Clinical trials: Pacing
Sinus-node Dysfunction
Right Ventricular Outflow Tract Study
This is a prospective, randomized, double blinded, multi-center, controlled study to evaluate the clinical impact at 18 months after DDD implantation of alternative pacing site (RVOTs and RVA) and the different conduction path…
- Trial name
- RVOTCARE (NCT01294839)
- Testing
- Right ventricular lead location
- Where
- China
- Volunteers
- 380 people
- Sponsor
- Abbott Medical Devices
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
Heart Failure
The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy With MultiPoint Pacing
The purpose of this study is to evaluate the application of Negative AV Hysteresis (NAVH) to improve electrical synchrony in MultiPoint Pacing (MPP) Cardiac Resynchronization Therapy (CRT) patients.
- Trial name
- NCT02782598
- Testing
- CRT+NAVH
- Where
- Italy
- Volunteers
- 17 people
- Sponsor
- Abbott Medical Devices
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
Bradycardia, Left Bundle Branch Area Pacing
Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution
To evaluate the capability to monitor LBB success criteria with the use of a Smart ECG system (ECG monitor, 12 leads ECG cable, ECG viewer software ) during a cardiac device implantation involving the placement of a pacing lead…
- Conditions
- Bradycardia, Left Bundle Branch Area Pacing, Cardiac Resynchronisation Therapy (CRT), ECG
- Trial name
- LBBOT (NCT07254013)
- Testing
- LBBAP implant
- Where
- 4 sites in France
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- MicroPort CRM
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
Pacemaker
CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements
The primary objective of this study is to evaluate the efficacy of the automated data collection in the Zephyr device as compared to manual testing results for atrial and ventricular pacing thresholds.
- Trial name
- CONFIRM (NCT00832988)
- Testing
- VentricularAutoCaptureTM & ACapTM Confirm
- Where
- 6 sites in Canada
- Volunteers
- 115 people
- Sponsor
- Abbott Medical Devices
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
Heart Failure
Triple-site Biventricular Stimulation in the Optimization of CRT
Cardiac resynchronization is a recommended therapy for patients with advanced heart failure, under optimized medical treatment with reduced left ventricular ejection fraction and prolonged QRS, nevertheless, still 30% of the…
- Trial name
- TRIUMPH-CRT (NCT02350842)
- Testing
- triple-site biventricular pacing with peri-operative echo guidance, standard biventricular pacing
- Where
- 14 sites in France, Germany and 4 more
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- MicroPort CRM
Cardiac Electrophysiology
Transvenous Lead Removal Post-Market Clinical Study
This prospective, multicenter, post-market clinical study was designed to evaluate the outcomes of lead extraction of cardiovascular implantable electronic devices (CIED) using Cook catheter and lead extraction devices for any…
- Trial name
- NCT03688412
- Testing
- Cook lead extraction devices
- Where
- 9 sites in United States, Germany and 2 more
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Cook Research Incorporated
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
Multi-site Left Ventricular Pacing
Multi-site Left Ventricular (MSLV) Pacing With Quartet 1458Q Lead
The purpose of this clinical investigation is to evaluate the safety and hemodynamic performance of the MSLV Pacing feature in a clinical setting.
- Trial name
- MSLV (NCT01044472)
- Where
- 10 sites in Germany, United Kingdom
- Volunteers
- 61 people
- Sponsor
- Abbott Medical Devices
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.
Tachycardia
INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs
INTRINSIC RV is a two-armed randomized trial that will compare the effects of innovative dual-chamber pacing with AV Search Hysteresis to standard VVI among ICD patients.
- Trial name
- NCT00148967
- Testing
- Implantable Cardioverter Defibrillator
- Volunteers
- 1,535 people
- Sponsor
- Boston Scientific Corporation
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.
Cardiopulmonary Failure, Myocardial Infarction (MI)
COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable
The COR-INSIGHT trial aims to evaluate the effectiveness of Peerbridge COR advanced ambulatory ECG wearables (COR 1.0 and COR 2.0) in accurately and non-invasively detecting cardiovascular and cardiopulmonary conditions using…
- Conditions
- Cardiopulmonary Failure, Myocardial Infarction (MI), Heart Decompensation, Heart Failure
- Trial name
- COR-INSIGHT (NCT06763549)
- Testing
- SUBPROTOCOL A, SUBPROTOCOL B, SUBPROTOCOL C
- Where
- United States
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Sick Sinus Syndrome
Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)
The purpose of this study is to determine the incidence of atrial fibrillation and heart failure in patients with pacemaker therapy with different pacing modes (AAI, DDD, and a novel algorithm to minimize ventricular pacing).
- Trial name
- NCT00161551
- Testing
- Vitatron T70 DR
- Where
- 5 sites in Germany
- Volunteers
- 402 people
- Sponsor
- Medtronic BRC
Cardiac Rhythm Disorder
3T MRI CIED Post-Approval Study
The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure.
- Trial name
- NCT02969395
- Where
- 204 sites in United States, Belgium and 20 more
- Volunteers
- 41 people
- Sponsor
- Medtronic
Atrial Fibrillation
Atrial Fibrillation: Canadian Atrial Fibrillation Evaluation (CAFE) Study -
To evaluate whether atrial fibrillation (AF) therapies in Guidant Pulsar Max II or Insignia Plus DR have an effect on the occurance of AF in patients with no prior history of AF
- Trial name
- CAFE (NCT00848445)
- Testing
- Guidant Pulsar Max II or Insignia Plus DR, Atrial pacing preference turned on or off
- Volunteers
- 270 people
- Sponsor
- Boston Scientific Corporation