Coronary Disease Clinical Trial
Official title:
Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients
During percutaneous cardiovascular intervention, temporary cardiac stimulation may be required. Usually this stimulation is generated via a temporary pacing catheter. In order to reduce the complexity of the procedure, a new stimulation strategy has been developed: the "Direct Wire Pacing technique".In this approach, the cardiac stimulation is provided via the guidewire connected to an external pacemaker. Previous study demonstrated the superiority of the new technique compared to the former. However this technique is likely to generate electrical pain, risk of bleeding for the patient and risk of blood exposure accident for the operators. This is why the medical device ELECTRODUCER SLEEVE has been developed. This device integrates a pacing function to the introducer and the guidewire used. The "Direct Wire Pacing technique" is simplified, secured and more reproducible.
During percutaneous cardiovascular interventions such as Transcatheter Heart Valve or coronary intervention, temporary cardiac stimulation may be required. Usually this stimulation is generated via a temporary pacing catheter in the right ventricle. This procedure requires an additional venous access and the insertion of the stimulation catheter, which are both likely to generate complications. In order to reduce the complexity and increase the safety of the procedure, a new stimulation strategy has been developed: the "Direct Wire Pacing technique". In this approach, the specific venous access and the implantation of a stimulation catheter are avoided. The cardiac stimulation is provided via the guidewire inserted into the left ventricle or into the coronary arteries. This guidewire is connected to an external Pacemaker using an alligator clamp (Cathode). The Pacemaker anode is also connected using a clamp attached to a needle piercing the subcutaneous tissue, obtaining a closed electrical circuit. This technique was validated during previous studies in the TAVI context through two registries and one randomized controlled trial. This study demonstrated the superiority of the new technique by showing a reduction of the procedural duration, radiation exposure and costs; with similar efficacy and safety. However the subcutaneous needle insertion is likely to generate electrical pain, risk of bleeding for the patient and risk of blood exposure accident for the operators. This subcutaneous anode increases the stimulation threshold (mA) which can cause stimulation failures. Moreover, several technical difficulties preclude general adoption by the scientific community. This is why the medical device ELECTRODUCER SLEEVE has been developed. This device integrates a pacing function to the introducer and the guidewire used during percutaneous cardiovascular interventions. The guidewire then behaves like an intra-cardiac cathode. Thanks to the device, the complex manipulation of needles and clamps during the intervention are avoided as well as pole inversions. The "Direct Wire Pacing technique" used during the coronary and structural interventions is thus simplified, secured and more reproducible. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Completed |
NCT05672862 -
International Post-PCI FFR Extended Registry
|
||
Completed |
NCT04492423 -
VerifyNow® PRUTest® Cardiovascular Population Expected Values On-Drug Study
|
||
Completed |
NCT01205776 -
EXCEL Clinical Trial
|
N/A | |
Recruiting |
NCT01218776 -
International Survey of Acute Coronary Syndromes in Transitional Countries
|
||
Completed |
NCT00046410 -
Comparison of the Risk of Stroke With On- Versus Off-Pump Coronary Artery Bypass Grafting
|
N/A | |
Recruiting |
NCT04390672 -
Multivessel TALENT
|
N/A | |
Not yet recruiting |
NCT02895009 -
Hemostatic Compression Patterns After Transradial Coronary Intervention
|
N/A | |
Completed |
NCT02784873 -
High Intensity Interval Training in UK Cardiac Rehabilitation Programmes
|
N/A | |
Completed |
NCT02948517 -
Time Restricted Feeding for Weight Loss and Cardio-protection
|
N/A | |
Recruiting |
NCT02859480 -
Dose-dependent Effect of Rosuvastatin on Long-term Clinical Outcomes After PCI
|
Phase 4 | |
Completed |
NCT02382731 -
Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction
|
N/A | |
Withdrawn |
NCT02418143 -
A Study to Obtain Additional Information on the Use of CorMatrix® CanGaroo ECM® Envelope
|
||
Completed |
NCT02510547 -
Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial
|
Phase 4 | |
Recruiting |
NCT01681381 -
Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization
|
N/A | |
Completed |
NCT02248415 -
Administration of Warm Blood Cardioplegia With or Without Roller Pump
|
N/A | |
Recruiting |
NCT01207167 -
Mediators of Atherosclerosis in South Asians Living in America
|
||
Completed |
NCT02088138 -
Functional Electrical Stimulation in Cardiac Patients
|
N/A | |
Completed |
NCT02133807 -
Specific Lp(a) Apheresis for Regression of Coronary and Carotid Atherosclerosis
|
Phase 3 | |
Completed |
NCT02173067 -
Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective
|
N/A |