Clinical trials: Heart Rate Low
Bradycardia, Sinus Node Dysfunction
Physiologic Pacing Registry
The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements…
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT03719040
- Testing
- Physiologic pacing device implant
- Where
- 50 sites in United States, Australia and 14 more
- Volunteers
- 870 people
- Sponsor
- Abbott Medical Devices
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
Heart Failure, Congestive
X-Change HF - Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure
The goal of X-Change HF is to estimate the effect of biventricular stimulation in patients who need antibradycardia ventricular stimulation (more than 80%); are eligible for the exchange of an old pacemaker or implantable…
- Trial name
- NCT00157846
- Testing
- CRT-P or CRT-D Device
- Where
- 10 sites in Germany
- Volunteers
- 36 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Syncope, Presyncope
Abbott Brady 3T MRI PMCF
The objective of this post-market, clinical follow up (PMCF) study, is to confirm the long-term safety of the Tendril STS and Isoflex leads, implanted with the Assurity MRI™ or Endurity MRI™ pacemakers, in patients undergoing a…
- Conditions
- Syncope, Presyncope, Fatigue, Disorientation
- Trial name
- NCT03786640
- Testing
- 3T MRI scan
- Where
- 9 sites in Estonia, France and 3 more
- Volunteers
- 3 people
- Sponsor
- Abbott Medical Devices
Bradycardia
SJM Brady MRI Post Approval Study
The purpose of this post approval study is to evaluate the long-term safety of the FDA approved St. Jude Medical Tendril MRI™ lead implanted with a SJM Brady MRI implantable pulse generator (IPG) such as the Accent MRI™, Assurity…
- Trial name
- Brady MRI PAS (NCT03170583)
- Testing
- St. Jude Medical Tendril MRI™ lead
- Where
- 66 sites in United States
- Volunteers
- 1,768 people
- Sponsor
- Abbott Medical Devices
Leadless Pacemaker, Bradycardia
BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
The objective of this Investigational Device Exemption trial is to confirm the safety and performance of the LivIQ leadless pacemaker system, in patients with a Class I or II indication for ventricular pacing (VVI/VDD) according…
- Conditions
- Leadless Pacemaker, Bradycardia, AV Block, Cardiac Rhythm Disorder
- Trial name
- BIO-LivIQ (NCT07118358)
- Testing
- LivIQ Leadless Pacemaker System
- Where
- 43 sites in United States, Australia and 6 more
- Volunteers
- 325 people
- Sponsor
- Biotronik, Inc.
Heart Failure, Bradycardia
Merlin Expanded ECG NSR
This clinical investigation is a prospective, single-arm, multi-center, observational study designed to evaluate the concordance between a simplified electrocardiogram (ECG) method implemented on the Merlin™ 3650 or MER3700…
- Trial name
- NCT07877805
- Testing
- Left Bundle Branch Implant
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Sudden Cardiac Arrest
Feasibility Study of Remote Support for Implantable Pulse Generator (IPG)/Implantable Cardioverter Defibrillator (ICD) Implant
The purpose of this study is to gain real world, live implant experience with the remote implant support system. This system is intended to provide the technical support for device implants from a remote location through…
- Trial name
- NCT01809652
- Testing
- Remote Implant Support Capability
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradyarrhythmia
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
The study objective is to collect mid-term clinical outcome in a group of patients implanted with permanent pacemaker (PM) according to real-life clinical practice in a multicenter and international environment.
- Trial name
- OPTI-MIND (NCT00976482)
- Where
- Germany
- Volunteers
- 1,745 people
- Sponsor
- Boston Scientific Corporation
Arrhythmia, Bradycardia
CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse
This study compares the pacemaker's automatic pacing threshold measurements to the manual measurements conducted by a health care provider.
- Trial name
- NCT00275769
- Testing
- Pacemaker
- Where
- 57 sites in United States, Canada
- Volunteers
- 860 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Sick Sinus Syndrome, Heart Failure, Congestive
SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction
SAVE PACe is a large, prospective, single-blinded, randomized clinical trial with the main objective to study the effect of unnecessary right ventricular apical pacing on the clinical outcome of time to development of persistent…
- Conditions
- Sick Sinus Syndrome, Heart Failure, Congestive, Atrial Fibrillation, Bradycardia
- Trial name
- SAVEPACe (NCT00284830)
- Testing
- Implantable Pulse Generators
- Where
- 67 sites in United States, Canada
- Volunteers
- 1,070 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia
SITELINE 2 Polyurethane
The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the SITELINE 2 Polyurethane pacing lead.
- Trial name
- NCT00180284
- Testing
- SITELINE 2 Polyurethane (pacing lead)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Tachycardia Atrial, Atrial Fibrillation
BIO|STREAM.ICM Obesity
The aim of the submodule study is to assess whether a high BMI may influence the sensing performance and the sECG quality of the BIOMONITOR.
- Conditions
- Tachycardia Atrial, Atrial Fibrillation, Syncope, Bradycardia
- Trial name
- NCT04198220
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Biotronik SE & Co. KG
Hypertension Resistant to Conventional Therapy, Bradycardia
Moderato System: A Double-Blind Randomized Trial Ver 1.1
The purpose of this double blind randomized study is the evaluation of the safety and efficacy of the Moderato System. The Moderato implantable pulse generator is indicated for patients who have hypertension and also require a…
- Conditions
- Hypertension Resistant to Conventional Therapy, Bradycardia, Atrioventricular Block
- Trial name
- NCT02837445
- Testing
- PHC ON, PHC OFF
- Where
- 12 sites in Austria, Belgium and 5 more
- Volunteers
- 70 people
- Sponsor
- BackBeat Medical Inc
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
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
Bradycardia, Congestive Heart Failure
The EASYTRAK EPI Clinical Investigation
The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.
- Trial name
- EASYTRAK EPI (NCT00158925)
- Testing
- EASYTRAK EPI lead
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Bradycardia
BlueSync Field Evaluation
The purpose of this field evaluation is to collect and evaluate information related to CareLink transmission compliance as well as patient perceived benefit of BlueSync™ and the health care provider perception of the value of…
- Trial name
- NCT03518658
- Testing
- Evaluation Group, Control Group (Historical)
- Where
- 20 sites in United States, France and 2 more
- Volunteers
- 257 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradyarrhythmia
Safety and Efficacy Study of IPG Patient With Home Monitoring
The number of patients with implantable pulse generator (IPG) has steadily increased in Japan causing increment in number of in office follow-ups and greater burden on many hospitals.
- Trial name
- NCT01523704
- Testing
- BIOTRONIK Home Monitoring System, BIOTRONIK Home Monitoring System with In-office Follow-up
- Where
- Japan
- Volunteers
- 1,327 people
- Sponsor
- Biotronik Japan, Inc.
Bradycardia
ENHANCE-Efficacy of the Presence of Right Ventricular Apical Pacing Induced Ventricular Dyssynchrony as a Guiding Parameter for Biventricular Pacing in Patients With Bradycardia and Normal Ejection Fraction
The purpose of this clinical project is to evaluate the efficacy of the presence of Right Ventricular Apical (RVA) pacing induced ventricular dyssynchrony as a guiding parameter for bi-ventricular pacing in patients with…
- Trial name
- ENHANCE (NCT01559311)
- Testing
- CRT-P OFF, CRT-P ON, DDDR
- Where
- 7 sites in Australia, China and 3 more
- Volunteers
- 98 people
- Sponsor
- Abbott Medical Devices