Clinical trials: Pacemakers
Bradycardia, Atrial Tachyarrhythmia
Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)
The purpose of this study is to evaluate the effects that electromagnetic field exposure from using a tablet and smart phone have on a leadless pacemaker (MICRA device).
- Trial name
- MICRA (NCT02758210)
- Testing
- Use of a Tablet, Use of a Smart Phone
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Emory University
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
Bradycardia, Tachycardia
Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation
Patients requiring long term anticoagulation often undergo transition of their warfarin to heparin in anticipation of invasive surgical procedures such as pacemaker or ICD implantation.
- Conditions
- Bradycardia, Tachycardia, Atrial Fibrillation, Valvular Heart Disease
- Trial name
- NCT00721136
- Testing
- continue warfarin through the procedure, Hold warfarin, Warfarin held with heparin transition.
- Where
- 2 sites in United States
- Volunteers
- 104 people
- Sponsor
- Johns Hopkins University
Bradycardia
The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker
Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker.
- Trial name
- NCT02030418
- Testing
- Leadless Pacemaker
- Where
- 59 sites in United States, Australia and 1 more
- Volunteers
- 952 people
- Sponsor
- Abbott Medical Devices
Cardiovascular Diseases
PreFER Managed Ventricular Pacing (MVP) For Elective Replacement
The purpose of this study is to demonstrate the benefit of MVP in pacemaker and implantable cardioverter defibrillator (ICD) patients with a history of right ventricular pacing.
- Trial name
- NCT00293241
- Testing
- Managed Ventricular Pacing programmed ON/OFF
- Where
- Netherlands
- Volunteers
- 630 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Preterm Birth
Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions
Use an electrical-inhibition (EI)/uterine pacemaker device similar to an electrical heart pacemaker to deliver a weak electrical current to the human uterus that will rapidly and safely inhibit the unwanted premature uterine…
- Trial name
- NCT00212446
- Testing
- Electrical Intervention (EI)
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- St. Luke's-Roosevelt Hospital Center
Left Ventricular Dysfunction
PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing
This study will be done in patients who require the implantation of a cardiac pacemaker (an electronic device that controls the heartbeat) for complete heart block (a heart rhythm abnormality resulting in a slow heart beat).
- Trial name
- PROTECT-PACE (NCT00461734)
- Testing
- RV lead placement site
- Where
- 18 sites in Australia, New Zealand and 1 more
- Volunteers
- 248 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Atrial Fibrillation
Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation
The primary objective of this study is to evaluate the effect of ranolazine and of low-dose dronedarone when given alone and in combination at different dose levels on atrial fibrillation burden (AFB) over 12 weeks of treatment.
- Trial name
- HARMONY (NCT01522651)
- Testing
- Ranolazine, Dronedarone
- Where
- 50 sites in United States, Germany and 5 more
- Volunteers
- 134 people
- Sponsor
- Gilead Sciences
Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines
Micra Transcatheter Pacing Study
The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.
- Trial name
- NCT02004873
- Testing
- Micra Pacemaker Implant
- Where
- 56 sites in United States, Australia and 17 more
- Volunteers
- 744 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
C.Surgical Procedure; Cardiac, Cardiac Dysrhythmia
Bridge Occlusion Balloon in Lead Extraction Procedure
To evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within the Superior Vena Cava in lead extraction patients.
- Conditions
- C.Surgical Procedure; Cardiac, Cardiac Dysrhythmia, Disorder of Pacing Function
- Trial name
- NCT02714153
- Testing
- Bridge Balloon
- Where
- 7 sites in United States
- Volunteers
- 23 people
- Sponsor
- Yale University
Cardiac Arrhythmia
SJM MRI Diagnostic Imaging Registry (IDE)
This study is a prospective, non-randomized, multi-center study of subjects implanted with an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices who are clinically…
- Trial name
- NCT02807948
- Testing
- Pacemaker, ICD, or CRT device
- Where
- 58 sites in United States
- Volunteers
- 189 people
- Sponsor
- Abbott Medical Devices
Congenital Disorder
Pacemaker Therapy in Adults With Congenital Heart Defects
Review the feasibility, safety and outcomes in adults with congenital heart disease who undergo pacemaker implantation for bradycardia, tachycardia or heart failure indications
- Trial name
- NCT00303511
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Emory University
Pacemaker Indication
Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker
The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and…
- Trial name
- NCT00916344
- Testing
- EVIA Pacemaker
- Where
- France
- Volunteers
- 175 people
- Sponsor
- Biotronik SE & Co. KG
Bradyarrhythmia
Safety and Efficacy Study of IPG Patient With Home Monitoring
The number of patients with implantable pulse generator (IPG) has steadily increased in Japan causing increment in number of in office follow-ups and greater burden on many hospitals.
- Trial name
- NCT01523704
- Testing
- BIOTRONIK Home Monitoring System, BIOTRONIK Home Monitoring System with In-office Follow-up
- Where
- Japan
- Volunteers
- 1,327 people
- Sponsor
- Biotronik Japan, Inc.
Chronic Heart Failure, Atrial Fibrillation
The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients.
To examine the effects of heart rate reduction on exercise capacity in control subjects and patients with chronic heart failure.
- Conditions
- Chronic Heart Failure, Atrial Fibrillation, Arrhythmia, Sinus
- Trial name
- TREPPE (NCT02247245)
- Testing
- Ivabradine, Atrial fibrillation
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- University of Leeds
Heart Diseases
APPROPRIATE - Rate Adaptive Pacing Sensor
The APPROPRIATE study will compare differences in functional capacity (peak VO2) between chronotropically incompetent patients randomized to receive rate responsive pacing driven by either the minute ventilation…
- Trial name
- APPROPRIATE (NCT00757666)
- Testing
- Rate adaptive pacemaker
- Where
- 2 sites in United States
- Volunteers
- 566 people
- Sponsor
- Boston Scientific Corporation
Arrhythmias, Cardiac
Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices
Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.
- Trial name
- NCT01130896
- Where
- United States
- Volunteers
- 1,509 people
- Sponsor
- Johns Hopkins University
Device Replacement, Elective Replacement (ERI)
REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
The objective of this study is to prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a…
- Conditions
- Device Replacement, Elective Replacement (ERI), Device Advisory, Device Upgrade
- Trial name
- REPLACE (NCT00395447)
- Testing
- Straight-forward Device Replacement, Device Replacement with Upgrade
- Where
- 71 sites in United States
- Volunteers
- 1,744 people
- Sponsor
- Biotronik, Inc.