Clinical trials: Cardiac Implantable Electronic Device
Cardiac Implantable Electronic Devices, Quality of Life
Assessment of Validity and Reliability of the Turkish Version of the Quality of Life and Related Events Assessment Scale for Pacemaker Patients
Cardiac implantable electronic devices are widely utilized to lower the rates of morbidity and mortality from ventricular tachycardia and ventricular fibrillation, as well as the incidence of sudden cardiac death.
- Trial name
- NCT06775223
- Testing
- Cardiac implantable electronic devices
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people
- Sponsor
- Erol Olcok Corum Training and Research Hospital
Cardiomyopathy, Cardiac Arrhythmia
RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators
If a surgical sponge is mistakenly left inside a patient's body after a surgical procedure, it can cause a serious infection. To prevent this from happening, a new device has been developed that uses radiofrequency (RF) signals…
- Conditions
- Cardiomyopathy, Cardiac Arrhythmia, Heart Failure, Chronic Thromboembolic Pulmonary Hypertension
- Trial name
- RF (NCT02111980)
- Testing
- RF Assure Scanning
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Diego
Sick Sinus Syndrome, Complete Heart Block
Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.
The number of cardiac implantable electronic devices (CIEDs) implanted each year has grown rapidly over the past two decades. CIED infections, defined as infections involving the generator implant site (pocket) and/or…
- Conditions
- Sick Sinus Syndrome, Complete Heart Block, Syncope, Chronic Systolic Heart Failure
- Trial name
- ENVELOPE (NCT02809131)
- Testing
- polymixin/bacitracin, cephalexin, or levofloxacin, or clindamycin, Saline
- Where
- United States
- Volunteers
- 1,010 people
- Sponsor
- Vanderbilt University Medical Center
Cardiac Implantable Electronic Device Infection
Taurolidine Containing Antimicrobial CIED Wash to Prevent Infection
From January 1st 2020, any CIED procedure conducted with adjunct TauroPace™ CIED and pocket irrigation is enrolled in a consecutive manner and followed up in one centre. Follow-up is prospectively.
- Trial name
- NCT05576194
- Testing
- TauroPace, Hydrogen Peroxide, Taurolidine
- Where
- Germany
- Volunteers
- 1,417 people
- Sponsor
- Prof. Dr. Hendrik Bonnemeier
Infection Cardiac, Heart Failure
Tauropace to Prevent Cardiac Implantable Device Infections in Heart Failure Patients
The main purpose of the study is to evaluate the ability of the Tauropace to reduce major cardiac implantable electronic device (CIED) infections through 12-months post-procedure following CIED in heart failure participants.
- Conditions
- Infection Cardiac, Heart Failure, Cardiac Implantable Electronic Device Infections, High Risk
- Trial name
- TRICE-HF (NCT05103267)
- Testing
- Tauropace
- Where
- Italy
- Volunteers
- 500 people
- Sponsor
- Federico II University
Pacemaker Malfunction, Implantable Defibrillator Malfunction
Cardiac Implantable Electronic Device Magnetic Resonance Imaging Registry
This is a prospective registry evaluating the safety of performing magnetic resonance (MRI) scans on patients who have cardiac implanted electronic devices (CIEDs).
- Trial name
- CIED-MRI (NCT02459379)
- Testing
- MRI Scan
- Sponsor
- NYU Langone Health
Congestive Heart Failure
Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices
A relatively new and promising development in the area of cardiovascular implantable electronic device therapy is remote patient monitoring (RPM).
- Trial name
- REMOTE-CIED (NCT01691586)
- Testing
- Remote patient monitoring, In-Clinic check-ups
- Where
- Netherlands
- Volunteers
- 600 people
- Sponsor
- UMC Utrecht
Cardiac Implantable Electronic Device Infection
TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD
The purpose of this study is to compare the incidence of cardiac implantable electronic device (CIED) infection and CIED mechanical complication after CIED replacement with a high-power cardiac implantable electronic device…
- Trial name
- Centurion (NCT01043705)
- Where
- 52 sites in United States
- Volunteers
- 1,262 people
- Sponsor
- TYRX, Inc.
Hematoma Postoperative, Cardiac Resynchronization Therapy Devices
Prevention of Pocket Hematoma After Implantation Cardiovascular Implanted Electronic Devices
As the number of implanted cardiovascular implanted electronic devices (CIEDs) increases, the incidence of their complications also grows.
- Conditions
- Hematoma Postoperative, Cardiac Resynchronization Therapy Devices, Compression Bandages
- Trial name
- NCT04389398
- Testing
- pocket compression fixation belt
- Volunteers
- 80 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
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
CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETIC
Perioperative Management of Patients With Cardiac Implantable Electronic Devices
Data on the perioperative management of patients cardiac implantable electronic devices (CIEDs) is limited and published guidelines rely mainly on the experience of the cardiologists and anesthesiologists who manage these…
- Trial name
- MAGNET (NCT02025738)
- Testing
- MAGNET APPLICATION, REPROGRAMING, NO ACTION
- Where
- Israel
- Volunteers
- 150 people
- Sponsor
- Rambam Health Care Campus
Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree
Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices
Objective: This clinical study employs a prospective, paired, self-controlled, non-inferiority, multicenter research design to assess the safety and efficacy of utilizing 5G cloud follow-up for CIED in parameters monitoring and…
- Conditions
- Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree, Heart Failure
- Trial name
- CIED-CARE (NCT06652750)
- Testing
- Routine Management, 5G Cloud Follow-up
- Where
- 2 sites in China
- Volunteers
- 688 people
- Sponsor
- The Third People's Hospital of Chengdu
Cardiac Implantable Electronic Device Implantation
Educational Intervention for Elderly Patients With Cardiac Implantable Electronic Devices and Their Family Caregivers
This study evaluated whether a Family-Centered Empowerment Model could improve health status and functional independence and reduce complications in older adults after cardiac implantable electronic device (CIED) implantation.
- Trial name
- NCT07857915
- Testing
- Family-Centered Empowerment Model (FCEM), Routine Care
- Where
- Iran
- Volunteers
- 80 people
- Sponsor
- Shahid Beheshti University of Medical Sciences
Pacemaker, Defibrillator
Remote Programming of Cardiac Implantable Electronic Devices 2
Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators need to be regularly and systematically interrogated and reprogrammed to ensure proper functioning.
- Conditions
- Pacemaker, Defibrillator, Telemedecine
- Trial name
- REACT 2 (NCT06272344)
- Testing
- Teleconsultation
- Where
- France
- Volunteers
- 36 people
- Sponsor
- University Hospital, Bordeaux
Heart Failure, Cardiac Implantable Electrical Devices
Seasonal Physical Activity in Patients With Heart Failure With Cardiac Implantable Electronic Devices
The aim of this observational study is to determine the effect of seasonal changes on physical activity levels in heart failure patients with cardiac implantable electronic devices.
- Conditions
- Heart Failure, Cardiac Implantable Electrical Devices, Physical Activities
- Trial name
- CIED (NCT07420088)
- Testing
- follow-up study
- Where
- Turkey (Türkiye)
- Volunteers
- 24 people
- Sponsor
- Erol Olcok Corum Training and Research Hospital
Cardiac Implantable Electronic Device Infection, Cardiovascular Infections
Improving Safety of Lead Extraction Procedures by Traction Force Sensing
Death and vascular tears occur in up to 1% of the patients undergoing lead extraction procedures. These complications are due to abnormal force vectors during the procedure.
- Trial name
- NCT03842124
- Testing
- Force gauge
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Mayo Clinic
Endocarditis, Bacterial
New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System
The goal of this randomized clinical trials is to ascertain the safety and efficacy of immediate reimplantation of cardiac electronic implantable devices in patients with endocarditis and device-infections, compared to standard…
- Trial name
- POET-PPM (NCT06250985)
- Testing
- Timing of reimplantation
- Where
- 5 sites in Denmark
- Volunteers
- 176 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Device-detected Atrial Fibrillation, Subclinical Atrial Fibrillation
Blood Clotting Markers and Heart Ultrasound in People With Device-Detected Atrial Fibrillation
The purpose of this observational study is to investigate whether blood tests related to blood clotting are associated with established clinical stroke risk scores, the total amount of device-detected atrial fibrillation recorded…
- Conditions
- Device-detected Atrial Fibrillation, Subclinical Atrial Fibrillation, Atrial High Rate Episodes
- Trial name
- DDAF-HEV (NCT07713615)
- Where
- Denmark
- Volunteers
- 222 people
- Sponsor
- Andreas Sjøholm-Christensen
Cardiac Implantable Electronic Device
Efficiency of Electronic Multimedia Intervention With the Cardiac Implantable Electronic Device.
In this study, we aim to design a multi-media model through e-book for preoperative care of CIED intervention, which can enhance the knowledges of patients, reducing the stresses and uncertainties before the intervention.
- Trial name
- NCT05688540
- Testing
- e book, traditional education booklet
- Where
- Taiwan
- Volunteers
- 36 people
- Sponsor
- National Taipei University of Nursing and Health Sciences
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