Clinical trials: Lead Extraction Procedures
Smoking Cessation, Smokeless Tobacco
In-vivo Extraction of Pb, Cd and TSNA From Swedish Snus
In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini".
- Conditions
- Smoking Cessation, Smokeless Tobacco, Harm Reduction
- Trial name
- SMWS03 (NCT01369693)
- Testing
- Buccal administration of nicotine
- Where
- Sweden
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Contract Research Organization el AB
Prosthesis-Related Infections, Equipment Failure
Medico-economic Evaluation of Strategies for the Lead Extraction of Implantable Defibrillator and Pacemakers
The growing use and the expanding indications for cardiovascular implantable electronic devices (CIEDs) have been associated to an increase of device removal.
- Conditions
- Prosthesis-Related Infections, Equipment Failure, Heart Failure, Arrhythmias
- Trial name
- GAINE LASER (NCT03121183)
- Testing
- Laser sheath, Implantable Cardiac Device lead extraction
- Where
- France
- Volunteers
- 45 people
- Sponsor
- University Hospital, Clermont-Ferrand
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
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
Bradycardia
Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.
This is an open label, interventional, feasibility, prospective, multicenter, clinical trial of lead extraction. The Xtrac O.S. system is intended for transvenous removal of pacing or defibrillator leads, having an inner lumen…
- Trial name
- XTR (NCT06115980)
- Testing
- lead extraction (Xtrac O.S. system)
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Xtrac O.S.
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
Device Malfunction, ICD
Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction
The purpose of this study is to prospectively evaluate intravascular ultrasound (IVUS) imaging as a tool for grading the presence and characterization of intravascular lead adherence (ILA, or scarring) to cardiovascular…
- Conditions
- Device Malfunction, ICD, Pacemaker Lead Dysfunction
- Trial name
- ISEE (NCT04055740)
- Testing
- IVUS Imaging
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Chicago
Mechanical Complication of Cardiac Electronic Device
Multicenter Imaging in Lead Extraction Study
The primary objectives of this registry is to correlate the amount of fibrosis as documented on Electrocardiogram (ECG) gated Computed Tomography (CT) scans with ease of advancing sheaths over the leads through the SVC zone…
- Trial name
- MILES (NCT03772704)
- Where
- 5 sites in United States, Germany
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- The Cleveland Clinic
Smoking Cessation, Smokeless Tobacco
In-vivo Extraction of Pb, Cd andTSNA From Swedish Snus
In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini".
- Conditions
- Smoking Cessation, Smokeless Tobacco, Harm Reduction
- Trial name
- SMWS03 (NCT01249339)
- Testing
- Buccal Administration of nicotine
- Where
- Sweden
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Contract Research Organization el AB
Myopia
Lower Femtosecond Laser Energy Levels Lead to Better Visual Recovery After Small-incision Lenticule Extraction for Myopia
Small-incision lenticule extraction (SMILE), the most recently developed refractive surgical technique, is being performed in a growing number of cases.
- Trial name
- NCT03111160
- Testing
- SMILE procedure using lower energy (100, 105, and 110 nJ), SMILE procedure using conventional energy (115 to 150 nJ)
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- Yonsei University
Ventricular Tachycardia, Arrythmia
Rook Epicardial Access Device Study
The purpose of this study is to confirm the efficacy and safety of the Talon Surgical Rook® Epicardial Access Kit as a pericardial access device.
- Trial name
- NCT03427333
- Testing
- The Rook® Epicardial Access Kit
- Where
- Czechia
- Volunteers
- 13 people
- Sponsor
- Talon Surgical
Pacemaker Lead Dysfunction, Pacemaker Electrode Infection
Contemporary Transvenous Lead Extraction Outcomes
Presentation of procedural safety and outcomes data from a high volume TLE centre
- Conditions
- Pacemaker Lead Dysfunction, Pacemaker Electrode Infection, ICD, Endocarditis Infective
- Trial name
- TLE (NCT05037474)
- Testing
- TLE group
- Where
- Germany
- Volunteers
- 340 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Pacemaker Lead Dysfunction, Manual Traction
Lead Extraction With Manual Traction
The number of implantable cardiac rhythm devices is increasing. As a result, the number of patients requiring lead extraction is increasing.
- Trial name
- NCT07023900
- Testing
- Manual traction
- Volunteers
- 130 people
- Sponsor
- Bursa Postgraduate Hospital
Smoking Cessation, Harm Reduction
In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Swedish 'Snus' in Regular Snus Users
In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini".
- Trial name
- SMWS03 (NCT01838473)
- Testing
- Buccal Administration of nicotine
- Where
- Sweden
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Contract Research Organization el AB
C.Surgical Procedure; Cardiac, Cardiac Dysrhythmia
Bridge Occlusion Balloon in Lead Extraction Procedure
To evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within the Superior Vena Cava in lead extraction patients.
- Conditions
- C.Surgical Procedure; Cardiac, Cardiac Dysrhythmia, Disorder of Pacing Function
- Trial name
- NCT02714153
- Testing
- Bridge Balloon
- Where
- 7 sites in United States
- Volunteers
- 23 people
- Sponsor
- Yale University
Heart Failure, Indications for Lead Removal
Attain StarFix® 4195 Lead Extraction Study
The purpose of this study is to characterize the removability of the Attain StarFix® Model 4195 Left Ventricular (LV) Lead (StarFix®).
- Trial name
- NCT00893386
- Testing
- LV Lead Extraction
- Where
- 24 sites in United States, Canada
- Volunteers
- 227 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Arrhythmia, Cardiac
Japanese Lead Extraction Registry
Japanese Lead Extraction (J-LEX) Registry is an observational nationwide registry, performed by Japanese Heart Rhythm Society, collaborated with the National Cerebral and Cardiovascular Center.
- Trial name
- J-LEX (NCT04345627)
- Where
- Japan
- Volunteers
- 5,000 people
- Sponsor
- National Cerebral and Cardiovascular Center, Japan
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
Pacemaker Lead Dysfunction
Complications of a Stepwise Approach for Transvenous Lead Extraction
It is an observational study of predictors of complications and difficulty of trans-venous lead extraction procedure. This procedure is done for patient who had a previous cardiac pacemaker or defibrillator implantation which had…
- Trial name
- NCT04306575
- Testing
- Trans-venous lead extraction
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Assiut University
Implant Site Infection
Safety and Performance of LeadExx LC System in Lead Extraction
The study's main purpose is to evaluate the safety and performance of the LeadExx LC System and its ability to safely extract leads. The study will enroll 10 patients scheduled for CIED lead extraction.
- Trial name
- NCT02996929
- Testing
- LC System
- Volunteers
- 10 people
- Sponsor
- LeadExx Cardiac Ltd.