Clinical trials: Conduction System Pacing
Syncope, Heart Block
Syncope: Pacing or Recording in the Later Years
Syncope affects about 50% of Canadians, is the cause of 1 - 2% of all emergency room visits, and probably is responsible for CDN $250 million in health care spending each year.
- Conditions
- Syncope, Heart Block, Conduction Disorder of the Heart
- Trial name
- Spritely (NCT01423994)
- Testing
- pacemaker, implantable loop recorder
- Where
- 17 sites in United States, Canada and 3 more
- Volunteers
- 120 people
- Sponsor
- Canadian Institutes of Health Research (CIHR)
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
Atrial Fibrillation, Bradycardia
Prospective Registry of Pacemaker Patients Concerning Percentage of Right Ventricular Pacing, LVEF and NYHA Class
This registry is a data collection on patients who are implanted for more than 6 months with a pacemaker. Frequency and distribution of right ventricular pacing, NYHA class and left ventricular ejection fraction shall be…
- Conditions
- Atrial Fibrillation, Bradycardia, Heart Block, Sick Sinus Syndrome
- Trial name
- NCT00292539
- Testing
- Any pacemaker with right ventricular pacing option
- Where
- Germany
- Volunteers
- 600 people
- Sponsor
- Guidant Corporation
Atrio-Ventricular Block
Efficacy and Safety of Left Bundle Area Pacing Vs Right Ventricular Apical Pacing in Patients with Atrioventricular Block
This study will address whether LBBaP is superior to RVAP in terms of safety and efficacy
- Trial name
- NCT06674967
- Where
- Egypt
- Volunteers
- 42 people
- Sponsor
- Assiut University
Heart Block, Heart Block Complete
Effect of Site of Right Ventricular (RV) Pacing on RV Function, Left Ventricular (LV) Dyssynchrony and Contraction Efficiency
To evaluate RV systolic function and LV mechanical dyssynchrony and function in different lead position in the RV during permanent pacemaker implantation by using speckle tracking echocardiography (STE) and 3D volumetric ejection…
- Conditions
- Heart Block, Heart Block Complete, Systolic Function
- Trial name
- NCT06636851
- Testing
- Pacemaker and defibrillator
- Where
- Egypt
- Volunteers
- 52 people
- Sponsor
- South Valley University
AV Block, Bundle-Branch Block
Outcomes and Safety of Various Conduction System Pacing Methods
The aim of this study is to evaluate safety and clinical outcomes after different pacing approaches of conduction system pacing in a prospective registry.
- Conditions
- AV Block, Bundle-Branch Block, Atrial Fibrillation Rapid
- Trial name
- NCT04749836
- Testing
- His bundle pacing implantation, Left bundle branch area pacing implantation, Bachmann bundle pacing
- Where
- Slovenia
- Volunteers
- 150 people
- Sponsor
- University Medical Centre Ljubljana
Heart Failure, Congestive, Ventricular Fibrillation
Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation
The purpose of this study was to determine if cardiac resynchronization therapy when combined with defibrillation is safe and effective in the treatment of symptomatic heart failure.
- Conditions
- Heart Failure, Congestive, Ventricular Fibrillation, Tachycardia, Ventricular
- Trial name
- NCT00387803
- Testing
- Cardiac Resynchronization Therapy with Defibrillation
- Where
- United States
- Volunteers
- 581 people
- Sponsor
- Boston Scientific Corporation
Tachyarrhythmia
Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
The LEADR study is designed to assess the safety and efficacy of the Next Generation ICD lead. The LEADR LBBAP study is being conducted under the existing US FDA Investigational Device Exemption (IDE) for the Next Generation ICD…
- Trial name
- NCT04863664
- Testing
- Defibrillation (RV Implant), Defibrillation (LBBAP Implant)
- Where
- 55 sites in United States, Australia and 18 more
- Volunteers
- 998 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Left Bundle Branch Area Pacing
CSP-SOLIA-REGISTRY
The CSP Registry is a prospective, multicenter, observational, real-world study designed to evaluate the acute feasibility and long-term performance of the Solia CSP lead in Brazilian patients with a clinical indication for…
- Trial name
- NCT07808554
- Testing
- Solia CSP S Lead
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Hospital SOS Cardio
Bradycardia
Conduction System Pacing With INGEVITY+
The study is intended to evaluate the safety and effectiveness of the Boston Scientific INGEVITY+ cardiac pacing lead when implanted in the left bundle branch area (LBBA).
- Trial name
- INSIGHT-LBBA (NCT06014866)
- Testing
- Cardiac pacing
- Where
- 8 sites in United States
- Volunteers
- 1,383 people
- Sponsor
- Duke University
Ventricular Tachycardia
Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)
Medtronic is sponsoring the Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS) to further confirm safety and effectiveness of ventricular iATP therapy in routine clinical practice, following commercial release of…
- Trial name
- NCT04496518
- Testing
- Intrinsic Antitachycardia Pacing (iATP) Therapy
- Where
- 92 sites in United States, France and 7 more
- Volunteers
- 2,200 people, healthy volunteers welcome
- Sponsor
- Medtronic
AVB - Atrioventricular Block
Left Bundle Branch Pacing Versus Right Ventricular Pacing in Patients With Atrioventricular Block
Although emerging evidence demonstrated that left bundle branch pacing (LBBP) is a promising alternative for patients with either a bradycardia or a heart failure pacing indication.
- Trial name
- NCT05722379
- Testing
- left bundle branch pacing (LBBP), Right ventricular pacing (RVP)
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- West China Hospital
Complete AV Block, Sick Sinus Syndrome
Left Ventricular Pacing to Avoid Cardiac Enlargement Study
In this study, the investigators will examine whether left ventricular pacing is superior to right ventricular apical pacing in preventing deterioration of left ventricular systolic function and cardiac remodeling in patients…
- Trial name
- LVPACE (NCT01302717)
- Testing
- LV pacing, RV pacing
- Where
- 2 sites in South Korea
- Sponsor
- Seoul National University Hospital
Cardioneuroablation, Permanent Pacemaker Implantation
Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome
Different studies for cardiac ganglionated plexus（GP） ablation to treat vagal vascular syncope, sinus node dysfunction, and functional atrioventricular block have been published.
- Conditions
- Cardioneuroablation, Permanent Pacemaker Implantation, Sick Sinus Syndrome, Ganglionated Plexus
- Trial name
- GAPS (NCT04149886)
- Testing
- cardiac ganglion plexus ablation(cardioneuroablation), Permanent pacemaker implantation
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- China National Center for Cardiovascular Diseases
Right Bundle-Branch Block, Heart Failure With Reduced Ejection Fraction
Bifocal Right Ventricular PAcing in Right Bundle Branch blocK and Heart Failure With Reduced Ejection Fraction. The Study Tests the Superiority of Right Ventricular Bifocal Stimulation Over VVI Implantable Defibrillator in Right Bundle Branch Block and Heart Failure.
RATIONALE: Cardiac resynchronization therapy (CRT) is known to improve cardiac performance and to reduce morbidity and mortality in reduced-ejection fraction heart failure (HFrEF) despite optimal medical therapy (OMT).
- Conditions
- Right Bundle-Branch Block, Heart Failure With Reduced Ejection Fraction, Bifocal Stimulation
- Trial name
- BiPARK-HF (NCT03524001)
- Testing
- Compare VVi mode versus DDD bifocal stimulation through crossover randomization
- Where
- Italy
- Volunteers
- 13 people
- Sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
Atrial Fibrillation, Tachycardia, Supraventricular
Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
The purpose of this study is to find out if specialized programs in the AT500 and EnRhythm pacemakers will reduce the number of irregular heartbeat in the upper chamber of the heart and reduce symptoms (such as shortness of…
- Conditions
- Atrial Fibrillation, Tachycardia, Supraventricular, Arrhythmia, Bradycardia
- Trial name
- NCT00289289
- Testing
- Intervention Pacing Features
- Where
- 38 sites in United States, Canada
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia, Conduction Block, Atrioventricular
LLL vs. SDL for LBBP: A Non-inferiority RCT
Left Bundle Branch Pacing (LBBP) has emerged as one of the most commonly used physiological pacing modalities in clinical practice.
- Trial name
- NCT07378124
- Testing
- SDL implantation, LLL implantation
- Where
- China
- Volunteers
- 288 people
- Sponsor
- Ningbo No.2 Hospital
Arrhythmia, Bradycardia
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival…
- Conditions
- Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia
- Trial name
- PPR (NCT00271180)
- Testing
- Device
- Where
- 333 sites in United States, Australia and 33 more
- Volunteers
- 20,000 people
- Sponsor
- Medtronic