Clinical trials: Electrode Malfunction
Sudden Cardiac Death, Implantable Defibrillator
SCREENING FOR THE IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE AUTOMATIC DEFIBRILLATOR
S-ICD (subcutaneous implantable cardioverter-defibrillator) screening failure occurs in about 10% of cases. Predictors of screening failure are not yet well determined.
- Trial name
- SIS (NCT04101253)
- Testing
- new screening procedure with small variations in electrode positioning
- Where
- 16 sites in France
- Volunteers
- 480 people
- Sponsor
- Centre Hospitalier de PAU
ICD Malfunction, Sudden Cardiac Death
S-ICD Electrode Registry
The subcutaneous implantable cardioverter defibrillator (S-ICD) is established in the prevention of sudden cardiac death, but recently a defect of the electrode's Sense-B component was reported in some patients.
- Trial name
- NCT05713708
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- Universitätsklinikum Köln
Congestive Heart Failure
Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead
- Trial name
- NCT00158938
- Testing
- EASYTRAK 3 left ventricular pacing lead
- Volunteers
- 115 people
- Sponsor
- Boston Scientific Corporation
Heart Failure Acute, Heart Failure
Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects
A single-arm study to observe NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System hemodynamic and other physiologic effects.
- Trial name
- COAST-HF FX (NCT03542123)
- Testing
- NeuroTronik CANS Therapy® System
- Where
- Paraguay
- Volunteers
- 30 people
- Sponsor
- NeuroTronik Inc.
Heart Failure Acute
Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF)
A feasibility study to investigate the safety and performance of the NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System
- Trial name
- NCT03169803
- Testing
- NeuroTronik CANS Therapy™ System
- Where
- Panama
- Volunteers
- 40 people
- Sponsor
- NeuroTronik Inc.
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
Bradycardia, Congestive Heart Failure
The EASYTRAK EPI Clinical Investigation
The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.
- Trial name
- EASYTRAK EPI (NCT00158925)
- Testing
- EASYTRAK EPI lead
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Dysrhythmia, Cardiac, Heart Failure
Video Assisted Pericardioscopic Surgery: Minimal-invasive Implantation of Epimyocardial Pacemaker Leads in Humans
Particularly in CRT (Cardiac Resynchronisation Therapy), limited accessibility of the coronary sinus along with its branches and the mismatch between the region of latest left ventricular (LV) contraction and an adequate…
- Conditions
- Dysrhythmia, Cardiac, Heart Failure, Pacemaker Electrode Infection, Hemodialysis-Induced Symptom
- Trial name
- VAPS (NCT03387488)
- Testing
- StingrayTM, Medtronic®
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- RWTH Aachen University
Heart Failure
ELECTION - The Electrode Configuration Cardiac Resynchronization Therapy (CRT) Study (ELECTION)
The ELECtrode configuraTION CRT Study (ELECTION)
- Trial name
- ELECTION (NCT00848653)
- Testing
- CRT device
- Volunteers
- 260 people
- Sponsor
- Guidant Corporation
Heart Failure, Ventricular Dysfunction
Safety and Performance of Electrodes Implanted in the Left Ventricle
The study is intended to demonstrate the safe implant of small receiver-electrodes into the endocardial surface of the left ventricle and to demonstrate its utility in providing cardiac resynchronization therapy in heart failure…
- Conditions
- Heart Failure, Ventricular Dysfunction, Cardiomyopathies, Heart Diseases
- Trial name
- SELECT-LV (NCT01905670)
- Testing
- WiCS-LV system
- Where
- 2 sites in Czechia, Denmark
- Volunteers
- 39 people
- Sponsor
- EBR Systems, Inc.