Clinical trials: Cardiac Pacing
Non-left Bundle Branch Block, Ischemic or Non-ischemic Cardiomyopathy
CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients
The purpose of this study is to analyze the effect of left ventricular lead pacing location in the non-left bundle branch block (non-LBBB) heart failure patient population.
- Trial name
- ENHANCE CRT (NCT01983293)
- Testing
- QLV based implant strategy, Standard of care implant strategy
- Where
- 32 sites in United States
- Volunteers
- 248 people
- Sponsor
- Abbott Medical Devices
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
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
Heart Failure
Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead
This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population.
- Trial name
- NCT00763698
- Testing
- QuickFlex Micro Model 1258T Left Heart Lead
- Where
- 13 sites in United States
- Volunteers
- 86 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Atrioventricular Block
BIOTRONIK Conduction System Pacing With the Solia Lead
The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia S pacing lead when implanted in the left bundle branch (LBB) area.
- Conditions
- Bradycardia, Atrioventricular Block, Left Bundle-Branch Block, Cardiomyopathies
- Trial name
- BIO-CONDUCT (NCT05251363)
- Testing
- Solia S lead
- Where
- 14 sites in United States
- Volunteers
- 194 people
- Sponsor
- Biotronik, Inc.
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
Bradyarrhythmia
Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086
Pacing leads are key elements of a pacing system as their proper functioning is one of the major factors affecting the long term performance of the whole system.
- Trial name
- NCT01522755
- Testing
- Pacing system implant with the CapsureFix MRI pacing lead model 5086
- Where
- France
- Volunteers
- 409 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
REmodeling the Left Ventricle With Atrial Modulated Pacing
New therapy tested in heart failure with preserved ejection fraction (HFpEF) patients with approved indications for pacing to determine if elevated pacing therapy is tolerated and whether there is a signal for efficacy.
- Trial name
- REVAMP (NCT03210402)
- Testing
- Elevated night pacing on, Elevated night pacing off
- Where
- 10 sites in United States
- Volunteers
- 22 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial
Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF) refractory to optimal medical management, in presence of a depressed left ventricular (LV) ejection fraction and a wide QRS complex.
- Trial name
- V3 (NCT01059175)
- Testing
- Additional Endocardial or Epicardial LV Lead, CRT-P or CRT-D
- Where
- France
- Volunteers
- 84 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiomyopathies, Congestive Heart Failure
Survey of QRS Frequency at Various Left Ventricular Pacing Sites for Cardiac Resynchronization
LV pacing at various sites with recording of ECG and subsequent signal analysis at different sites.
- Trial name
- NCT03253809
- Testing
- Biotronik Vision Guidewire
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- The Cleveland Clinic
Heart Failure
Biventricular Versus Right Ventricular Pacing
The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist…
- Trial name
- NCT06298669
- Testing
- Biventricular Pacing, Right Ventricular Pacing
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Indiana University
Aortic Valve Disease
Use of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery
The study is being done to determine if the Endovent pulmonary catheter kit, used for port access surgery, can be used as a passageway for a pacing wire.
- Trial name
- NCT01631188
- Testing
- Minimally Invasive Aortic Valve, Minimally Invasive Aortic Valve Surgery, Manipulation in OR surgical technique
- Volunteers
- 100 people
- Sponsor
- Rutgers, The State University of New Jersey
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, Pacing
Model 4965 Post-Approval Study
Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).
- Conditions
- Heart Failure, Pacing, Bradycardia, Arrhythmia
- Trial name
- NCT01076348
- Where
- 107 sites in United States, Australia and 12 more
- Volunteers
- 73 people
- Sponsor
- Medtronic
Tachycardia, Ventricular, Arrhythmia, Ventricular
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.
- Trial name
- MODULAR ATP (NCT04798768)
- Testing
- mCRM Therapy System
- Where
- 38 sites in United States, Austria and 7 more
- Volunteers
- 297 people
- Sponsor
- Boston Scientific Corporation
Left Ventricular Dysfunction
Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)
Prospective, multi-center, single arm, post approval study to be conducted in the United States.
- Trial name
- SMARTMSP (NCT03257436)
- Testing
- CRT-D
- Where
- 54 sites in United States
- Volunteers
- 586 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
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
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
Heart Failure
The His Optimised Pacing Evaluated for Heart Failure Trial (HOPE-HF).
This is a multi-centre, prospective randomised double-blinded cross over study, recruiting a sub-population of patients with heart failure.
- Trial name
- HOPE-HF (NCT02671903)
- Testing
- Pacemaker: AV optimised, His pacing.
- Where
- 15 sites in United Kingdom
- Volunteers
- 198 people
- Sponsor
- Imperial College London
Heart Failure With a Preserved Ejection Fraction, Heart Failure, Diastolic
Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure
Determine the impact of restoring normal heart rate response during exercise and daily activity in patients with heart failure and a preserved ejection fraction (HFpEF) and chronotropic incompetence (CI).
- Conditions
- Heart Failure With a Preserved Ejection Fraction, Heart Failure, Diastolic, Chronotropic Incompetence
- Trial name
- RAPID-HF (NCT02145351)
- Testing
- Rate adaptive atrial pacing using a dual-chamber pacemaker, Pacemaker system will be implanted but set to Pacing Off.
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Mayo Clinic