Clinical trials: Cardiac Pacing
Cardiac Pacing, Artificial
Closed Loop Stimulation, Cognitive Performance, and Quality of Life in Pacemaker Patients
The purpose of this study is to compare the influence of accelerometer-based rate adaptation and Closed Loop Stimulation on cognitive performance and quality of life in pacemaker patients.
- Trial name
- COGNITION (NCT00323661)
- Testing
- Rate-adaptive pacemaker: accelerometer, Rate-adaptive pacemaker: Closed Loop Stimulation
- Where
- 55 sites in Australia, Austria and 8 more
- Volunteers
- 405 people
- Sponsor
- Biotronik SE & Co. KG
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
Bradycardia
ENHANCE-Efficacy of the Presence of Right Ventricular Apical Pacing Induced Ventricular Dyssynchrony as a Guiding Parameter for Biventricular Pacing in Patients With Bradycardia and Normal Ejection Fraction
The purpose of this clinical project is to evaluate the efficacy of the presence of Right Ventricular Apical (RVA) pacing induced ventricular dyssynchrony as a guiding parameter for bi-ventricular pacing in patients with…
- Trial name
- ENHANCE (NCT01559311)
- Testing
- CRT-P OFF, CRT-P ON, DDDR
- Where
- 7 sites in Australia, China and 3 more
- Volunteers
- 98 people
- Sponsor
- Abbott Medical Devices
Tachycardia, Ventricular, Ventricular Fibrillation
ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast…
- Trial name
- ADVANCE_D (NCT00147277)
- Testing
- Implantable Cardiac Defibrillator
- Where
- Italy
- Volunteers
- 925 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia, Sick Sinus Syndrome
Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
This study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of the three following indications: sinus…
- Conditions
- Bradycardia, Sick Sinus Syndrome, Heart Block
- Trial name
- NCT00286858
- Testing
- Insignia Ultra and Insignia AVT
- Where
- 40 sites in France, Guadeloupe
- Volunteers
- 903 people
- Sponsor
- Boston Scientific Corporation
Cardiac Pacing, Electric Countershock
Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)
Patients with implantable cardioverter defibrillators (ICDs) should undergo regular device follow-ups every 3 months, to verify proper ICD function.
- Conditions
- Cardiac Pacing, Electric Countershock, Ventricular Tachyarrhythmia
- Trial name
- ANVITE (NCT00858559)
- Testing
- Implantable cardioverter defibrillator with Home Monitoring function, Standard implantable cardioverter defibrillator
- Where
- Germany
- Volunteers
- 110 people
- Sponsor
- Biotronik SE & Co. KG
Ventricular Tachycardia (VT), Ventricular Fibrillation
Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D
The goal of this observational study is to investigate the changes of LBB EGM during daily activities and overdrive pacing at the time of peri-implantation and up to 6-month follow-ups of ICD/CRT-D patients.
- Trial name
- NCT06745778
- Where
- 2 sites in China
- Volunteers
- 50 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia
China Micra Transcatheter Pacing Study
The China Micra Transcatheter Pacing Study is a prospective, multi-center, single arm human clinical trial utilizing Objective Performance Criterion (OPC) to confirm the safety and efficacy profile of the Micra system for…
- Trial name
- NCT03624504
- Testing
- Micra Transcatheter Pacing System (TPS)
- Where
- 7 sites in China
- Volunteers
- 82 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Disease
Managed Ventricular Pacing ("MVP") Trial
The purpose of the study is to compare two device settings (sets of instructions) used by the ICD. The Implantable Cardiac Defibrillator ("ICD") can be set to use one wire (top or bottom of the heart) or two wires (top and…
- Trial name
- MVP (NCT00281099)
- Testing
- ICD (Implantable Cardioverter Defibrillator)
- Where
- 73 sites in United States, Austria and 10 more
- Volunteers
- 1,031 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Sick Sinus Syndrome
Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study
The objective of this study is to intra-individually compare the performances of two pacemaker algorithms designed to reduce unnecessary right ventricular pacing: Intrinsic Rhythm Support Plus (IRSplus) and Ventricular Pace…
- Trial name
- VIPERS (NCT01528657)
- Testing
- Ventricular Pace Suppression (Vps), Intrinsic rhythm support (IRSplus)
- Where
- 20 sites in Italy
- Volunteers
- 230 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure
Placement of CS/LV Pacing Leads With EnSite NavX Guidance
This study utilizes the 3D mapping capabilities of the EnSite NavX mapping system to help guide the placement of the left ventricular lead during cardiovascular resynchronization therapy implant procedures with the goal of…
- Trial name
- NCT00577187
- Testing
- EnSite NavX-Guided CRT implant
- Where
- United States
- Sponsor
- Abbott Medical Devices
Heart Failure
Multisite Pacing With a Quadripolar Lead
The purpose of this study is to evaluate the effects of multisite left ventricular (LV) biventricular (BiV) pacing on LV hemodynamics in CRT patients.
- Trial name
- NCT00964938
- Testing
- Quadripolar LV lead (pacing configurations)
- Where
- Canada
- Volunteers
- 35 people
- Sponsor
- Abbott Medical Devices
Bradycardia
INGEVITY™ Observational Trial
The objectives of this registry are to 1. Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems involving the INGEVITY lead based on observations / events 2.
- Trial name
- GENTLE (NCT02166606)
- Testing
- ImageReady MR Conditional Pacing System Implant
- Where
- 60 sites in Austria, Belgium and 11 more
- Volunteers
- 1,184 people
- Sponsor
- Boston Scientific Corporation
Heart Failure
MultiPoint Pacing IDE Study
This IDE study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment with standard BiV pacing at 9 months.
- Trial name
- MPP IDE (NCT01786993)
- Testing
- MultiPoint Pacing, Traditional Biventricular Pacing
- Where
- 49 sites in United States
- Volunteers
- 506 people
- Sponsor
- Abbott Medical Devices
Bradyarrhythmia
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications OPTI-MIND 2
The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.
- Trial name
- OPTI-MIND 2 (NCT01715558)
- Where
- 39 sites in Belgium, Denmark and 7 more
- Volunteers
- 514 people
- Sponsor
- Boston Scientific Corporation
Cardiac Pacemaker, Artificial
Imaging Study of Lead Implant for His Bundle Pacing
The purpose of this research study is to assess the implant success proportion of the Medtronic SelectSecure MRI SureScan Model 3830 pacing lead at the bundle of His for His bundle pacing.
- Trial name
- (IMAGE-HBP) (NCT03294317)
- Testing
- His bundle pacing
- Where
- 3 sites in United States
- Volunteers
- 70 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Sick Sinus Syndrome, AV Block
HBP Device EGM Data Collection
This is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent His bundle (HB) pacing lead and an existing Abbott permanent pacemaker, defibrillator, or cardiac…
- Conditions
- Sick Sinus Syndrome, AV Block, Heart Failure
- Trial name
- NCT03564860
- Testing
- Device data collection
- Where
- 3 sites in United States
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
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
Bradyarrhythmia
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
The study objective is to collect mid-term clinical outcome in a group of patients implanted with permanent pacemaker (PM) according to real-life clinical practice in a multicenter and international environment.
- Trial name
- OPTI-MIND (NCT00976482)
- Where
- Germany
- Volunteers
- 1,745 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Cardiomyopathy
InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry
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
- NCT00273182
- Testing
- InSync Model 8040, InSync III Model 8042
- Where
- 82 sites in United States
- Volunteers
- 1,999 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure