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

Randomized clinical trial of venous access routes for cardiovascular implantable electronic devices at Hospital de Clínicas de Porto Alegre

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6jp2qv
Enrollment
Unknown
Registered
2019-03-28
Start date
2018-12-19
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradiarritmias

Interventions

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 veno
Procedure/surgery
E07.305.250.750
E07.305.250.159
E07.305.250.750.500

Sponsors

Hospital de Clínicas de Porto Alegre
Lead Sponsor
Hospital de Clínicas de Porto Alegre
Collaborator

Eligibility

Age
18 Years to 110 Years

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: Patients presenting clinical conditions that prevent randomization to one of the access routes, namely: central venous thrombosis; patients with previously implanted leads.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- 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 .—

Countries

Brazil

Contacts

Public ContactAna Tagliari

Hospital de Clínicas de Porto Alegre

atagliari@hcpa.edu.br+55-05133598658

Outcome results

None listed

Source: REBEC (via WHO ICTRP)