Clinical trials: Cardiac Pacing
Arrhythmias, Cardiac
SIELLO Pilot Study for Comparison of Steroid Versus Non-Steroid Pacing Leads
This investigation is designed to demonstrate the clinical efficacy and safety of the low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical investigation.
- Trial name
- NCT01000532
- Testing
- SIELLO JT/T, Pacemaker therapy, BPPU JT/T
- Where
- Hungary
- Volunteers
- 88 people
- Sponsor
- Biotronik SE & Co. KG
Bradycardia, Atrioventricular Block
BIOTRONIK Conduction System Pacing With the Solia Lead
The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia S pacing lead when implanted in the left bundle branch (LBB) area.
- Conditions
- Bradycardia, Atrioventricular Block, Left Bundle-Branch Block, Cardiomyopathies
- Trial name
- BIO-CONDUCT (NCT05251363)
- Testing
- Solia S lead
- Where
- 14 sites in United States
- Volunteers
- 194 people
- Sponsor
- Biotronik, Inc.
Heart Failure
PACMAN - PAcing for CardioMyopathies, a EuropeAN Study
The purpose of this study was to evaluate the benefit of biventricular pacing in patients with heart failure who were receiving optimal pharmacological therapy, and who were either with or without an ICD indication
- Trial name
- NCT00180596
- Testing
- Contak heart failure devices
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 262 people
- Sponsor
- Boston Scientific Corporation
Conduction Defect
Subcostal Temporary Extracardiac Pacing Study
Up to 15 subjects will be enrolled to evaluate initial safety and performance of the AtaCor Temporary Pacing System. Safety will be evaluated through analysis of all Adverse Events.
- Trial name
- STEP (NCT04096365)
- Testing
- Subcostal Temporary Extracardiac Pacing Lead
- Where
- Paraguay
- Volunteers
- 12 people
- Sponsor
- AtaCor Medical, Inc.
Bradycardia
SALT - Success of Active Versus Passive Lead Fixation of Atrial Pacing/Sensing Electrodes
Randomised Comparison with regards to complication rate and electrical measurements of atrial leads with different fixation mechnism
- Trial name
- SALT (NCT00180570)
- Testing
- FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ
- Where
- Sweden
- Volunteers
- 385 people
- Sponsor
- Guidant Corporation
Atrial Fibrillation, Atrial Tachyarrhythmia
LEAF - Low Energy In Atrial Fibrillation
The purpose of the study is to demonstrate the efficiency on AT / AF prevention and termination of a new algorithm contained in the Medtronic AT500 Antitachycardia device in patients with conventional pacemaker indications.
- Trial name
- NCT00157781
- Testing
- Medtronic AT500
- Volunteers
- 237 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Diseases
APPROPRIATE - Rate Adaptive Pacing Sensor
The APPROPRIATE study will compare differences in functional capacity (peak VO2) between chronotropically incompetent patients randomized to receive rate responsive pacing driven by either the minute ventilation…
- Trial name
- APPROPRIATE (NCT00757666)
- Testing
- Rate adaptive pacemaker
- Where
- 2 sites in United States
- Volunteers
- 566 people
- Sponsor
- Boston Scientific Corporation
Arrhythmia, Heart Failure
Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study
The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968 lead. This study is part of the Medtronic System Longevity Study.
- Trial name
- 4968 (NCT01076361)
- Where
- 106 sites in United States, Australia and 12 more
- Volunteers
- 370 people
- Sponsor
- Medtronic
Heart Failure
Evaluation of Left Ventricular Autothreshold, Phase Two
This study will collect data, from an implanted Cardiac Resynchronization Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart failure devices.
- Trial name
- ELEVATE 2 (NCT01242722)
- Testing
- CRT-D
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Left Bundle-Branch Block
Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block
This is a prospective, single-arm, non-randomized, non-blinded study designed to characterize the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony and to characterize morphology and…
- Trial name
- MAP HIS HF (NCT03803995)
- Testing
- Mapping and Pacing the His Bundle, Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Abbott Medical Devices
Tachycardia
Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications
This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and…
- Trial name
- OPTION (NCT00729703)
- Testing
- Ovatio DR 6550
- Where
- 55 sites in United States, Belgium and 7 more
- Volunteers
- 462 people
- Sponsor
- LivaNova
Heart Failure
MultiPoint Pacing Mapping Study
The purpose of this study is to characterize left ventricular acute hemodynamic and electrical responses during cardiac resynchronization therapy (CRT) with different Multipoint Pacing (MPP) settings, and assess the relationship…
- Trial name
- NCT02547207
- Where
- 4 sites in France, Germany and 1 more
- Volunteers
- 7 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Cardiomyopathy
InSync Implantable Cardioverter Defibrillator Registry: Cardiac Resynchronization 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.
- Trial name
- NCT00289302
- Testing
- Cardiac resynchronization therapy device
- Where
- 51 sites in United States
- Volunteers
- 600 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia, Cardiac Resynchronization Therapy
Safety and Performance Evaluation of a New Catheter Range for Lead Implantation at Interventricular Septum
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
- Conditions
- Bradycardia, Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing, Left Bundle Branch Pacing
- Trial name
- POLARIS (NCT06453850)
- Testing
- Use of FLEXIGO delivery catheter
- Where
- 17 sites in France, Germany and 3 more
- Volunteers
- 216 people
- Sponsor
- MicroPort CRM
Acute Myocardial Infarction, Restenoses, Coronary
Abbott Vascular Medical Device Registry
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use…
- Conditions
- Acute Myocardial Infarction, Restenoses, Coronary, Coronary Artery Lesions, Venous Embolism
- Trial name
- AV-MDR (NCT04573660)
- Testing
- Coronary and peripheral stents, Pacing catheters, Vascular plugs
- Where
- 37 sites in United States, Australia and 12 more
- Volunteers
- 3,784 people
- Sponsor
- Abbott Medical Devices
Heart Failure With Preserved Ejection Fraction
Evaluation of Rate Adaptive Pacing on Chronotropic Response in Preserved Ejection Fraction HF
RESPOND-HF is a prospective, multi-center, non-significant risk pilot study with cross-over design. The purpose of the study is to investigate if rate adaptive pacing has the potential to provide benefit to HF patients with…
- Trial name
- RESPOND-HF (NCT03160625)
- Testing
- Rate Adaptive Pacing
- Where
- 5 sites in United States
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachyarrhythmia
APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias
The goal of APART is the assessment of the therapeutic and preventive stimulation algorithms of the Medtronic AT500 and following devices in patients with atrial tachyarrhythmias and an indication for cardiac pacing according to…
- Trial name
- NCT00170274
- Testing
- Activation of preventive and therapeutic algorithms for treatment of AF, AF Prevention and Therapy Algorithms On
- Where
- 6 sites in Germany
- Volunteers
- 156 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Conduction Defect
Subcostal Temporary Extracardiac Pacing II Study
Up to 12 subjects will be enrolled (up to 8 undergoing an AtaCor Temporary Pacing System procedure) in order to evaluate initial safety and performance of the AtaCor Temporary Pacing System when used with three (3) strategies for…
- Trial name
- STEP II (NCT04374929)
- Testing
- StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy, StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid, Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing)
- Where
- 2 sites in New Zealand, Paraguay
- Volunteers
- 7 people
- Sponsor
- AtaCor Medical, Inc.
Bradycardia
Clinical Investigation of the SelectSecure Pacing Lead
People who have a slow heart beat, or whose heart does not beat on its own, may be in need of an electronic device called a pacemaker. A pacemaker is implanted surgically just under the skin in the upper chest area.
- Trial name
- NCT00266682
- Testing
- Pacing Lead
- Where
- 31 sites in United States, Australia and 1 more
- Volunteers
- 365 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure