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Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias

NCT01717469 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-11-06

No results posted yet for this study

Summary

Previous experimental and clinical studies have consistently suggested that right ventricular (RV) apical pacing has important adverse effects. Ventricular pacing, however, is required, and cannot be reduced in many patients with atrioventricular block. The SAFE-LVPACE study is a randomized controlled trial that compare the effects of conventional right ventricular (RV) pacing vs. left ventricular (LV) in patients with AV block.

Conditions

Interventions

DEVICE

Left ventricular pacing through coronary sinus tributaries (Attain StarFix)

Left ventricular pacing in patients with bradycardia

DEVICE

Right ventricular pacing (Medtronic)

Conventional right ventricular pacing in patients with bradycardia.

Sponsors & Collaborators

Principal Investigators

  • Roberto Costa, MD PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-06-30
Completion
2017-06-30

Countries

  • Brazil

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01717469 on ClinicalTrials.gov