective study assessing the incidence of atrial high rate episodes (AHRE) in pacemaker patients with and without previously diagnosed AT.
- Conditions
- Arrhythmia, Atrial Fibrillation, Atrioventricular Block, Bradycardia
- Trial name
- NCT00627328
- Where
- 42 sites in United States, Australia and 1 more
- Volunteers
- 427 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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.