Clinical trials: Cardiac Pacing
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
Congestive Heart Failure
Effect of Bi-ventricular Pacing on Autonomous Nervous System
Patients with congestive heart failure are often associated with delayed intraventricular depolarization which causing dyssynchrony and an inefficient pattern of left ventricular contraction.
- Trial name
- NCT00190138
- Testing
- Bi-ventricular pacing
- Sponsor
- Far Eastern Memorial Hospital
Congestive Heart Failure
The Effect of Left Ventricular Filling Pressure on Pulmonary Clearance of Free Radical Loaded White Blood Cells and Platelets in Congestive Heart Failure Patients Before and After Biventricular Pacing
1. To assess whether a correlation exist between the degree of pulmonary clearance of free radical positive white bloodcells and platelets and the degree of pulmonary congestion in congestive heart failure (CHF) patients 2.
- Trial name
- OXIS-PACING (NCT00716885)
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Amsterdam UMC, location VUmc
Congenital Complete Atrioventricular Heart Block, High Grade Atrioventricular Block
Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block
Recent studies have shown that chronic stimulation of the right ventricle can cause deleterious effects to cardiac function and synchronicity.
- Conditions
- Congenital Complete Atrioventricular Heart Block, High Grade Atrioventricular Block, Postoperative Complete Heart Block
- Trial name
- NCT01477658
- Where
- Brazil
- Volunteers
- 140 people
- Sponsor
- University of Sao Paulo
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
Congenital Heart Disease (CHD)
Biventricular Pacing in Children With Congenital Heart Disease
Surgery with cardiopulmonary bypass (CPB) for congenital heart disease (CHD) causes low cardiac index (CI). With the increasing success of surgery for CHD, mortality has decreased and emphasis has shifted to post-operative…
- Trial name
- NCT02644824
- Testing
- Biventricular Pacing (BiVp)
- Where
- Canada
- Volunteers
- 43 people
- Sponsor
- The Hospital for Sick Children
Cardiomyopathy, Hypertrophic
Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy
DDD pacing improves symptoms and relieves LV outflow tract (LVOT) obstruction in most patients with hypertrophic cardiomyopathy (HCM).
- Trial name
- NCT00001530
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Pacemakers
PACE30: 30 Years in Cardiac Pacing
Limited data exist regarding temporal trends in permanent pacemaker (PPM) implantation. To describe trends in incidence and comorbidities of PPM recipients, the investigators aim to conduct a retrospective population-based cohort…
- Trial name
- PACE30 (NCT01086098)
- Volunteers
- 5,000 people
- Sponsor
- University of Dundee
Heart Failure
Placement of CS/LV Pacing Leads With EnSite NavX Guidance
This study utilizes the 3D mapping capabilities of the EnSite NavX mapping system to help guide the placement of the left ventricular lead during cardiovascular resynchronization therapy implant procedures with the goal of…
- Trial name
- NCT00577187
- Testing
- EnSite NavX-Guided CRT implant
- Where
- United States
- Sponsor
- Abbott Medical Devices
Heart Failure, CRT and/or ICD
Evaluation of Electrical and Hemodynamic Effects of Different Pacing Strategies in CRT Candidates
Heart failure patients with delayed electrical activation of the heart often benefit from cardiac resynchronization therapy (CRT). However, traditional CRT using biventricular pacing is not effective in all patients.
- Trial name
- NCT07032064
- Testing
- Sequential ventricular pacing at five sites
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Shanghai Zhongshan Hospital
Pacemaker, Artificial, Cohort Studies
Morbidity, Mortality and Gender Differences in Patients With Pacemakers
Previous publications suggest gender difference in outcome parameters after pacemaker implantation. Aim of this study is to investigate gender differences in patients with pacemaker.
- Conditions
- Pacemaker, Artificial, Cohort Studies, Arrhythmias Requiring Therapy, Cardiac Pacing, Artificial
- Trial name
- NCT03388281
- Testing
- No intervention, retrospective analysis only.
- Volunteers
- 11,444 people
- Sponsor
- Medical University of Vienna
Sudden Cardiac Death
Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
The aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.
- Trial name
- Prediction (NCT00560768)
- Testing
- Ovatio VR 6250 or DR6550
- Where
- 30 sites in United States, Canada and 2 more
- Volunteers
- 198 people
- Sponsor
- LivaNova
Heart Failure
Personalized CRT - MPP Post Approval Study
The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release.
- Trial name
- NCT03232944
- Testing
- Cardiac Resynchronization Therapy - MPP
- Where
- 78 sites in United States, Belgium and 11 more
- Volunteers
- 1,338 people
- Sponsor
- Medtronic
Pacemaker, Bradycardia
Adapta Pacing System Clinical Study
Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow).
- Trial name
- NCT00307073
- Testing
- Implantable Pulse Generator
- Where
- 7 sites in Austria, Czechia and 4 more
- Volunteers
- 120 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
Heart Failure
Pacing in Heart Failure With Preserved LVEF
A random-order cross-over pilot trial of a CE marked device (pacemaker) outside its current intended purposes. The study will comprise 10 patients.
- Trial name
- MAPPLE (NCT03215849)
- Testing
- CRT-pacemaker device set to Routine Medical Therapy, CRT-pacemaker device set to Routine Medical Therapy + LVP, CRT-pacemaker device set to Routine Medical Therapy + BiVP
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Cardiff and Vale University Health Board
Arrhythmia, Bradycardia
CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse
This study compares the pacemaker's automatic pacing threshold measurements to the manual measurements conducted by a health care provider.
- Trial name
- NCT00275769
- Testing
- Pacemaker
- Where
- 57 sites in United States, Canada
- Volunteers
- 860 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia
Clinical Investigation of the SelectSecure Pacing Lead
People who have a slow heart beat, or whose heart does not beat on its own, may be in need of an electronic device called a pacemaker. A pacemaker is implanted surgically just under the skin in the upper chest area.
- Trial name
- NCT00266682
- Testing
- Pacing Lead
- Where
- 31 sites in United States, Australia and 1 more
- Volunteers
- 365 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Dilated Cardiomyopathy, Ischemic Cardiomyopathy
Optimized Biventricular Pacing Allograft Recipients
This study tests optimization of biventricular pacing (BiVP) in patients with dilated cardiomyopathy (DCM) or ischemic cardiomyopathy (ICM) during cardiac transplantation in patients with advanced cardiac failure.
- Trial name
- BiBET (NCT01290822)
- Testing
- BiVP, AAI Pacing
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Henry M. Spotnitz