Clinical trials: Pacemakers, 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
Congestive Heart Failure
Monitoring of Arrhythmias and HRV in Patients With Heart Failure Treated With the CRT Pacemaker Renewal TR2
The objective of this study is to evaluate the prevalence of sustained ventricular and supraventricular rhythm disorders in patients implanted with a CONTAK RENEWAL TR2 ventricular resynchronization therapy (CRT) device
- Trial name
- NCT00180531
- Testing
- Renewal TR2
- Where
- 10 sites in France
- Volunteers
- 500 people
- Sponsor
- Guidant Corporation
Heart Failure
Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation
The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the IMED-4
- Trial name
- NCT02191696
- Testing
- IMED-4 recording
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Intersection Medical, Inc.
Any Patient Who Fulfills the Inclusion Criteria to be Implanted With a Dual Chamber Pacemaker Maybe Included in the Study as Per ACC/AHA Guidelines
Comparison of AAIsafeR and DDD Modes in Non-selected Patients
1 Purpose In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated bradycardia, single chamber atrial pacemakers…
- Trial name
- CAN-SAVE R (NCT01219621)
- Testing
- Symphony Dual Chamber Rate Responsive Device
- Where
- 10 sites in Canada
- Volunteers
- 450 people
- Sponsor
- Sorin Group Canada
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
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
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
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
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
Congestive Heart Failure, Atrial Fibrillation
Study to Characterize Atrial Fibrillation in CHF Patients Indicated for CRT
The purpose of the study is to characterize atrial arrhythmias in patients indicated for Cardiac Resynchronization Therapy (CRT) and to monitor changes in atrial arrhythmias while CRT is provided.
- Trial name
- NCT00156728
- Testing
- Vitatron biventricular pacemaker
- Where
- 23 sites in Czechia, France and 5 more
- Volunteers
- 172 people
- Sponsor
- Medtronic BRC
Atrioventricular Block
Ventricular Pacing Site Selection (V-PASS)
The purpose of this study is to determine whether there is a relationship between ventricular lead position and the incidence of heart failure and atrial fibrillation in patients with indication for permanent pacemaker…
- Trial name
- NCT00292383
- Testing
- Leads to be implanted according randomization on specified sites. Vitatron pacemakers to be implanted: T60 DR, T70 DR, T20 SR, C60 DR
- Where
- 3 sites in Germany
- Volunteers
- 100 people
- Sponsor
- Medtronic BRC