Clinical trials: Pacemaker Implantation
Pacemakers, Defibrillators
Efficacy and Safety in Pacemaker and Defibrillator Implantation Via Cephalic Versus Axillary Vein Access (CEPHAX)
This clinical trial evaluates the efficacy and safety of axillary versus cephalic venous access in the pacemakers and defibrillators implantation.
- Conditions
- Pacemakers, Defibrillators, Complication, Pacemaker Electrode Lead Fracture
- Trial name
- CEPHAX (NCT03860090)
- Testing
- Pacemaker implant, Defibrillator implant, AXILLARY VEIN ACCESS
- Where
- Spain
- Volunteers
- 240 people
- Sponsor
- Castilla-La Mancha Health Service
Sinus Node Dysfunction
Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction
This is a noncommercial, physician-initiated, monitored, multicenter, prospective randomized clinical trial, a proof-of-concept study, investigating a treatment strategy only.
- Trial name
- SANOK (NCT05196126)
- Testing
- Permament pacemaker implantation, Cardioneuroablation
- Where
- 4 sites in Poland
- Volunteers
- 60 people
- Sponsor
- Stec, Sebastian, MD, PhD, FESC
Pacemaker Implantation, ICD Implantation
Blocks Alternative to Sedation
Current practice is to implant cardiac electronic devices using intravenous sedation with midazolam and fentanyl, as well as local injection of anesthetic (1-2).
- Trial name
- NCT04842227
- Testing
- Nerve block
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Habib Khan
Pacemaker, Defibrillators, Implantable
Complications Following Pacemaker or Implantable Defibrillator Cardioverter (ICD) Implantation in Denmark
This study examines possible risk factors with regard to complications following pacemaker or implantable defibrillator cardioverter (ICD) implantation.
- Trial name
- NCT01138670
- Where
- Denmark
- Volunteers
- 5,500 people
- Sponsor
- University of Aarhus
Myocardial Infarction (MI), Pacemaker Implantation
Augmented Reality as Discharge Information for Hospitalized Cardiology Patients
The goal of this clinical trial is to find out whether a simple augmented reality tool provided at hospital discharge can improve patients' understanding of their care, adherence to treatment, and health outcomes, compared with…
- Conditions
- Myocardial Infarction (MI), Pacemaker Implantation, Heart Failure, Atrial Fibrillation (AF)
- Trial name
- RACAR (NCT07399379)
- Testing
- Augmented reality app
- Where
- Spain
- Volunteers
- 303 people
- Sponsor
- Hospital Universitario Getafe
Aortic Valve Stenosis
Upper Extremity Versus Lower Extremity Accessory Access Sites During Transcatheter Aortic Valve Implantation
The goal of this prospective, multicenter, investigator-initiated, randomized clinical trial is to assess the safety and efficacy of a 'minimally invasive, upper extremity' approach versus the standard 'lower extremity' approach…
- Trial name
- TAVIXS (NCT05672823)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 8 sites in Netherlands
- Volunteers
- 238 people
- Sponsor
- Radboud University Medical Center
Pacemaker, ICD
Monaldi Hospital Rhythm Registry
The study is a prospective registry. Consecutive patients with indications of implant / replacement or upgrade of pacemaker (PM), implantable cardioverter defibrillator (ICD), Implanted loop recorder (ILR) will be enrolled.
- Conditions
- Pacemaker, ICD, Implanted Loop Recorder
- Trial name
- NCT05072119
- Testing
- Device implantation
- Where
- Italy
- Volunteers
- 5,000 people
- Sponsor
- University of Campania Luigi Vanvitelli
Pacemaker, Implantable Cardioverter-defibrillator
Ultrasound-guided Axillary Versus Conventional Cephalic Venous Access for Implantation of Cardiac Devices
The implantation of cardiac electronic devices is a common procedure in the Electrophysiology Laboratory. The most commonly used venous access sites are the cephalic, the axillary and the subclavian vein.
- Trial name
- NCT04958369
- Testing
- Ultrasound-guided axillary venous access, Cephalic venous access
- Where
- Greece
- Volunteers
- 114 people
- Sponsor
- University Hospital of Patras
Leadless Pacemaker
Leadless Pacemaker Implantation Positions and Its Relationship with Procedure Efficacy and Complication
Leadless pacemakers (LP) are safe and effective alternatives to transvenous pacemakers in select patients. Advances in battery and electronics technology allow for the entire pacemaker system to be implanted into the right…
- Trial name
- NCT06692218
- Testing
- Leadless pacemaker
- Where
- Hong Kong
- Volunteers
- 196 people
- Sponsor
- Chinese University of Hong Kong
Heart Block, Heart Failure
Right Apical Versus Septal Pacing Trial
The purpose of this study is to examine whether RV (right ventricular)septal pacing has any effect on LV ( left ventricular) function than RV apical pacing in patients who require ventricular pacing.
- Trial name
- RASP (NCT00199498)
- Testing
- Apical RV lead placement, Septal RV lead placement
- Where
- Canada
- Volunteers
- 160 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
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
Leadless Pacemaker, Transthoracic Echocardiography
Ultrasound Guided Leadless Pacemaker Implantation
The leadless pacemaker is a novel pacing technology that has emerged in recent years. Compared with conventional lead pacemakers, its design avoids many complications associated with leads and pacemaker pockets, including lead…
- Trial name
- NCT07857330
- Testing
- Transthoracic echocardiography-guided, Conventional fluoroscopy-guided, Leadless pacemaker
- Volunteers
- 288 people
- Sponsor
- China National Center for Cardiovascular Diseases
Tachyarrhythmia
APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias
The goal of APART is the assessment of the therapeutic and preventive stimulation algorithms of the Medtronic AT500 and following devices in patients with atrial tachyarrhythmias and an indication for cardiac pacing according to…
- Trial name
- NCT00170274
- Testing
- Activation of preventive and therapeutic algorithms for treatment of AF, AF Prevention and Therapy Algorithms On
- Where
- 6 sites in Germany
- Volunteers
- 156 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Pacemaker, Artificial
Comparison Between Early and Late Mobilization After Cardiac Device Implantation
Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours.
- Trial name
- NCT03530904
- Testing
- mobilization
- Volunteers
- 400 people
- Sponsor
- Carmel Medical Center
Bundle-Branch Block, Left, Cardiac Failure
Prognosis of Patients With Compete Left Bundle Branch Block
The investigators sought to evaluate the morphological and functional changes, risk stratification and prognosis of patients of participants with compete left bundle branch block (CLBBB).
- Conditions
- Bundle-Branch Block, Left, Cardiac Failure, ICD/Pacemaker Implantation, Cardiovascular Magnetic Resonance Imaging
- Trial name
- NCT03096678
- Testing
- Cardiac Magnetic Resonance Imaging
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Pacemaker Implantation, Pocket Hematoma and Bleeding
Pocket Haematoma Prevention in Patients Who Required Implantation/Replacement of a Pacemaker or Implantable Cardiac Defibrillator. The PHP Study.
The aim of this study is to demonstrate the efficacy of fibrin sealant (Tissucol-Baxter) in preventing pocket haematoma and subsequent complications in patients undergoing pacemaker or ICD implantation/replacement which cannot…
- Conditions
- Pacemaker Implantation, Pocket Hematoma and Bleeding, Antiplatelet Therapy or Oral Anticoagulants
- Trial name
- PHP (NCT01127984)
- Testing
- tissucol, drainage system
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Careggi Hospital
Disorder of Cardiac Pacemaker System, Disorder of Implantable Defibrillator
Examination of Implant´s Safety in an Electronic and Magnetic Field Environment
The number of active electrical cardiac implants such as internal cardioverter defibrillators (ICDs), pacemakers or cardiac contractility modules (CCM) has significantly risen over the last two decades.
- Conditions
- Disorder of Cardiac Pacemaker System, Disorder of Implantable Defibrillator, Cardiac Arrhythmia
- Trial name
- FEMU (NCT01626261)
- Testing
- Magnetic and electric field´s impact on the implant
- Where
- Germany
- Volunteers
- 281 people
- Sponsor
- RWTH Aachen University
Arrhythmias, Cardiac, Venous Puncture
Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI TRIAL
Single center, randomized trial (1:1 fashion) to asses the safety and the feasibility of the ultrasound guided venous puncture vs standard fluoroscopic technique in patients undergoing pacemaker or implantable…
- Conditions
- Arrhythmias, Cardiac, Venous Puncture, Implantable Defibrillator User, Pacemaker Complication
- Trial name
- ZEROFLUOROAXI (NCT05101720)
- Testing
- Ultrasound Guided Axillary Venous Access, Fluoroscopy-Guided Axillary Venous Access
- Where
- Italy
- Volunteers
- 280 people
- Sponsor
- University Hospital of Ferrara
Atrioventricular Block
Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block
The TELE-SPACER study is a multicenter, noncommercial, physician-initiated, proof-of-concept, prospective, randomized, controlled, unblinded clinical trial and registry designed to compare two methods of treatment of patients…
- Trial name
- TELE-SPACER (NCT05774262)
- Testing
- Pacemaker implantation, Cardioneuroablation (CNA)
- Where
- 2 sites in Poland
- Volunteers
- 300 people
- Sponsor
- American Heart of Poland
Leadless Pacemaker, Same-day Discharge
Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE
Leadless pacemakers (LP) are associated with a lower risk of revision compared with transvenous pacemakers. However, LPs implantation is associated with a 0.6% risk of complication at the femoral vein puncture site (e.g.
- Trial name
- VAMPIRE (NCT06455566)
- Testing
- Leadless pacemaker implantation through right internal jugular vein
- Where
- 13 sites in France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Caen