Clinical trials: Pacemakers
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
Atrial Fibrillation, Arrythmia
Arrythmia Burden in Cardiac Contractility Modulation (CCM)
The Impulse Dynamics Optimizer Device is a Food and Drug Administration (FDA) approved; commercially available device indicated for patients with heart failure with reduced ejection fraction (HFrEF).
- Trial name
- ABC (NCT05704426)
- Testing
- Impulse Dynamics Optimizer Device
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Hackensack Meridian Health
MRI Scans, Magnetic Resonance Imaging
Registry of Patients for MRI With Non-MRI Conditional Pacemakers and ICD Non-MRI Conditional Pacemakers and ICD
The purpose of the registry is to accumulate pre-and post-scan device interrogation data for the purpose of determining the risk of MRI for patients with implantable devices.
- Conditions
- MRI Scans, Magnetic Resonance Imaging, Pacemaker, Implantable Cardioverter Defibrillator
- Trial name
- NCT02318550
- Testing
- MRI Scan
- Where
- United States
- Volunteers
- 262 people
- Sponsor
- Lancaster General Hospital
Wound, Cardiac Arrhythmia
ZIPS Study - Zip Incision aPproximation vs. Suture
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair.
- Trial name
- ZIPS (NCT02213510)
- Testing
- Zip Surgical Skin Closure Device, Standard Suture Closure
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of California, San Diego
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
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
Persistent Atrial Fibrillation, Cardiac Arrhythmia
Investigation of Therapeutic Ablation Versus Cardioversion for AF
The main aim of the research is to investigate whether patients undergoing pulmonary vein isolation with cryoablation for atrial fibrillation (AF) will have lower rates of AF recurrence than those treated by DC cardioversion…
- Trial name
- ORBITA-AF (NCT03907982)
- Testing
- DC Cardioversion, Pulmonary vein isolation, Implantable loop recorder
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Barts & The London NHS Trust
Heart Failure, Congestive
Effect of Chronic Changes in Heart Rate on Congestive Heart Failure
This will be a double blind randomized crossover study of patients with congestive heart failure and a heart rate dependent upon a permanent pacemaker.
- Trial name
- NCT00389649
- Testing
- heart rate setting
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- University of Maryland, Baltimore
Bradycardia
Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
This is a randomized, prospective, single-blinded, multi-center study involving approximately 1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness of Closed Loop Stimulation (CLS) rate…
- Trial name
- CLEAR (NCT00355797)
- Testing
- Closed Loop Stimulation (CLS), Standard Rate Adaptive (R) Technology, Non-rate adaptive (DDD) pacing
- Where
- 99 sites in United States
- Volunteers
- 1,491 people
- Sponsor
- Biotronik, Inc.
Atrial Fibrillation, Heart Failure
AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study
The purpose of this study is to determine whether early atrioventricular node (AVN) ablation with pacing device therapy will reduce death and hospitalization when compared to the conventional drug therapy in elderly patients with…
- Trial name
- PACIFIC (NCT00589303)
- Testing
- FDA approved rate and rhythm control drugs, AV Node ablation and device implant
- Where
- 6 sites in United States, Canada
- Volunteers
- 27 people
- Sponsor
- Mayo Clinic
Safety of the ProMRI Pacemaker System Under Specific MRI Conditions
ProMRI Study of the Entovis Pacemaker System
The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions.
- Trial name
- NCT01761162
- Testing
- Patients with a ProMRI Pacemaker System, Magnetic Resonance Imaging (MRI) scan
- Where
- 25 sites in United States
- Volunteers
- 229 people
- Sponsor
- Biotronik, Inc.
Heart Failure, Atrial Fibrillation
Rhythm Control - Catheter Ablation With or Without Anti-arrhythmic Drug Control of Maintaining Sinus Rhythm Versus Rate Control With Medical Therapy and/or Atrio-ventricular Junction Ablation and Pacemaker Treatment for Atrial Fibrillation
Atrial fibrillation and heart failure are two common heart conditions that are associated with an increase in death and suffering. When both of these two conditions occur in a patient the patient's prognosis is poor.
- Trial name
- RAFT-AF (NCT01420393)
- Testing
- Rhythm control, Rate Control
- Where
- 21 sites in Brazil, Canada and 2 more
- Volunteers
- 411 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Cardiovascular Disease
Comparison of Cyanoacrylate Tissue Adhesive and Suture for Closure of Cardiac Device Pockets
The purpose of this study is to determine whether cyanoacrylate tissue adhesive is as effective as polyglactin 910 suture for surgical closure of cardiac device pockets.
- Trial name
- NCT00674128
- Testing
- Cyanoacrylate tissue adhesive (Dermabond), Polyglactin 910 suture (Vicryl)
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- Mayo Clinic
Post-operative Pain
A Trial Assessing The Association Between Type Of Local Anesthesia Treatment And Postoperative Pain In Patients In Having Undergone Arrhythmia Surgery
The goal of the proposed study is to investigate the relationship between two standard treatments, lidocaine or a mixture of lidocaine and bupivacaine, and 1) postoperative pain, and; 2) narcotic use following pacemaker or…
- Trial name
- NCT01300377
- Testing
- Bupivacaine / Lidocaine, Lidocaine
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Baylor Research Institute
Indications for VVI(R) Pacemaker
The LEADLESS Observational Study
The objective of the study is to confirm clinical performance and safety of the Nanostim leadless cardiac pacemaker system within its intended use and according to its instructions for use.
- Trial name
- NCT02051972
- Testing
- Implanted with a Nanostim leadless pacemaker system
- Where
- 32 sites in Czechia, France and 5 more
- Volunteers
- 491 people
- Sponsor
- Abbott Medical Devices
Bradycardia
A Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing
The COMPARE-Adapta study is a randomized, multi-center, prospective study conducted in China. The purpose of the study is to compare the ability of Search AV™+ and Managed Ventricular Pacing® (MVP®) to reduce ventricular pacing…
- Trial name
- COMPARE (NCT01039467)
- Testing
- Medtronic Adapta Dual Chamber Pacemaker
- Where
- 30 sites in China
- Volunteers
- 385 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradyarrhythmia
Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function
The technological progress allowed the development of more and more sophisticated pacemakers, widening the therapeutic indications but also meeting the physiological needs of the patient.
- Trial name
- NCT01513538
- Testing
- TherapyGuide
- Where
- France
- Volunteers
- 700 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiomyopathy, Cardiac Arrhythmia
RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators
If a surgical sponge is mistakenly left inside a patient's body after a surgical procedure, it can cause a serious infection. To prevent this from happening, a new device has been developed that uses radiofrequency (RF) signals…
- Conditions
- Cardiomyopathy, Cardiac Arrhythmia, Heart Failure, Chronic Thromboembolic Pulmonary Hypertension
- Trial name
- RF (NCT02111980)
- Testing
- RF Assure Scanning
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Diego