Clinical trials: Pacing
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
Heart Failure, Congestive, Ventricular Fibrillation
Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation
The purpose of this study was to determine if cardiac resynchronization therapy when combined with defibrillation is safe and effective in the treatment of symptomatic heart failure.
- Conditions
- Heart Failure, Congestive, Ventricular Fibrillation, Tachycardia, Ventricular
- Trial name
- NCT00387803
- Testing
- Cardiac Resynchronization Therapy with Defibrillation
- Where
- United States
- Volunteers
- 581 people
- Sponsor
- Boston Scientific Corporation
Sudden Cardiac Death
Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
The aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.
- Trial name
- Prediction (NCT00560768)
- Testing
- Ovatio VR 6250 or DR6550
- Where
- 30 sites in United States, Canada and 2 more
- Volunteers
- 198 people
- Sponsor
- LivaNova
Bradycardia
Micra Transcatheter Pacing System Post-Approval Registry
Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial…
- Trial name
- NCT02536118
- Testing
- Micra Transcatheter Pacing System
- Where
- 156 sites in United States, Belgium and 22 more
- Volunteers
- 3,100 people
- Sponsor
- Medtronic
Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients.
Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication
The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients.
- Trial name
- ANSWER (NCT00562107)
- Testing
- Symphony DR 2550 and REPLY DR cardiac pacemakers
- Where
- 37 sites in United States, France and 4 more
- Volunteers
- 650 people
- Sponsor
- LivaNova
Pacemaker, Bradycardia
Adapta Pacing System Clinical Study
Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow).
- Trial name
- NCT00307073
- Testing
- Implantable Pulse Generator
- Where
- 7 sites in Austria, Czechia and 4 more
- Volunteers
- 120 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachyarrhythmia
Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
The LEADR study is designed to assess the safety and efficacy of the Next Generation ICD lead. The LEADR LBBAP study is being conducted under the existing US FDA Investigational Device Exemption (IDE) for the Next Generation ICD…
- Trial name
- NCT04863664
- Testing
- Defibrillation (RV Implant), Defibrillation (LBBAP Implant)
- Where
- 55 sites in United States, Australia and 18 more
- Volunteers
- 998 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Magnetic Resonance Imaging (MRI), Cardiac Pacing
Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment
The purpose of this study is to test the safety and effectiveness of the Medtronic CapSureFix Novus Model 5076 lead when patients are implanted with the Medtronic Advisa MRI pacemaker and undergo an MRI scan.
- Trial name
- NCT01755143
- Testing
- Magnetic Resonance Imaging scan sequences of the head, neck, and chest, Pacemaker System
- Where
- 36 sites in Australia, Austria and 17 more
- Volunteers
- 266 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Personalized CRT - MPP Post Approval Study
The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release.
- Trial name
- NCT03232944
- Testing
- Cardiac Resynchronization Therapy - MPP
- Where
- 78 sites in United States, Belgium and 11 more
- Volunteers
- 1,338 people
- Sponsor
- Medtronic
Ventricular Tachycardia
Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)
Medtronic is sponsoring the Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS) to further confirm safety and effectiveness of ventricular iATP therapy in routine clinical practice, following commercial release of…
- Trial name
- NCT04496518
- Testing
- Intrinsic Antitachycardia Pacing (iATP) Therapy
- Where
- 92 sites in United States, France and 7 more
- Volunteers
- 2,200 people, healthy volunteers welcome
- Sponsor
- Medtronic
Concussion, Brain
EEG-guided Cognitive Pacing Tool During Concussion Recovery
This investigation will assess the utility of a novel wearable electroencephalography (EEG) headband linked to a mobile application to monitor cognitive activity post-concussion, and alert a patient when it is time to take a…
- Trial name
- NCT05522855
- Testing
- EEG Sensorband and mobile application
- Volunteers
- 50 people
- Sponsor
- Dr. Matthew Kennedy
Bradycardia, Slow Heart Beat
EMRI SureScan™ Clinical Study
The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan…
- Trial name
- NCT00433654
- Testing
- Implantable Pulse Generator (IPG) and Pacing Leads (wires), Magnetic Resonance Imaging (MRI) scan
- Where
- 45 sites in United States, Austria and 9 more
- Volunteers
- 484 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Bradycardia
Micra AV Transcatheter Pacing System Post-Approval Registry
Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care…
- Trial name
- Micra AV PAS (NCT04253184)
- Testing
- Micra AV Transcatheter Pacing System
- Where
- 89 sites in United States, Belgium and 18 more
- Volunteers
- 802 people
- Sponsor
- Medtronic
Heart Failure
Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (The CORE-CPP Study)
The purpose of this study is to use real-world evidence to validate that conduction system pacing (CSP), delivered via a Medtronic 3830 catheter-delivered lead and a Medtronic dual-chamber transvenous pacemaker, is a safe and…
- Trial name
- CORE-CPP (NCT06606288)
- Testing
- Conduction system pacing, Bi-ventricular pacing
- Where
- United States
- Volunteers
- 6,000 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Chronic Obstructive Airway Disease
Clinical Study to Investigate Safety and Performance of NeuRx DPS in Patients Undergoing Bilateral Lung Transplantation
This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from…
- Trial name
- NCT02411383
- Testing
- NeuRx Diaphragm Pacing System
- Where
- Belgium
- Volunteers
- 4 people
- Sponsor
- Synapse Biomedical
Arrhythmia, Bradycardia
CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse
This study compares the pacemaker's automatic pacing threshold measurements to the manual measurements conducted by a health care provider.
- Trial name
- NCT00275769
- Testing
- Pacemaker
- Where
- 57 sites in United States, Canada
- Volunteers
- 860 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Model 4296 Left Ventricular (LV) Lead Study
This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms.
- Trial name
- 4296 (NCT00927251)
- Testing
- Pacing Lead (Model 4296 LV Lead)
- Where
- 16 sites in Austria, Finland and 6 more
- Volunteers
- 90 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