Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation
| Registry | NCT05101720, acronym ZEROFLUOROAXI |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 280 (Actual) |
| Sponsor | University Hospital of Ferrara (Other) |
| Conditions | Arrhythmias, Cardiac, Venous Puncture, Implantable Defibrillator User, Pacemaker Complication, Vascular Access Complication, Fluoroscopy; Adverse Effect |
| Interventions | Ultrasound Guided Axillary Venous Access, Fluoroscopy-Guided Axillary Venous Access (Procedure) |
| Dates | start 2021-11-01, primary completion 2022-11-30, completion 2022-12-31, first posted 2021-11-01, last updated 2023-02-08 |
| Locations | 1 site in Italy |
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All trials for Arrhythmias, Cardiac All trials for Venous Puncture All trials of Ultrasound Guided Axillary Venous Access All trials of Fluoroscopy-Guided Axillary Venous Access
Single center, randomized trial (1:1 fashion) to asses the safety and the feasibility of the ultrasound guided venous puncture vs standard fluoroscopic technique in patients undergoing pacemaker or implantable cardioverter-defibrillator implantations.
Rationale: axillary, cephalic and subclavian venous accesses are commonly used in pacemaker and implantable cardioverter defibrillator implantations. Axillary puncture and cephalic vein surgical cutdown are both recommended in international guidelines due to low risk of pneumothorax and chronic lead complications. Sometimes cephalic vein is not available. Today axillary puncture is performed under fluoroscopic view and some complications still exist with this venous access as pneumothorax and arterial puncture. Axillary vein direct visualization can be obtained with standard venography or with ultrasound. With direct visualization and puncture of the axillary vein under ultrasound guidance venography with radiocontrast could be avoided. Less radiation exposure for patient and operator and direct visualization of the needle are possible with lower periprocedural complications using ultrasound. Despite the great interest for ultrasound guided axillary puncture up today we have few data on its feasibility. Our hypothesis is that ultrasound guided axillary access is more safe and more feasible than the standard fluoroscopic technique.
We decided to enroll all the patients undergoing standard transvenous pacemaker or cardioverter implantable defibrillator. We randomize the patients with 1:1 fashion to axillary venous access under fluoroscopic guidance or to ultrasound guided axillary venous access.
Obiectives: to asses safety, feasibility of the ultrasound guided venous puncture.
Main Endpoint: composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Ultrasound Guided Axillary Access | Experimental | Procedure: Ultrasound Guided Axillary Venous Access | Direct visualization of axillary vein with ultrasound will be obtained and used as a guidance for venous puncture. |
| Fluoroscopic Guided Axillary Access | Active comparator | Procedure: Fluoroscopy-Guided Axillary Venous Access | Standard technique: using the intersection of the lateral borders of the second and third rib as a radiological landmarks. |
Sex: All, ages: 18 Years to 120 Years
Inclusion Criteria: * Need of a standard transvenous pacemaker or implantable cardioverter defibrillator implantations * Age > 18 years Exclusion Criteria: * Leadless pacemaker or subcutaneous ICD
| Facility | City | Country | Status |
|---|---|---|---|
| Azienda Ospedaliero-Universitaria di Ferrara | Ferrara | Italy |