Clinical trials: Pacemakers
Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted
Registry Study of Clinical Application of MRI Compatible CIED
The purpose of this study is to clear the Safety and Necessity of the Magnetic Resonance Imaging (MRI) in the Presence of CIEDs(Cardiovascular Implantable Electronic Devices).
- Trial name
- NCT02380300
- Volunteers
- 2,067 people
- Sponsor
- Biotronik (Beijing) Medical Device Ltd.
Atrial Fibrillation
Pacemaker Holter Assessment of the Effect of BMS-914392 on Atrial Fibrillation Burden
The purpose of the study is to determine whether treatment with BMS-914392 is safe, well tolerated and associated with a reduction of atrial fibrillation burden in patients with paroxysmal atrial fibrillation and permanent…
- Trial name
- NCT01356914
- Testing
- BMS-914392
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Bristol-Myers Squibb
Atrial Fibrillation, Tachycardia, Supraventricular
Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
The purpose of this study is to find out if specialized programs in the AT500 and EnRhythm pacemakers will reduce the number of irregular heartbeat in the upper chamber of the heart and reduce symptoms (such as shortness of…
- Conditions
- Atrial Fibrillation, Tachycardia, Supraventricular, Arrhythmia, Bradycardia
- Trial name
- NCT00289289
- Testing
- Intervention Pacing Features
- Where
- 38 sites in United States, Canada
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Pacemaker, Arrythmia
AVEIR DR 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 dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05932602
- Testing
- Aveir DR Leadless Pacemaker System, Dual Chamber Transvenous Pacemaker
- Where
- United States
- Volunteers
- 2,812 people
- Sponsor
- Abbott Medical Devices
Heart Failure
One Day Implantation Program for Heart Failure Patients Implanted With CRT-P
This study has been implemented to evaluate cardiac resynchronization therapy pacemaker (CRT-P) implantations on a same-day basis
- Trial name
- OEDIPE-CRT-P (NCT05142293)
- Testing
- Ambulatory procedure
- Where
- 19 sites in France
- Volunteers
- 354 people
- Sponsor
- Biotronik SE & Co. KG
Bradycardia
Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System
The purpose of this study is to report the stability of atrial and ventricular leads by absence of effect of the MRI exam on the pacing and sensing threshold and to report the safety based on the serious adverse events.
- Trial name
- IKONE (NCT02175797)
- Testing
- MRI
- Where
- France
- Volunteers
- 33 people
- Sponsor
- MicroPort CRM
Stroke, Wound Heal
Study of gekoTM Interaction With Cardiac Pacemakers
The gekoTM device is a small disposable battery powered device that attaches to the lower leg near the knee and stimulates the common peroneal nerve, causing muscle contraction of the lower leg.
- Conditions
- Stroke, Wound Heal, Edema Leg, Cardiac Pacemaker Electrical Interference
- Trial name
- NCT04391257
- Testing
- geko™
- Where
- 2 sites in United Kingdom
- Volunteers
- 28 people
- Sponsor
- Firstkind Ltd
Bradycardia, Remote Monitoring
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
The purpose of the clinical investigation is to document the safety and the performances of the remote monitoring functions of the ALIZEA, BOREA and CELEA pacemakers, i.e. the RAAT, the RVAT and the remote alerts.
- Trial name
- CALLIOPE (NCT05165095)
- Testing
- Pacemaker implantation
- Where
- 19 sites in Austria, Belgium and 6 more
- Volunteers
- 206 people
- Sponsor
- MicroPort CRM
Arrhythmia, Bradycardia
MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY
The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices.
- Trial name
- NCT01076374
- Where
- 129 sites in United States, Austria and 10 more
- Volunteers
- 2,927 people
- Sponsor
- Medtronic
Bradycardia
Falls and Cardiovascular Events in Pacemaker Patients
The purpose of this study is to document the number of falls and fractures in Sinus Node Disease (SND) patients.
- Trial name
- NCT01037426
- Testing
- Fill out Questionnaire
- Where
- 8 sites in Switzerland
- Volunteers
- 87 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Pacemaker
CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements
The primary objective of this study is to evaluate the efficacy of the automated data collection in the Zephyr device as compared to manual testing results for atrial and ventricular pacing thresholds.
- Trial name
- CONFIRM (NCT00832988)
- Testing
- VentricularAutoCaptureTM & ACapTM Confirm
- Where
- 6 sites in Canada
- Volunteers
- 115 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Congestive
Home Monitoring in Cardiac Resynchronisation Therapy
In spite of success in the management of heart failure, repetitive rehospitalisation and high mortality rate remain a serious problem.
- Trial name
- HomeCARE (NCT00376116)
- Testing
- Cardiac resynchronisation therapy, Implantable cardioverter-defibrillator
- Where
- 82 sites in Austria, Czechia and 8 more
- Volunteers
- 513 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation
Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers
Primary objective was to evaluate the effects of dronedarone on Atrial Fibrillation (AF) burden (i.e. percent time in AF) as measured on electrogram (EGM) in subjects with a permanent pacemaker.
- Trial name
- HESTIA (NCT01135017)
- Testing
- Dronedarone
- Where
- 92 sites in United States
- Volunteers
- 112 people
- Sponsor
- Sanofi
Bradycardia, Heart Failure
Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
The study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt…
- Trial name
- NCT06018818
- Testing
- Amvia/Solvia pacemaker family
- Where
- 3 sites in Austria, Germany
- Volunteers
- 129 people
- Sponsor
- Biotronik SE & Co. KG
Bradycardia
Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker
The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.
- Trial name
- DREAM (NCT01537718)
- Testing
- REPLY 200
- Where
- 5 sites in France, Spain
- Volunteers
- 40 people
- Sponsor
- LivaNova
Heart Disease, Cardiovascular Disease
Remote Device Interrogation In The Emergency Department
A prospective, post market, non-randomized study to evaluate the reduction in time to interrogation for patients with St. Jude Medical remote care compatible devices interrogated by the unpaired Merlin@home transmitter in the…
- Conditions
- Heart Disease, Cardiovascular Disease, Heart Failure, Arrhythmias, Cardiac
- Trial name
- REMEDY (NCT01871090)
- Testing
- Unpaired remote monitoring transmitter
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Heart Failure
BIO|CONCEPT.Amvia Study
The goal of this exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P)…
- Trial name
- NCT05610176
- Testing
- Amvia Sky pacemaker or CRT-P device
- Where
- 7 sites in Australia, New Zealand
- Volunteers
- 52 people
- Sponsor
- Biotronik Australia Pty Ltd.
Sinus Arrhythmia, Atrial Fibrillation
Electrophysiologically Guided PAcing Site Selection Study
This study is a long-term, prospective, and controlled evaluation of the incidence of persistent atrial fibrillation (AF) in patients with severe intra-right atrial conduction delay paced with preventive algorithms at the…
- Trial name
- EPASS (NCT00239226)
- Testing
- IAS pacing - study group, IAS pacing control group, Pacing RAA study group
- Where
- 8 sites in Italy
- Volunteers
- 102 people
- Sponsor
- Medtronic BRC
Heart Failure, Congestive Heart Failure
PROSPECT: Predictors of Response to Cardiac Re-Synchronization Therapy
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.
- Conditions
- Heart Failure, Congestive Heart Failure, Cardiomyopathy
- Trial name
- NCT00253357
- Where
- 28 sites in United States, Austria and 11 more
- Volunteers
- 450 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Study of the Effects of BMS-919373 on the Electrical Activity of the Heart Using Pacemakers
To determine the effect of our compound (BMS-919373) on electrical activity of the heart using pacemakers.
- Trial name
- NCT02153437
- Testing
- BMS-919373, Sotalol
- Where
- 6 sites in United States, Canada
- Volunteers
- 7 people
- Sponsor
- Bristol-Myers Squibb