Clinical trials: Pacing
Heart Failure
Quartet Lead and Resynchronization Therapy Options III (QUARTO_III)
The purpose of the study is to assess prospectively at 6 months the percentage of responder patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet Left Ventricular (LV) quadripolar lead and with…
- Trial name
- QUARTO_III (NCT02476201)
- Testing
- MPP ON
- Where
- Spain
- Volunteers
- 105 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
Osteoarthritis, Pain
Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis
The primary objective of this project is to examine effectiveness of a tailored pacing intervention on fatigue, pain, and physical function compared to general pacing intervention and usual care groups.
- Trial name
- AIM (NCT01192516)
- Testing
- Tailored Activity Pacing, General Activity Pacing
- Where
- United States
- Volunteers
- 195 people
- Sponsor
- US Department of Veterans Affairs
Sudden Cardiac Arrest, Ventricular Arrythmia
Improve Sudden Cardiac Arrest Study
The purpose of this study is to demonstrate that primary prevention patients with one or more additional risk factors (1.5 prevention criteria: syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent…
- Trial name
- NCT02099721
- Testing
- ICD or CRT-D Device
- Where
- 93 sites in Argentina, Belarus and 14 more
- Volunteers
- 4,222 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
Cardiomyopathy, Cardiac Arrhythmia
RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators
If a surgical sponge is mistakenly left inside a patient's body after a surgical procedure, it can cause a serious infection. To prevent this from happening, a new device has been developed that uses radiofrequency (RF) signals…
- Conditions
- Cardiomyopathy, Cardiac Arrhythmia, Heart Failure, Chronic Thromboembolic Pulmonary Hypertension
- Trial name
- RF (NCT02111980)
- Testing
- RF Assure Scanning
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Diego
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
Ventricular Tachycardia, Ventricular Fibrillation
The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock
The RAPTURE Study will determine whether dual chamber defibrillators with atrial prevention and termination therapies, minimized ventricular pacing, and remote monitoring will reduce the rate of inappropriate shocks and improve…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Atrial Fibrillation, Supraventricular Tachycardia
- Trial name
- RAPTURE (NCT00787800)
- Testing
- Dual Chamber ICD, Single Chamber ICD
- Where
- 4 sites in United States, Israel
- Volunteers
- 100 people
- Sponsor
- Mayo Clinic
Heart Failure
Model 4396 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 and effective.
- Trial name
- 4396 (NCT00853593)
- Testing
- Pacing Lead
- Where
- 31 sites in United States, Australia and 6 more
- Volunteers
- 197 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia
Micra Transcatheter Pacing System Continued Access Study Protocol
Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to the Micra System while the marketing application is under review by the Food and Drug Administration (FDA).
- Trial name
- NCT02488681
- Testing
- Micra Pacemaker Implant
- Where
- 29 sites in United States
- Volunteers
- 285 people
- Sponsor
- Medtronic
Heart Failure
Quadripolar CRT-D On Currently Approved Lead SystemS
The purpose of the study is to evaluate different ways to program around extracardiac stimulation.
- Trial name
- CROSS X4 (NCT02232984)
- Where
- 60 sites in United States
- Volunteers
- 749 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Wide QRS Complex
Predictors of Response to Biventricular Pacing in Heart Failure
Heart Failure (HF) is a disease of epidemic proportion in the U.S. affecting over 5 million individuals. It is estimated that in the next year nearly 400,000 new cases will be diagnosed, 1 million individuals will be hospitalized…
- Trial name
- NCT00156390
- Testing
- echo-guided left ventricular lead placement, LV lead placement as per standard of care (without echo guidance)
- Where
- United States
- Volunteers
- 187 people
- Sponsor
- Samir Saba
Heart Failure
Attain Stability™ Quad Clinical Study
The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quadripolar MRI SureScan Left Ventricular (LV) lead (Model 4798).
- Trial name
- NCT03099655
- Testing
- Attain Stability Quad Left Ventricular Pacing Lead
- Where
- 50 sites in United States, Canada and 8 more
- Volunteers
- 471 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
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
Congestive Heart Failure
His Bundle Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy
The goal of this study is to compare the effectiveness of pacing from a physiologic His bundle (HB) lead position versus with the standard coronary sinus (CS) lead position in subjects with heart failure undergoing cardiac…
- Trial name
- His-SYNC (NCT02700425)
- Testing
- CRT Pacemaker
- Where
- 8 sites in United States
- Volunteers
- 41 people
- Sponsor
- University of Chicago
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
Cardiac Pacing, Right Ventricular Pacing
Optimize RV Follow-up Selective Site Pacing Clinical Trial
The purpose of the Optimize RV Follow-Up 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.
- Conditions
- Cardiac Pacing, Right Ventricular Pacing, Left Ventricular Ejection Fraction
- Trial name
- ORVFUP (NCT00949715)
- Testing
- Medtronic or Vitatron Dual-Chamber Pacemaker, Medtronic SelectSecure 3830 Lead
- Where
- 12 sites in United States, Israel and 1 more
- Volunteers
- 67 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Congenital Heart Disease, Bradycardia Sinus
Specialized Pacing for Patients With Congenital Heart Disease
The closed-loop stimulation (CLS) algorithm is a novel sensor-based technology that relies on the change in myocardial systolic impedance for modulation of the heart rate during physical and emotional stress.3 The pacing…
- Trial name
- NCT03361189
- Testing
- Closed loop stimulation, Standard rate response
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of California, Los Angeles
Heart Failure
Intra-procedural Transthoracic EChocardiogram to Facilitate Left Bundle Branch Area Pacing (LBBAP)
The goal of this observational study is to learn more about whether or not the use of heart ultrasound during pacemaker implantation is helpful. The main questions this aims to answer are: 1.
- Trial name
- EC-LBBAP (NCT05646251)
- Testing
- Heart Ultrasound
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Geisinger Clinic