Clinical trials: Pacemakers, Heart Failure
Chronic Heart Failure, Atrial Fibrillation
The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients.
To examine the effects of heart rate reduction on exercise capacity in control subjects and patients with chronic heart failure.
- Conditions
- Chronic Heart Failure, Atrial Fibrillation, Arrhythmia, Sinus
- Trial name
- TREPPE (NCT02247245)
- Testing
- Ivabradine, Atrial fibrillation
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- University of Leeds
Heart Failure With Reduced Ejection Fraction
Respiratory Sinus Arrhythmia (RSA) Pacing Post-CABG Surgery in Patients With HFrEF
The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation.
- Trial name
- RSA-PACE (NCT06359938)
- Testing
- Atrial pacing with respiratory sinus arrhythmia (RSA) variability, Monotonic right atrial overdrive pacing
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Ceryx Medical Ltd
Atrial Fibrillation, Stroke
TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics
The purpose of this study is to look at the heart rate and rhythm information collected daily in Medtronic implantable pulse generators (IPG), implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy…
- Conditions
- Atrial Fibrillation, Stroke, Heart Failure
- Trial name
- NCT00279981
- Testing
- Diagnostic
- Where
- 98 sites in United States, Australia and 1 more
- Volunteers
- 3,100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Arrhythmia, Bradycardia
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival…
- Conditions
- Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia
- Trial name
- PPR (NCT00271180)
- Testing
- Device
- Where
- 333 sites in United States, Australia and 33 more
- Volunteers
- 20,000 people
- Sponsor
- Medtronic
Heart Failure
Targeted Left Ventricular Lead Placement, Comparison of Active Fixation Bipolar and Passive Quadripolar Pacemaker Leads
A prospective, randomized and patient-blinded trial comparing an active fixation left ventricular lead with quadripolar passive left ventricular leads.
- Trial name
- NCT04632472
- Testing
- Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy
- Where
- Norway
- Volunteers
- 62 people
- Sponsor
- Haukeland University Hospital
Heart Failure
Implant of the WiSE CRT System With an Intracardiac Pacemaker
This study is a single arm, prospective, feasibility, multi-centre, observational study. Participants will be suitable for a Cardiac Resynchronisation Therapy (CRT) implant using Wireless Stimulation Endocardially for Cardiac…
- Trial name
- TLC (NCT05451797)
- Testing
- Implant of WiSE-CRT with intracardiac pacemaker
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Sick Sinus Syndrome, Pacemaker
Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber Pacemaker
The recent study using IRSplus and VpS algorithm from Biotronik pacemaker showed the significant reduction in ventricular pacing to less than 3%.
- Conditions
- Sick Sinus Syndrome, Pacemaker, Heart Failure
- Trial name
- LEADER (NCT03843242)
- Testing
- Pacemaker with Fixed long AV delay, Pacemaker with VpS® algorithm on, Pacemaker with IRSplus algorithm on
- Where
- 6 sites in South Korea
- Volunteers
- 146 people
- Sponsor
- Keimyung University Dongsan Medical Center
Sick Sinus Syndrome
Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)
The purpose of this study is to determine the incidence of atrial fibrillation and heart failure in patients with pacemaker therapy with different pacing modes (AAI, DDD, and a novel algorithm to minimize ventricular pacing).
- Trial name
- NCT00161551
- Testing
- Vitatron T70 DR
- Where
- 5 sites in Germany
- Volunteers
- 402 people
- Sponsor
- Medtronic BRC
Myocardial Infarction (MI), Pacemaker Implantation
Augmented Reality as Discharge Information for Hospitalized Cardiology Patients
The goal of this clinical trial is to find out whether a simple augmented reality tool provided at hospital discharge can improve patients' understanding of their care, adherence to treatment, and health outcomes, compared with…
- Conditions
- Myocardial Infarction (MI), Pacemaker Implantation, Heart Failure, Atrial Fibrillation (AF)
- Trial name
- RACAR (NCT07399379)
- Testing
- Augmented reality app
- Where
- Spain
- Volunteers
- 303 people
- Sponsor
- Hospital Universitario Getafe
Tachycardia, Ventricular, Heart Failure, Congestive
OMNI Study--Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices.
The purpose of the OMNI study is to characterize therapy and diagnostic utilization in study participants implanted with study devices and to describe Implantable Cardioverter Defibrillator(ICD)therapy utilization for life…
- Conditions
- Tachycardia, Ventricular, Heart Failure, Congestive, Ventricular Fibrillation, Ventricular Dysfunction
- Trial name
- OMNI (NCT00277524)
- Where
- 113 sites in United States
- Volunteers
- 3,032 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cognitive Impairment, Cognitive Change
How is COGNItive Function Affected by Cardiac Resynchronisation Therapy?
The primary objective of COGNI-CRT is to assess whether Cardiac Resynchronisation Therapy (CRT) can improve cognitive function in patients with systolic HF (LVEF ≤35%), when compared to a control group of patients implanted with…
- Conditions
- Cognitive Impairment, Cognitive Change, Heart Failure, Systolic, Heart Failure
- Trial name
- COGNI-CRT (NCT03755570)
- Testing
- Repeatable Assessment of Neuropsychological Status, Hospital Anxiety and Depression Scale, Frontal Assessment Battery
- Where
- United Kingdom
- Volunteers
- 198 people
- Sponsor
- Royal Cornwall Hospitals Trust
Bradyarrhythmia, Pacemaker Syndrome
Bi-ventricular Epicardial Activation in Left Bundle Area Pacing: a Comparison Study
Study of the ventricular activation patterns during left bundle area pacing and compare it with baseline activation during normal sinus rhythm in patients with and without baseline bundle branch conduction disorder.
- Conditions
- Bradyarrhythmia, Pacemaker Syndrome, Biventricular Cardiac Pacemaker Malfunction
- Trial name
- LBBAP (NCT05401851)
- Testing
- Left Bundel Area Pacing
- Where
- Belgium
- Volunteers
- 30 people
- Sponsor
- Universitair Ziekenhuis Brussel
Heart Failure, Pacemaker
OPTimising a Screening Program to Detect Pacemaker-associated Heart Failure Using Artificial Intelligence
Pacemakers are an effective treatment for slow heart rates which improve symptoms and save lives. However, for some people pacemakers can cause heart failure (HF) because of the unnatural way in which they stimulate heart beats.
- Trial name
- OPT-AI (NCT07372651)
- Where
- United Kingdom
- Volunteers
- 150 people
- Sponsor
- University of Leeds
Atrial Fibrillation, Bradycardia
Prospective Registry of Pacemaker Patients Concerning Percentage of Right Ventricular Pacing, LVEF and NYHA Class
This registry is a data collection on patients who are implanted for more than 6 months with a pacemaker. Frequency and distribution of right ventricular pacing, NYHA class and left ventricular ejection fraction shall be…
- Conditions
- Atrial Fibrillation, Bradycardia, Heart Block, Sick Sinus Syndrome
- Trial name
- NCT00292539
- Testing
- Any pacemaker with right ventricular pacing option
- Where
- Germany
- Volunteers
- 600 people
- Sponsor
- Guidant Corporation
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
BIO|MASTER.CSP Study
The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP).
- Conditions
- Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial, Cardiac Resynchronization Therapy Devices, Bradycardia
- Trial name
- NCT06620237
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 14 sites in Australia, Belgium and 3 more
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure, Hypertension
Necklace-Shaped Sensor for Non-Invasive Remote Monitoring of Vitals
This study is designed to validate the use of the CoVa Monitoring System in subjects with implanted devices.
- Trial name
- NCT02337790
- Where
- United States
- Volunteers
- 109 people
- Sponsor
- Baxter Healthcare Corporation
Diastolic Heart Failure
Cardiac Resynchronisation Therapy Versus Rate-responsive Pacing in Heart Failure With Preserved Ejection Fraction
Half of patients with heart failure have normal heart pumping function (Heart failure with Preserved Ejection Fraction, HFpEF), most commonly characterised by breathlessness on exercise.
- Trial name
- PREFECTUS (NCT03338374)
- Testing
- Biventricular pacemaker
- Where
- 2 sites in United Kingdom
- Volunteers
- 10 people
- Sponsor
- Cardiff and Vale University Health Board
Heart Failure With Preserved Ejection Fraction, Atrial Dyssynchrony Syndrome
LEft Atrial Pacing in Diastolic Heart Failure
The purpose of this study is to assess left atrial pacing therapy in patients with atrial dyssynchrony syndrome and heart failure with preserved ejection fraction.
- Conditions
- Heart Failure With Preserved Ejection Fraction, Atrial Dyssynchrony Syndrome, Left Atrio-ventricular Asynchrony
- Trial name
- LEAD (NCT01618981)
- Testing
- pace make active/inactive cross over
- Where
- France
- Sponsor
- Centre Hospitalier Universitaire Dijon
Atrioventricular Block, Heart Diseases
Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- BLOCK HF (NCT00267098)
- Testing
- Cardiac Resynchronization Therapy (CRT)
- Where
- 54 sites in United States, Canada
- Volunteers
- 918 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Ventricular Arrhythmias and Cardiac Arrest
Effects of Upgrading From Right Ventricular Pacing to Cardiac Resynchronization Therapy and Comparison With Dual-Chamber Defibrillator
Patients who consecutively underwent de novo CRT implantation, CRT upgrade, and DDDR ICD implantation at the Cardiology Clinic of Bursa Postgraduate Hospital between January 2019 and December 2023 according to the European…
- Trial name
- NCT07077928
- Testing
- Pacemaker upgrade
- Where
- Turkey (Türkiye)
- Volunteers
- 307 people
- Sponsor
- Bursa Postgraduate Hospital