Clinical trials: Pacemaker Complication
Bradyarrhythmias, AV Block Complete
Belgo-Luxembourg Leadless PM Registry
This is a single-arm, multicenter clinical study evaluating the long-term effectiveness and safety profile of the CE-marked and commercially available Aveir leadless pacemaker systems manufactured by Abbott.
- Conditions
- Bradyarrhythmias, AV Block Complete, AV Block-2Nd Degree-Type 1, Pacemaker
- Trial name
- BELLA (NCT07879716)
- Testing
- CT scan heart, 24 hour ambulatory ECG monitoring
- Where
- 9 sites in Belgium, Luxembourg
- Volunteers
- 190 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
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
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
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, 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
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
Pacemaker Complication
Prophylactic Antibiotics Duration Towards Healing and Risk of Infection in Permanent Pacemaker (PPM) Installation
The insertion of a permanent pacemaker (PPM) is frequently a life-saving procedure. However, the implantation process could sometimes lead to a rare but serious infection.
- Trial name
- PACE-PRO (NCT06355115)
- Testing
- Cefazolin 1000 MG Injection
- Where
- Indonesia
- Volunteers
- 100 people
- Sponsor
- University of Brawijaya
Pacemaker Complication, Arrhythmias, Cardiac
Association of Obesity and Cardiovascular Outcomes in Patients With Pacemaker
In this study, the investigators evaluated the association between various measures of adiposity [BMI and waist circumference (WC)] and clinical outcomes in Asian patients who underwent pacemaker insertion, using a nationwide…
- Conditions
- Pacemaker Complication, Arrhythmias, Cardiac, Obesity, Cardiovascular Morbidity
- Trial name
- Paradox (NCT05645978)
- Testing
- Pacemaker insertion
- Where
- South Korea
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- Ajou University School of Medicine
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
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
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
Tricuspid Valve Insufficiency, Pacemaker Complication
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation Registry
Registry for patients undergoing pacemaker/ICD implantation including a transtricuspid lead with and without intraprocedural transesophageal echocardiography to evaluate risk factors for lead induced tricuspid regurgitation.
- Conditions
- Tricuspid Valve Insufficiency, Pacemaker Complication, Echocardiography, Transesophageal
- Trial name
- PLACE (NCT04945005)
- Testing
- Transesophageal guidance of lead implantation
- Where
- Germany
- Volunteers
- 124 people
- Sponsor
- LMU Klinikum
Left Ventricular Dysfunction, Heart Failure, Systolic
Reprogramming to Prevent Progressive Pacemaker-induced Remodelling
The aim is to provide evidence of the long-term benefits of personalised pacemaker programming on heart function and battery longevity.
- Conditions
- Left Ventricular Dysfunction, Heart Failure, Systolic, Left Ventricular Failure, Pacemaker; Complication, Mechanical
- Trial name
- PPPR (NCT03627585)
- Testing
- Personalised programming
- Where
- 2 sites in United Kingdom
- Volunteers
- 91 people
- Sponsor
- University of Leeds
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
Pacemaker Complication, Congestive Heart Failure
Optimised Pacing Program
Permanent pacemakers are a common treatment for slow heart beats. In the UK 300,000 people have a pacemaker, and each year another 36,000 receive them. All of these patients are usually seen yearly to have their device checked.
- Trial name
- OPT-pace (NCT01819662)
- Testing
- Enhanced standard management, Optimised heart failure management, Standard management
- Where
- 3 sites in United Kingdom
- Volunteers
- 1,793 people, healthy volunteers welcome
- Sponsor
- University of Leeds
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
Complication of Cardiac Defibrillator, Disorder of Cardiac Pacemaker System
Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator
The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.
- Conditions
- Complication of Cardiac Defibrillator, Disorder of Cardiac Pacemaker System, Venous Occlusion
- Trial name
- NCT02331511
- Testing
- Aspirin 80 mg daily, Clopidogrel 75 mg daily
- Where
- Iran
- Volunteers
- 100 people
- Sponsor
- Shahid Beheshti University of Medical Sciences
Mechanical Complication of Cardiac Pacemaker
Comparison of Axillary Vein Puncture With Subclavian Vein Puncture in Pacemaker Implantation
The intrathoracic subclavian venous technique for pacemaker implantation may be associated with serious complications. Axillary vein puncture tends to reduce lead implantation complications such as pneumothorax and lead crush…
- Trial name
- NCT02358551
- Testing
- Placement of electrode lead through axillary vein puncture, Placement of electrode lead through subclavian vein puncture
- Where
- China
- Volunteers
- 220 people
- Sponsor
- China-Japan Friendship Hospital
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