Clinical trials: Cardiac Implantable Electronic Device (CIED)
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
Tricuspid Regurgitation, CIED Implantation
3D Transthoracic Echocardiographic Evaluation on Tricuspid Regurgitation Progression and Clinical Outcomes in Patients With Cardiac Implantable Electronic Device
The goal of this observational study is to learn about the development and worsening of tricuspid regurgitation (TR) in patients who have cardiac implantable electronic devices (CIEDs).
- Conditions
- Tricuspid Regurgitation, CIED Implantation, Leadless Pacemaker, Pacemaker
- Trial name
- 3DECHO-TR (NCT07793916)
- Testing
- 3D Transthoracic echocardiographic evaluation
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Samsung Medical Center
CIED-related Infections, CIED Implantation
CIED Implantation Technique at Assiut University Heart Hospital in Relation to ESC Guidelines
This prospective observational cohort study will evaluate the extent to which cardiac implantable electronic device (CIED) implantation techniques at Assiut University Heart Hospital (AUHH) align with the evidence-based…
- Trial name
- NCT07210801
- Testing
- CIEDimplantation
- Volunteers
- 200 people
- Sponsor
- Assiut University
Cardiovascular Diseases (CVD), Cardiac Implantable Electronic Device (CIED)
EValuation of prognostIc and Cost reDuction by tElemonitoring iN CIEDs Usual carE: an Updated Analysis Using 2019-2023 Data
The EVIDENCE-RM study is a nationwide, non-interventional retrospective study evaluating the clinical and medico-economic impact of remote monitoring (RM) in patients with an implantable cardioverter-defibrillator (ICD) or…
- Trial name
- EVIDENCE-RM 2 (NCT07881250)
- Testing
- No RM exposure, RM exposure, Conventional RM
- Where
- France
- Volunteers
- 100,000 people
- Sponsor
- Implicity
Chronic Heart Failure
Interactive Patient's Assistant - LUCY
Patients with chronic heart failure (CHF) and reduced left ventricle ejection fraction benefit from cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD).
- Trial name
- NCT03474315
- Testing
- Multivariate assessment
- Where
- Poland
- Volunteers
- 600 people
- Sponsor
- Medical University of Warsaw
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
Right Ventricular Dysfunction
Right Ventricular Function Changes After CIED Implantation: The RIGHT-CIED Study
This study aims to understand how the right side of the heart changes in people who receive an implantable cardiac electronic device (CIED), such as a pacemaker, ICD, or CRT device.
- Trial name
- RIGHT-CIED (NCT07272395)
- Testing
- Multimodal Right Ventricular Evaluation
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Istanbul University - Cerrahpasa
Heart Block, CIED Related Infection
Biomarkers & Infection After Prophylactic Antibiotic in Cardiac Implantable Electronic Device Implantation
Effect of single dose \& intrapocket prophylactic antibiotic to cardiac implantable electronic device-related infection \& biomarkers
- Conditions
- Heart Block, CIED Related Infection, CIED-related Infections, Antibiotic Prophylaxis
- Trial name
- BI-PACED (NCT06448624)
- Testing
- Ampicillin sulbactam 3 days
- Where
- Indonesia
- Volunteers
- 60 people
- Sponsor
- Universitas Diponegoro
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
Complications, Infective Endocarditis
PET CT in Suspected CIED Infection, a Pilot Study - PET Guidance I
The aim of this single-center randomized controlled trial is to assess clinical usefulness of positron emission tomography combined with computed tomography (PET CT) in the diagnostic process of suspected cardiovascular…
- Conditions
- Complications, Infective Endocarditis, Implant Site Pocket Infection, Fever of Unknown Origin
- Trial name
- PET Guidance I (NCT02196753)
- Testing
- PET CT
- Where
- Poland
- Volunteers
- 40 people
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
Pain Measurement, Chronic Pain
Evaluation of Chronic Postsurgical Pain Risk in Patients Undergoing CIED Implantation Using an AID Support System
Chronic postsurgical pain (CPSP) remains a significant clinical and public health challenge despite major advances in surgical and anesthetic techniques.
- Conditions
- Pain Measurement, Chronic Pain, Cardiac Implantable Electrical Devices, Neuropathic Pain
- Trial name
- PAIN-AID (NCT07322900)
- Volunteers
- 180 people
- Sponsor
- Istanbul University - Cerrahpasa
C.Surgical Procedure, Stress
Music Therapy as an Adjunct in CIED Lead Extraction Procedures
The study will investigate possible effects of music therapy as an adjunct in an invasive cardiac procedure where infected or broken pacemaker leads, or leads from implantable cardioverter-defibrillators are removed from inside…
- Conditions
- C.Surgical Procedure, Stress, Pain, Procedural, Anxiety
- Trial name
- MATH (NCT04172662)
- Testing
- Facilitated Music Listening
- Where
- Norway
- Volunteers
- 68 people
- Sponsor
- Oslo University Hospital
Atrial Fibrillation
Comparison of the Performance of ICM and CIED in Detecting AF
The aim of this project is to study the performance of the two most commonly used Implantable Cardiac Monitors in detecting AF episodes and explore how the new connectivity can empower patients and improve patient care.
- Trial name
- ID-AF (NCT04940156)
- Testing
- Confirm Rx (Implantable Cardiac Monitor), Reveal LINQ (Implantable Cardiac Monitor)
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Oxford University Hospitals NHS Trust
Pacemaker, ICD
EMI and CIED: Is High Power Charging of Battery Electric Car Safe?
It is not known if the use of high power charging systems for electric vehicles may interfere with the functionality of implanted pacemakers and cardioverter-defibrillators.
- Trial name
- eCarII (NCT05361681)
- Testing
- Electromagnetic Field Exposure
- Where
- Germany
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Deutsches Herzzentrum Muenchen
Cardiac Implantable Electronic Device (CIED), Shoulder Dysfunction
Long-term Effects of Early Shoulder Exercise After CIED Implantation
Shoulder dysfunction frequently occurs after cardiac implantable electronic device (CIED) implantation, adversely affecting quality of life.
- Trial name
- NCT07496554
- Testing
- Structured Stretching and Strengthening Program, Standard Post-operative Care, Pendulum Exercise Protocol
- Where
- Turkey (Türkiye)
- Volunteers
- 89 people
- Sponsor
- Erzincan Binali Yildirim Universitesi
Cardiac Implantable Electronic Device Infection
Cardiac Implantable Electronic Device RemOval Versus Full CoUrse Medical Treatment
The CIEDOUT study is an open label randomized trial in patients with possible cardiac implantable electronic device (CIED) infection.
- Trial name
- CIEDOUT (NCT06323668)
- Testing
- Cardiac implantable electronic device extraction
- Where
- Denmark
- Volunteers
- 180 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Cardiovascular Diseases
Exercise Training in Women With Cardiac Devices
Cardiac implantable electronic devices (CIED) are established treatments for a variety of cardiac arrhythmias. Women with CIED have lower fitness and lower quality of life compared to men with CIED.
- Trial name
- CIED-EX (NCT05946304)
- Testing
- moderate-intensity continuous exercise training (MICT) group, high-intensity interval training (HIIT) group
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Hemorrhagic Complications, Hematoma
Safety and Efficiency of the PacePress to Prevent Hemorrhagic Complications in Patients Undergoing CIED Implantation.
PacePress medical device, by ensuring constant compression force and the ability to optimize it in the pocket area prevents/significantly reduces the risk of hemorrhagic complications, including but not limited to the operation…
- Conditions
- Hemorrhagic Complications, Hematoma, Hemorrhage, Pathologic Processes
- Trial name
- PacePress (NCT05292326)
- Testing
- PacePress, standard compression band
- Where
- 7 sites in Poland
- Volunteers
- 122 people
- Sponsor
- Medinice S.A.
Infection
Salvage of Infected Cardiovascular Implantable Electronic Devices (CIED) by Localized High-dose Antibiotics
Following previous positive experience with regulated CITA-RNPT of infected CIEDs, we suggest increasing the number of recruited patients and that CITA-RNPT can be administered prophylactically to patients prior to replacement of…
- Trial name
- NCT01770067
- Testing
- CITA-RNPT, Extraction of infected CIED
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Hillel Yaffe Medical Center
Non-valvular Atrial Fibrillation (NVAF), Thromboembolism
Stepwise vs Standard Anticoagulation for AF Patients Undergoing CIED Implantation (STEP-AF)
This is a multi-center, prospective, open-label, randomized controlled trial (STEP-AF) designed to evaluate the safety of a stepwise anticoagulation strategy compared with the guideline-recommended standard anticoagulation…
- Conditions
- Non-valvular Atrial Fibrillation (NVAF), Thromboembolism, Cardiac Implantable Electronic Device, Perioperative Bleeding
- Trial name
- STEP-AF (NCT07616414)
- Testing
- Stepwise Anticoagulation Regimen, Standard Anticoagulation Regimen
- Where
- China
- Volunteers
- 424 people
- Sponsor
- Fu Wai Hospital, Beijing, China