Clinical trials: Cardiac Implantable Electronic Device (CIED)
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
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
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.
Cardiac Rhythm Disorder
3T MRI CIED Post-Approval Study
The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure.
- Trial name
- NCT02969395
- Where
- 204 sites in United States, Belgium and 20 more
- Volunteers
- 41 people
- Sponsor
- Medtronic
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
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
CIED Related Infection
World-wide Randomized Antibiotic Envelope Infection Prevention Trial
Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study.
- Trial name
- WRAP-IT (NCT02277990)
- Testing
- TYRX™ Absorbable Antibacterial Envelope
- Where
- 181 sites in United States, Austria and 23 more
- Volunteers
- 7,075 people, healthy volunteers welcome
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Safety of MRI
Safety of Magnetic Resonance Imaging With Patients Who Have Mixed Lead Cardiac Implantable Electronic Devices
This study is looking at the safety and efficacy of using MRIs with patients who have cardiac implantable electronic devices.
- Trial name
- MRIMLD (NCT07155135)
- Testing
- MRI
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Socal Heart
Atrial Fibrillation
Apixaban in Patients Who Undergo CIED Procedure- Randomized Pilot Study
This study is being done to determine if apixaban is more safe, when compared to warfarin, at reducing the risk of bleeding during CIED procedures.
- Trial name
- Apixaban (NCT02450682)
- Testing
- Apixaban, Warfarin
- Where
- United States
- Sponsor
- Mayo Clinic
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
Wound, Cardiac Arrhythmia
ZIPS Study - Zip Incision aPproximation vs. Suture
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair.
- Trial name
- ZIPS (NCT02213510)
- Testing
- Zip Surgical Skin Closure Device, Standard Suture Closure
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of California, San Diego
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
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
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.
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
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
Magnetic Resonance Imaging (MRI)
Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Following Magnetic Resonance Imaging
Researchers are trying to determine if heart injury occurs in subjects with cardiac implantable electronic device (CIED), such as a pacemaker or implantable cardioverter defibrillator (ICD), who undergo a magnetic resonance…
- Trial name
- NCT04151953
- Testing
- Blood sample collection
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- Mayo Clinic
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
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
Infections
CIED Infection Quality Initiative Demonstration Project
The aim of this Quality Initiative (QI) demonstration project is to develop a model to increase guideline-driven care for patients with cardiovascular implantable electronic devices (CIED) infection.
- Trial name
- RECTIFY (NCT05471973)
- Testing
- Multidisciplinary Team, Outreach Visits, Multifaceted Intervention
- Where
- 3 sites in United States
- Volunteers
- 200 people
- Sponsor
- Duke University