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BiventRicular Pacing in prolongEd Atrio-Ventricular intervaL: the REAL-CRT Study

NCT02150538 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2016-04-21

No results posted yet for this study

Summary

This study was designed to evaluate the potential benefits of treatment with biventricular device in patients with normal systolic function , indication for pacing and impaired atrio-ventricular conduction , by comparing the treatment with dual-chamber device . The REAL -CRT study is designed to test the hypothesis that, in patients with atrioventricular block of I degree and standard pacing indications , biventricular pacing is superior to single stimulation of the right ventricle (RV) with optimized algorithms for minimization of pacing , as assessed by echocardiography an endpoint defined in terms of maintenance over time of left ventricular ejection fraction (LVEF ) and left ventricular end-systolic volume ( LVESV ) .

Conditions

  • First Degree Atrioventricular Block

Interventions

DEVICE

Cardiac resynchronization therapy pacemaker

biventricular stimulation with cardiac resynchronization therapy pacemaker (crt-p)

DEVICE

Dual chamber pacemaker

right ventricular stimulation with dual chamber pacemaker

Sponsors & Collaborators

  • Gianluca Botto

    lead OTHER

Principal Investigators

  • Gianluca Botto · S. Anna Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Italy

Study Locations

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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 NCT02150538 on ClinicalTrials.gov