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

Italy164 participantsStarted 2013-09

Plain-language 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 ) .

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with standard indications to stimulation with a high probability of paced beats according to the clinical evaluation of the investigators: * First degree AV block (PR ≥ 220 ms) and indication for pacing * Paroxysmal AV block second degree (Type I and Type II) associated with long-PR (PR ≥ 220 ms) * Patient must be able to attend all required follow-up visits at the study center. * LVEF\> 35% Exclusion Criteria : * Patient is less than 18 years of age. * Patients with a life expectancy less than 12 months * Indication for CRT in class I and II * Third-degree AV block * Patients currently enrolled in other studies / logs * Patients who are not able to understand and sign an informed consent * State of current or planned pregnancy within 12 months of enrollment * Inability to understand and complete the questionnaire QOL

What they're measuring

LVEF

Timeframe: 2 years

LVESV

Timeframe: 2 years

Trial details

NCT IDNCT02150538

SponsorGianluca Botto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12