Clinical trials: Pacemakers
Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder
Aveir DR i2i Study
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT05252702
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- 78 sites in United States, Austria and 11 more
- Volunteers
- 464 people
- Sponsor
- Abbott Medical Devices
Patients Implanted With a Pacemaker
Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers
Observational study to assess AV block incidence and their evolution according to paroxysmal atrial arrhythmia.
- Trial name
- NATURE (NCT00531037)
- Where
- 129 sites in United States, Belgium and 9 more
- Volunteers
- 1,440 people
- Sponsor
- LivaNova
Tunisian Patients Already Implanted With a TAVI
Tunisian Registry of Trans Catheter Aortic Valve Implantation
Transcatheter aortic valve implantation (TAVI) has emerged as a transformative therapy for patients with severe aortic stenosis, particularly those designated high-risk or inoperable for traditional surgical valve replacement.
- Trial name
- TAVI-TN (NCT06503965)
- Where
- Tunisia
- Volunteers
- 300 people
- Sponsor
- Les Laboratoires des Médicaments Stériles
AV Block, AV Block Complete
Accelerometer Sensing for Micra AV Study
The purpose of the AccelAV Study is to characterize chronic AV synchrony in subjects implanted with MicraTM AV device. This study will be conducted upon market approval of the MicraTM AV Transcatheter Pacing System.
- Conditions
- AV Block, AV Block Complete, 3rd Degree Heart Block, Complete Heart Block
- Trial name
- AccelAV (NCT04245345)
- Testing
- Accelerometer Sensing for Micra AV Study
- Where
- 20 sites in United States, Hong Kong
- Volunteers
- 157 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
Bradycardia
Registry of Sleep Apnea Monitoring and Atrial Fibrillation in Pacemaker Patients (RESPIRE)
The purpose of the study is to evaluate at 12 Months follow-up the association between Atrial Fibrillation (AF) and Sleep Apnea (SA) severity based on data measured and stored in REPLY 200 DR pacemaker.
- Trial name
- NCT01922726
- Where
- Spain
- Volunteers
- 1,257 people
- Sponsor
- MicroPort CRM
Pacemaker Therapy, Cardiac Resynchronization Therapy
BIO|MASTER.Edora Family Study
This study is designed as post market clinical follow-up study with CE-marked products to evaluate the AV Opt and LV VectorOpt features in the respective Edora family pacemakers under clinical conditions.
- Trial name
- NCT03091322
- Testing
- Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8
- Where
- 11 sites in Austria, Germany and 2 more
- Volunteers
- 120 people
- Sponsor
- Biotronik SE & Co. KG
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
Atrial Fibrillation
Efficacy and Safety Study of an Antiarrhythmic Drug to Treat Atrial Fibrillation in Patients With Pacemakers
The purpose of this study is to determine the safety and efficacy of an investigational antiarrhythmic drug (ATI-2042) in the treatment of atrial fibrillation in patients with a dual chamber pacemaker.
- Trial name
- NCT00389792
- Testing
- ATI-2042, ATI-2042 200 mg
- Where
- 40 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- ARYx Therapeutics
Bradyarrhythmia
Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086
Pacing leads are key elements of a pacing system as their proper functioning is one of the major factors affecting the long term performance of the whole system.
- Trial name
- NCT01522755
- Testing
- Pacing system implant with the CapsureFix MRI pacing lead model 5086
- Where
- France
- Volunteers
- 409 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
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
Hypertension, Atrial Fibrillation
Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial
In patients with a standard indication for pacing and no previous history of AF, detection of Atrial High Rate Episodes predicts an increased risk of stroke and systemic embolism.
- Trial name
- NCT00256152
- Testing
- AF Suppression Pacing Algorithm
- Where
- Canada
- Volunteers
- 2,580 people
- Sponsor
- Abbott Medical Devices
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
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