Randomized study of different veins for implantation of pacemaker, defibrillator and resynchronizer cables at Hospital de Clínicas de Porto Alegre

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2019
INTERVENTION: Cardiac Resynchronization Therapy Devices Defibrillators Pacemaker, Artificial Procedure/surgery Total of 88 participants divided into two 2 groups. Control group: 44 patients with indication of pacemaker, defibrillator or cardiac resynchronizer therapy submitted to the leads implant through venous access through cephalic vein. Intervention Group: 44 patients with indication of pacemaker, defibrillator or cardiac resynchronizer therapy submitted to the leads implant through axillary vein puncture guided by ultrasonography. CONDITION: Bradiarritmias; Tachyarrhythmias; Ventricular fibrillation; Heart failure ; Bradycardia ; Tachycardia ; Heart Failure Bradycardia Heart Failure Tachycardia PRIMARY OUTCOME: Primary outcome; ‐ Intravenous electrode introduction successfully through the axillary or cephalic vein, awarded intraoperatively. In cases randomized to axillary access, success will be defined as the positioning the electrode(s) in the superior vena cava with a maximum of three puncture attempts, with a total duration not exceed 15 minutes.; In cases randomized to cephalic access, success will be defined as positioning the electrode(s) in the superior vena cava in a maximum of 15 minutes, regardless of a guidewire or introducer use. SECONDARY OUTCOME: ‐ First puncture success rate. ; ‐ Time to obtain the venous access, defined as time from the beginning of the procedure to the positioning of the electrode(s) in the superior vena cava. ; ‐ Number of punctures needed to position the electrode(s) in the superior vena cava, in axillary access group. ; ‐ Need to use guide wire and introducer, in cephalic access group. ; ‐ Need for exchange the venous access site. ; ‐ Immediate mechanical complications within 30 days of the procedure: inadvertent arterial puncture, pneumothorax, hemothorax, pocket hematoma, pocket infection, catheter‐related bloodstream infection, electrode displacement, electrode fracture, nerve injury, deep venous thrombosis . INCLUSION CRITERIA: Patients with a pacemaker or defibrillator implant indication (single‐chamber, bicameral or resynchronizer) who agree to participate in the study and sign the informed consent form.
Epistemonikos ID: 72349d301dc899938e595bcf97232e62306ee355
First added on: Aug 24, 2024