Clinical trials: Heart Rate Low
Pacemaker, Bradycardia
Adapta Pacing System Clinical Study
Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow).
- Trial name
- NCT00307073
- Testing
- Implantable Pulse Generator
- Where
- 7 sites in Austria, Czechia and 4 more
- Volunteers
- 120 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia
SALT - Success of Active Versus Passive Lead Fixation of Atrial Pacing/Sensing Electrodes
Randomised Comparison with regards to complication rate and electrical measurements of atrial leads with different fixation mechnism
- Trial name
- SALT (NCT00180570)
- Testing
- FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ
- Where
- Sweden
- Volunteers
- 385 people
- Sponsor
- Guidant Corporation
Atrial Fibrillation, Bradycardia
Study for Atrial Fibrillation Reduction (SAFARI)
Atrial fibrillation (AF), which is the name for rapid beats in the upper chambers of the heart, is the world's most common kind of irregular heart beat.
- Trial name
- NCT00267137
- Testing
- Pacing Algorithms
- Where
- 34 sites in United States
- Volunteers
- 540 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
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
Acute Myocardial Infarction (AMI), Asystole
SPIKE FLOW Endocardial Lead Safety and Performance Study
The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: safety in terms of freedom from Serious Adverse Events(SADEs); performance in terms of Mean…
- Conditions
- Acute Myocardial Infarction (AMI), Asystole, Bradycardia, AV Block
- Trial name
- SPIKE FLOW (NCT07820072)
- Testing
- Lead insertion, lead removal
- Where
- 3 sites in Italy
- Volunteers
- 131 people
- Sponsor
- FIAB SpA
Shortness of Breath Episode, Tachycardia
Verification of Prediction Algorithm
Prospective observational clinical study to verify an algorithm used to predict cardiopulmonary events in patients presenting to the emergency department.
- Conditions
- Shortness of Breath Episode, Tachycardia, Bradycardia, Difficulty Breathing
- Trial name
- VPAC (NCT02863666)
- Where
- 3 sites in United States, Belgium
- Volunteers
- 673 people
- Sponsor
- Zoll Medical Corporation
Bradycardia
Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.
This is an open label, interventional, feasibility, prospective, multicenter, clinical trial of lead extraction. The Xtrac O.S. system is intended for transvenous removal of pacing or defibrillator leads, having an inner lumen…
- Trial name
- XTR (NCT06115980)
- Testing
- lead extraction (Xtrac O.S. system)
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Xtrac O.S.
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
Arrhythmias, Cardiac, Bradycardia
One Hospital ClinicalService Project
The One Hospital ClinicalService Project is an integrated system composed by a network of International Hospital Departments, a clinical data repository and a shared environment for the collection, management, analysis and…
- Conditions
- Arrhythmias, Cardiac, Bradycardia, Syncope
- Trial name
- OHCS (NCT01007474)
- Testing
- Implantable Cardioverter-Defibrillator (ICD), Implantable Pacemaker Generator (IPG), Implantable Loop Recorder (ILR)
- Where
- 41 sites in Germany, Iceland and 7 more
- Sponsor
- Medtronic Italia
Cardiac Rhythm Disorder, Bradycardia
The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System
prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.
- Trial name
- NCT04559945
- Testing
- Aveir VR Leadless Pacemaker System
- Where
- 53 sites in United States, Canada and 6 more
- Volunteers
- 1,276 people
- Sponsor
- Abbott Medical Devices
Bradycardia
China Micra Transcatheter Pacing Study
The China Micra Transcatheter Pacing Study is a prospective, multi-center, single arm human clinical trial utilizing Objective Performance Criterion (OPC) to confirm the safety and efficacy profile of the Micra system for…
- Trial name
- NCT03624504
- Testing
- Micra Transcatheter Pacing System (TPS)
- Where
- 7 sites in China
- Volunteers
- 82 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Arrhythmias, Cardiac, Atrial Fibrillation
AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection
The study is a prospective single-arm multicenter clinical trial. Adult patients will be consented and enrolled in an outpatient cardiology office or Arrhythmia Clinics.
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Bradycardia
- Trial name
- VALID-ECG (NCT06123130)
- Testing
- Vectorcardiography (VECG)
- Where
- 5 sites in United States
- Volunteers
- 198 people
- Sponsor
- HeartBeam, Inc.
Sinus Bradycardia, Sinus Node Disease
IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.
- Conditions
- Sinus Bradycardia, Sinus Node Disease, Atrio-ventricular Block
- Trial name
- IES-ACap (NCT00832260)
- Volunteers
- 70 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacemaker, Arrhythmia
Aveir AR Coverage With Evidence Development (CED) Study
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).
- Conditions
- Cardiac Pacemaker, Arrhythmia, Bradycardia
- Trial name
- ARRIVE (NCT06100770)
- Testing
- Aveir AR Leadless Pacemaker, Single-chamber atrial transvenous pacemaker
- Where
- United States
- Volunteers
- 586 people
- Sponsor
- Abbott Medical Devices
Bradycardia; Sick Sinus Syndrome, AV Block
Efficacy of a Pacemaker Algorithm in Promotion of the Intrinsic Heart Activity.
The purpose of this study is to provide evidence that the Refined Ventricular Pacing Algorithm leads to clinically relevant reduction (at least 50% reduction) of the incidence of ventricular pacing.
- Trial name
- NCT00156741
- Testing
- Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2, Required pacemaker setting
- Where
- 30 sites in Austria, Czechia and 9 more
- Volunteers
- 150 people
- Sponsor
- Medtronic BRC
Ventricular Fibrillation, Ventricular Tachycardia
Left Ventricular Capture Management Study
Primary Objective: To characterize left ventricular (LV) threshold behavior over time using daily left ventricular capture management (LVCM) measurements.
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia, Bradyarrhythmia
- Trial name
- LEARN (NCT01089634)
- Where
- Canada
- Volunteers
- 151 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradyarrhythmia
Micra Accelerometer Sensor Study 2
The purpose of the MASS2 is to characterize accelerometer signals of Micra implantable device during different postures and activities and to understand the source of the sensed motion, in order to test feasibility for future…
- Trial name
- MASS2 (NCT02930980)
- Testing
- Investigational Software loaded on Micra device
- Where
- 4 sites in Austria, France and 1 more
- Volunteers
- 43 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Pacing
Model 4965 Post-Approval Study
Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).
- Conditions
- Heart Failure, Pacing, Bradycardia, Arrhythmia
- Trial name
- NCT01076348
- Where
- 107 sites in United States, Australia and 12 more
- Volunteers
- 73 people
- Sponsor
- Medtronic
Bradycardia, Left Bundle Branch Area Pacing
Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution
To evaluate the capability to monitor LBB success criteria with the use of a Smart ECG system (ECG monitor, 12 leads ECG cable, ECG viewer software ) during a cardiac device implantation involving the placement of a pacing lead…
- Conditions
- Bradycardia, Left Bundle Branch Area Pacing, Cardiac Resynchronisation Therapy (CRT), ECG
- Trial name
- LBBOT (NCT07254013)
- Testing
- LBBAP implant
- Where
- 4 sites in France
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- MicroPort CRM