Clinical trials: Pacemaker
Disorder of Cardiac Pacemaker System
Evaluation Of Pacemakers in Children
Pacemakers were introduced into clinical practice several decades ago and currently are used in a growing number of patients. Since insertion of the first cardiac Pacemaker in 1958, vast changes have occurred in both the…
- Trial name
- NCT04163770
- Testing
- caliberation of pacemaker
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Assiut University
Ventricular Tachycardia, Arrythmia
Rook Epicardial Access Device Study
The purpose of this study is to confirm the efficacy and safety of the Talon Surgical Rook® Epicardial Access Kit as a pericardial access device.
- Trial name
- NCT03427333
- Testing
- The Rook® Epicardial Access Kit
- Where
- Czechia
- Volunteers
- 13 people
- Sponsor
- Talon Surgical
Need for MRI Imaging With Pacemaker or, Implantable Cardioverter Defibrillator Implanted
The MagnaSafe Registry: Determining the Risks of Magnetic Resonance Imaging (MRI) in the Presence of Pacemakers and Implantable Cardioverter Defibrillators (ICDs)
This study will create a registry of patients with pacemakers and implantable ICDs who will undergo clinically indicated MRI and will document the incidence of any adverse events or changes in device parameters that might be…
- Trial name
- MagnaSafe (NCT00907361)
- Testing
- MRI with pacemaker or ICD
- Where
- 21 sites in United States
- Volunteers
- 2,039 people
- Sponsor
- Scripps Health
Arrhythmia, Cardiac Implantable Electronic Device
Virtual Reality in Electrophysiological Procedures and Device Implantation: the VR inEP Trial
Each year about 37,000 patients undergo a catheter ablation to treat cardiac arrhythmias or have a cardiac device such as a pacemaker or implantable cardioverter defibrillator implanted in the Netherlands.
- Conditions
- Arrhythmia, Cardiac Implantable Electronic Device, Ablation of Arrhythmias, Electrophysiologic Study
- Trial name
- VR inEP (NCT07105241)
- Testing
- VR therapy, 360 degree education videos
- Volunteers
- 115 people
- Sponsor
- Radboud University Medical Center
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)
Sinus Bradycardia
Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia
This is a multicenter randomized controlled study. By comparing patients with sinus bradycardia undergoing cardiac autonomic ganglion ablation and pacemaker therapy, and long-term follow-up to evaluate its safety and…
- Trial name
- NCT05021627
- Testing
- Cardiac autonomic nerve modification, Pacemaker implantation
- Volunteers
- 240 people
- Sponsor
- Shanghai Chest Hospital
Bradycardia, Heart Failure
Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
The study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt…
- Trial name
- NCT06018818
- Testing
- Amvia/Solvia pacemaker family
- Where
- 3 sites in Austria, Germany
- Volunteers
- 129 people
- Sponsor
- Biotronik SE & Co. KG
Wound, Cardiac Arrhythmia
ZIPS Study - Zip Incision aPproximation vs. Suture
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair.
- Trial name
- ZIPS (NCT02213510)
- Testing
- Zip Surgical Skin Closure Device, Standard Suture Closure
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of California, San Diego
Pacemaker DDD
Right Ventricular Septal Versus Apical Pacing: Echocardiographic Study
This study aims to compare the effect right ventricular apical versus septal pacing on left ventricular function by deformation imaging using 2D speckle tracking echocardiography.
- Trial name
- NCT06045143
- Testing
- Patients undergoing DDD pacemaker implantation
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Assiut University
Pacemaker, Leadless Pacemaker
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
The registry for leadless pacemakers will collect and annually analyze the data of all leadless pacemaker implantations at the University Hospital St.
- Conditions
- Pacemaker, Leadless Pacemaker, Cardiac Pacing, Artificial, Registries
- Trial name
- LPR (NCT07246135)
- Where
- Austria
- Volunteers
- 700 people
- Sponsor
- Karl Landsteiner University of Health Sciences
Ventricular Flutter, Atrioventricular Block
Pacemaker Utilization and Ventricular Pacing in Patients Undergoing Trans-catheter Aortic Valve Replacement (TAVR)
The purpose of this study is to assess the incidence (at 90-days) of ventricular pacing in patients undergoing permanent pacemaker placement after TAVR.
- Conditions
- Ventricular Flutter, Atrioventricular Block, Intraventricular Conduction Delay, Bundle Branch Block
- Trial name
- PPM in TAVR (NCT02994667)
- Testing
- Permanent Pacemaker Placement
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Baylor Research Institute
Arrhythmia, Atrial Fibrillation
The Atrial High Rate Episodes in Pacemaker Patients
Prospective study assessing the incidence of atrial high rate episodes (AHRE) in pacemaker patients with and without previously diagnosed AT.
- Conditions
- Arrhythmia, Atrial Fibrillation, Atrioventricular Block, Bradycardia
- Trial name
- NCT00627328
- Where
- 42 sites in United States, Australia and 1 more
- Volunteers
- 427 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Post-operative Pain
A Trial Assessing The Association Between Type Of Local Anesthesia Treatment And Postoperative Pain In Patients In Having Undergone Arrhythmia Surgery
The goal of the proposed study is to investigate the relationship between two standard treatments, lidocaine or a mixture of lidocaine and bupivacaine, and 1) postoperative pain, and; 2) narcotic use following pacemaker or…
- Trial name
- NCT01300377
- Testing
- Bupivacaine / Lidocaine, Lidocaine
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Baylor Research Institute
Bradycardia
Assessment of Intracardiac Electrograms Transmitted by Home Monitoring for the Remote Follow-up of Pacemaker (PREMS)
The purpose of the PREMS study is to evaluate the capability of the periodic IEGM feature (intracardiac electrogram) to provide more extensive remote information about cardiac rhythm, sensing and capture, and thus to detect…
- Trial name
- PREMS (NCT02174484)
- Where
- 49 sites in France
- Volunteers
- 571 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure, Systolic
Optimising Pacemaker Therapy Using Multi-point Pacing (the OPT-MPP Study)
Recently, the introduction of quadripolar left ventricular leads (one with four pacing poles) has allowed the opportunity to pace the lateral (back) of the heart from several points at once using a single lead (multi-point pacing…
- Trial name
- OPT-MPP (NCT03220659)
- Testing
- Multi-point pacing, Standard settings
- Where
- United Kingdom
- Volunteers
- 23 people
- Sponsor
- University of Leeds
Device Related Infection
Antibiotic PRophylAxis Based on infeCTIve Risk in Cardiac Implantable Electronic Device
This study was aimed at the evaluation of a new protocol of antibiotic prophylaxis, stratified according to individual infective risk calculated with the Shariff score at the moment of cardiac implantable electronic device (CIED)…
- Trial name
- PRACTICE (NCT04736979)
- Testing
- amoxicillin clavulanate
- Volunteers
- 1,044 people
- Sponsor
- University Hospital of Ferrara
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
Bradycardia, Heart Block
Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of Apical and Alternative Position
This study is a long-term, prospective, and controlled evaluation of the mechanical dyssynchrony induced by right ventricular apical pacing, both in acute (spontaneous and stimulated) and chronic (12 and 24 months); the study…
- Conditions
- Bradycardia, Heart Block, Sick Sinus Syndrome
- Trial name
- NCT01647490
- Testing
- Permanent Cardiac Pacemaker Implantation
- Where
- 2 sites in Italy
- Volunteers
- 408 people
- Sponsor
- Ospedale Santa Maria di Loreto Mare
Heart Failure, Systolic
The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG
The purpose of this study is to evaluate if yoga practice will reduce cardiac sympathetic activity and subsequently cardiac arrhythmias.
- Trial name
- NCT03227393
- Testing
- Yoga training
- Where
- United States
- Sponsor
- University of Cincinnati
Atrial Fibrillation
Subclinical AtrIal FibrilLation and StrokE PreveNtion Trial
Introduction: Patients with atrial fibrillation (AF) have a substantial risk of stroke and systemic embolism. Subclinical AF is often suspected to be the cause of stroke in these patients.
- Trial name
- SILENT (NCT02004509)
- Testing
- Anticoagulant
- Where
- Brazil
- Volunteers
- 2,054 people
- Sponsor
- InCor Heart Institute