Clinical trials: Cardiac Implantable Electronic Device
Pain Management
Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain
Bupivacaine is the most widely used local anesthetic agent across majority of the Cardiac Implantable Electronic device (CIED) implant procedures in the United States.
- Trial name
- NCT05575999
- Testing
- Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination
- Where
- 3 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Kansas City Heart Rhythm Research Foundation
Cardiac Arrhythmia
Comparing Sensitivity and Specificity of Pacemaker ID Application and Cardiac Rhythm Management Device-Finder Application.
Smart phone-based applications to identify cardiac implantable electronic devices (CIED) are extremely useful in circumstances where urgent device interrogation is needed and device identification card is not available.
- Trial name
- NCT04957108
- Testing
- Device identification using Xray.
- Where
- Pakistan
- Volunteers
- 547 people, healthy volunteers welcome
- Sponsor
- Aga Khan University Hospital, Pakistan
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
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
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
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
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