Clinical trials: Pacemaker Complication
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
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
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
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
Complication of Surgical Procedure, Pacemaker Complication
Key Factors of Leadless Pacemaker Implantation With Implantation Site, Complications and Prognosis
To investigate the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis.
- Conditions
- Complication of Surgical Procedure, Pacemaker Complication, Pacemaker Syndrome
- Trial name
- NCT05761821
- Testing
- Leadless pacemaker
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Pacemaker Complication, Mobilization
Early Mobilization After Pacemaker Implantation.
Permanent pacemaker implantation is one of the most common arrhythmological procedure. This procedure is usually accompanied by a minimum of 2-3 days hospitalization, with immobilization of patients (supine) for 16-24 hours.
- Trial name
- EMAPI (NCT04111354)
- Testing
- Pacemaker implantation
- Where
- Czechia
- Volunteers
- 200 people
- Sponsor
- Charles University, Czech Republic
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
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
Bradycardia
Complications Following Pacemaker Implantation
This study examines possible risk factors with regard to complications following pacemaker implantation.
- Trial name
- NCT01038180
- Where
- Denmark
- Volunteers
- 28,000 people
- Sponsor
- University of Aarhus
Tricuspid Regurgitation, Pacemaker Complication
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only.
- Trial name
- PLACE (NCT05667519)
- Testing
- Additional guidance of lead implantation by transesophageal echocardiography
- Where
- Germany
- Volunteers
- 324 people
- Sponsor
- LMU Klinikum
Postoperative Care After Cardiac Implantable Electronic Device Implantation
Effects of Short-Term Arm Sling Use After Cardiac Implantable Electronic Device Placement
This randomized controlled trial will evaluate the effects of short-term medical arm sling use during the first 24 hours after cardiac implantable electronic device (CIED) implantation on patient comfort, pain, satisfaction, and…
- Trial name
- CIED-SLING24 (NCT07810426)
- Testing
- Medical Arm Sling
- Volunteers
- 104 people
- Sponsor
- Tugba Yorulmaz
Arrhythmia, Heart Diseases
Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study
The overall objective of the study is to quantify the true prognostic value and cost-effectiveness of routine follow-up visits in patients who receive an approved pacemaker of any type for the first time.
- Trial name
- NCT00135174
- Where
- Netherlands
- Volunteers
- 1,526 people
- Sponsor
- UMC Utrecht
Pacemaker Complication, Infections
Impact of Partial Capsule Decortication on Device-related Infection in Patients Receiving Cardiac Implantable Electronic Device Replacement
Increasing number of cardiac implantable electronic devices (CIEDs) have been implanted in the worldwide every year, which is accompanied by the growing number of CIED-related infection, especially in patients with CIED…
- Trial name
- STERILE (NCT05390216)
- Testing
- Partial capsule decortication
- Where
- China
- Volunteers
- 1,016 people, healthy volunteers welcome
- Sponsor
- Shanghai Zhongshan Hospital
Hematoma Postoperative
Application of the "Haemoblock" in Pacemaker Patients
Pocket hematoma is a known complication of pacemaker (PM) implantation. Pocket hematoma is accompanied by a local discomfort associated with the infiltration of subcutaneous tissue.
- Trial name
- NCT04559646
- Testing
- Pacemaker implantation, Haemostatic solution "Haemoblock" application, Saline solution application
- Where
- Russia
- Volunteers
- 200 people
- Sponsor
- Ryazan State Medical University
Infection, Bacterial, Pacemaker Complication
Impact of Antibiotic Treatment Following Implantation of Cardiac Electronic Device on Patient's Outcome
Background: Infection of cardiac implantable electronic device including wound and pouch infection, bacteraemia and endocarditis is a common complication of device insertion.
- Trial name
- NCT03148444
- Testing
- cefalexin 500 mg qid or roxithromycin 150 mg bid
- Volunteers
- 400 people
- Sponsor
- Kaplan Medical Center
Late Complication From Cardiac Pacemaker Implantation
Effects of Right Ventricular Pacemaker Lead Position Assessed by MRI
Chronic right ventricular apical pacing has been associated with negative hemodynamic effects. Clinical outcome of right ventricular pacing can be influenced by multiple factors.
- Trial name
- NCT01682239
- Testing
- RVAP, RVSP
- Where
- Austria
- Volunteers
- 24 people
- Sponsor
- Medical University of Vienna
Cardiac Pacemaker Malfunction, ICD Malfunction
Perioperative Management Evaluation in Patients With CIED
Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives.
- Conditions
- Cardiac Pacemaker Malfunction, ICD Malfunction, Cardiac Pacemaker Electrical Interference, Anesthesia Complication
- Trial name
- EVINCE (NCT04331249)
- Testing
- surgery or catheter based cardiac procedure (catheter ablation)
- Where
- 2 sites in Germany
- Volunteers
- 500 people
- Sponsor
- Klinikum-Fuerth
Pacemaker Complication
A Major Determinant Focused on the ECG or Echocardiogram for PICM and Its Clinical Outcome (PICM Syndrome)
Chronic right ventricular pacing has a deleterious effect on left ventricular (LV) function, namely pacing-induced cardiomyopathy (PICM).
- Trial name
- NCT03475498
- Where
- 3 sites in South Korea
- Volunteers
- 1,000 people
- Sponsor
- Eulji University Hospital
Atrioventricular Synchrony by the Micra AV
French Cohort Evaluating the effectiveneSs of Atrioventricular Synchrony by the micRa AV
Transvenous cardiac pacemakers have pitfalls due to lead- and device pocket-related complications. Leadless pacemakers were developed and introduced into clinical practice to overcome the weaknesses of traditional transvenous…
- Trial name
- AV-CESAR (NCT05953558)
- Testing
- Patients implanted with Micra AV
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- Paris Sudden Death Expertise Center
Heart Failure, Pacemaker-Induced Cardiomyopathy
The PICM Risk Prediction Study - Application of AI to Pacing
Development of pacing induced cardiomyopathy (PICM) is correlated to a high morbidity as signified by an increase in heart failure admissions and mortality.
- Conditions
- Heart Failure, Pacemaker-Induced Cardiomyopathy, Pacemaker Complication
- Trial name
- NCT06449079
- Testing
- Machine learning
- Where
- 3 sites in United Kingdom
- Volunteers
- 10,000 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust