Clinical trials: Infections of Cardiac Electronic Implantable Devices
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
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
Cardiac Implantable Electronic Device (CIED)
Observational, Retrospective, Single-center Study Aimed at Evaluating Long-term Outcomes Following Transvenous Lead Extraction of Infected Cardiac Implantable Electronic Devices.
The study aims to review the centre experience in previous 20 years to understand clinical course of patients underwent TLE for lead and pocket infection, to better understand prognosis, re-implant indication, timing and…
- Trial name
- NCT07530107
- Volunteers
- 300 people
- Sponsor
- IRCCS Ospedale San Raffaele
Cardiac Implantable Electronic Device Infections
Assessment of Diagnostic and Therapeutic Practices for Cardiac Implantable Electronic Devices Suspected Infections in Nancy University Hospital
The frequency of cardiac implantable electronic devices (CIED) is constantly increasing. Devices infections are one of the most serious complications in terms of morbidity and mortality.
- Trial name
- NCT04501835
- Testing
- Diagnostic and treatment evaluation
- Where
- France
- Volunteers
- 184 people
- Sponsor
- Central Hospital, Nancy, France
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 Infections
Validation of Procalcitonin as a Biomarker Diagnosing CDI
Cardiac device infections (CDI), especially pocket infections, are difficult to be diagnosed. Device pocket infections are not associated with elevated white blood cell count. CRP is only assoziated with a low sensitivity.
- Trial name
- (DIRT II) (NCT05007158)
- Testing
- procalcitonin blood test
- Volunteers
- 200 people
- Sponsor
- Deutsches Herzzentrum Muenchen
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.
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
Infections, Wounds and Injuries
Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant
The purpose of this study is to learn how effective each of the two dressings, Silverlon® and AQUACEL® AG, are in preventing post cardiac implantable electronic devices (CIED) procedure wound infections.
- Trial name
- NCT02781779
- Testing
- Silverlon®, AQUACEL® AG
- Where
- United States
- Volunteers
- 147 people
- Sponsor
- Kansas City Heart Rhythm Institute
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
COVID-19, Atrial Fibrillation New Onset
Natural History of COVID-19-Related Atrial Fibrillation
The unCOVer-AF prospective, multicenter registry aims at determining the natural history of atrial fibrillation (AF) via continuous cardiac rhythm monitoring in patients with a first arrhythmic episode during COVID-19…
- Trial name
- unCOVer-AF (NCT04830774)
- Testing
- ILR, PMK, ICD
- Where
- 12 sites in United States, Belgium and 1 more
- Volunteers
- 200 people
- Sponsor
- Texas Cardiac Arrhythmia Research Foundation
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
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
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
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
Electrode Malfunction, Infections of Cardiac Electronic Implantable Devices
Safe Traction During Ongoing Lead Extraction Procedure (STOP)
The study will evaluate (in-vitro) the forces that are typically used for the extraction of pacemaker or defibrillator electrodes.
- Trial name
- STOP (NCT01847625)
- Testing
- simulator
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Deutsches Herzzentrum Muenchen
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
Post-Op Complication
A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery
The purpose and objectives of this study is to investigate whether reducing the existing arm restrictions on patients who receive Cardiac Implantable Electronic Devices (CIED) will result in an improved patient experience post…
- Trial name
- LENIENT (NCT04915261)
- Testing
- Lenient Arm Restriction, Strict Arm Restriction
- Where
- Canada
- Volunteers
- 6,300 people, healthy volunteers welcome
- Sponsor
- Ottawa Heart Institute Research Corporation
Transvenous Lead Extraction
Effectiveness, Complications, and Mortality of TLE in Patients.
The number of devices for cardiac pacing and defibrillation has increased in recent years. However, although they have improved in terms of quality and extended lifespan after implantation, they are not free from complications.
- Trial name
- EXTRACT (NCT05775783)
- Testing
- Transvenous lead extraction
- Where
- Poland
- Volunteers
- 702 people, healthy volunteers welcome
- Sponsor
- Medical University of Silesia