Clinical trials: Cardiac Pacing
Sudden Cardiac Death
Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for implantable cardioverter-defibrillator (ICD) therapy and programmed according to current guidance of…
- Trial name
- APPRAISE ATP (NCT02923726)
- Testing
- Arm 1 (ATP+Shock), Arm 2 (shock only)
- Where
- 134 sites in United States, Austria and 6 more
- Volunteers
- 2,692 people
- Sponsor
- Boston Scientific Corporation
Heart Failure
Conduction System Pacing Optimized Therapy
The purpose of the CSPOT study is to determine the best mode of cardiac resynchronization therapy (CRT) pacing for different populations of CRT patients, comparing traditional biventricular or left ventricular pacing (BiV)…
- Trial name
- CSPOT (NCT04905290)
- Testing
- Left ventricular coronary sinus (BiV) configuration, Conduction system pacing-only configuration, Conduction System Pacing Optimized Therapy (CSPOT) configuration
- Where
- 12 sites in United States, Ireland and 2 more
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia
Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication
The purpose of this observational study is the assessment (safety and efficacy) of the St. Jude Medical Tendril MRI™ leads. The Tendril MRI™ leads are a full part of the Accent MRI™ System, consisting of Tendril MRI™ leads and…
- Trial name
- TendrilMRI™ (NCT01528150)
- Volunteers
- 466 people
- Sponsor
- Abbott Medical Devices
AV Block, AV Block Complete
Accelerometer Sensing for Micra AV Study
The purpose of the AccelAV Study is to characterize chronic AV synchrony in subjects implanted with MicraTM AV device. This study will be conducted upon market approval of the MicraTM AV Transcatheter Pacing System.
- Conditions
- AV Block, AV Block Complete, 3rd Degree Heart Block, Complete Heart Block
- Trial name
- AccelAV (NCT04245345)
- Testing
- Accelerometer Sensing for Micra AV Study
- Where
- 20 sites in United States, Hong Kong
- Volunteers
- 157 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia, Congestive Heart Failure
The EASYTRAK EPI Clinical Investigation
The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.
- Trial name
- EASYTRAK EPI (NCT00158925)
- Testing
- EASYTRAK EPI lead
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Heart Failure, Congestive
MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure
The aim of this study is to test the impact of the managed ventricular pacing (MVP) mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed of any death, permanent…
- Trial name
- NCT00262119
- Testing
- Pacemaker Medtronic EnRhythm
- Where
- Italy
- Volunteers
- 1,300 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Permanent Atrial Fibrillation
Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study
The purpose of this study is to monitor heart rate regularization in patients with permanent atrial fibrillation and standard indication for single chamber rate adaptive pacing VVI(R).
- Trial name
- RARE-PEARL (NCT00246805)
- Testing
- Vitatron pacemaker C20 SSIR or T20 SSIR models
- Where
- 13 sites in Italy
- Volunteers
- 67 people
- Sponsor
- Medtronic BRC
Heart Failure
Left Ventricular MultiSpot Pacing for CRT (iSPOT)
The purpose of the iSPOT Study is to evaluate the contractility using positive left ventricular (LV) dP/dt max across LV pacing site(s) in patients indicated for cardiac resynchronization therapy (CRT).
- Trial name
- iSPOT (NCT01883141)
- Testing
- Electrophysiological Study
- Where
- 8 sites in Belgium, Israel and 2 more
- Volunteers
- 31 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia
INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRI
The INFINITE MRI Study is a prospective, non-randomized, multicenter, single arm study aimed at collecting data on ImageReady™ MR Conditional Pacing System (consisting of an INGENIO™ MRI or ADVANTIO™ MRI pacemaker with FINELINE™…
- Trial name
- INFINITE-MRI (NCT01890512)
- Where
- 2 sites in Netherlands
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
Optimize RV Selective Site Pacing Clinical Trial
The purpose of the Optimize RV study is to determine the long-term effect of selective site pacing. Selective site pacing refers to which area of the right ventricle the lead is placed.
- Trial name
- NCT00422669
- Testing
- Medtronic Dual-Chamber Pacemaker, Medtronic SelectSecure 3830 Lead
- Where
- 22 sites in United States, Canada and 4 more
- Volunteers
- 205 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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.
Atrial Fibrillation, Congestive Heart Failure
Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace
The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing…
- Trial name
- AVAIL (NCT00356057)
- Testing
- Protos DR/CLS and Stratos LV CRT pacemakers
- Where
- 10 sites in United States
- Volunteers
- 153 people
- Sponsor
- Biotronik, Inc.
Heart Failure
QP ExCELs: MultiPole Pacing (MPP) Sub-Study
The objective of this MultiPole Pacing (MPP) sub-study of the QP ExCELs study is to demonstrate that the MPP feature is effective by converting a percentage of cardiac resynchronization therapy (CRT) non-responders to responders.
- Trial name
- NCT03155724
- Testing
- MultiPole Pacing
- Where
- 44 sites in United States
- Volunteers
- 53 people
- Sponsor
- Biotronik, Inc.
Heart Failure
PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy
This study will look at different pacing modes (how a device is programmed to pace one's heart), and how these modes may assist in one's daily activities and how one is feeling.
- Trial name
- PEGASUS CRT (NCT00146848)
- Testing
- Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices
- Where
- United States
- Volunteers
- 1,742 people
- Sponsor
- Boston Scientific Corporation
Bradycardia, Sinus Node Dysfunction
LBBAP Data Collection Registry
The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT05887323
- Testing
- Implantation of the Tendril 2088 lead in the LBBA
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 221 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
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
Bradycardia
Reduction of Right Ventricular Pacing Using the Feature Ventricular Intrinsic Preference (VIP)
The purpose of this study is to evaluate the efficacy of the VIP™ feature (available in dual chamber Victory® devices) to reduce unnecessary RV pacing, and to determine if patients with implanted SJM pacemakers will benefit by…
- Trial name
- NCT00311168
- Testing
- Intervention/treatment
- Where
- United States
- Volunteers
- 135 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
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