NCT02150538

Brief 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 ) .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

3.3 years

First QC Date

April 15, 2014

Last Update Submit

April 20, 2016

Conditions

First Degree Atrioventricular Block

Keywords

Cardiac Resynchronization therapyMinimized Right ventricular pacingProlonged AV conduction

Outcome Measures

Primary Outcomes (2)

  • LVEF

    LVEF (Left Ventricular Ejection Fraction: such as the assessment of systolic function of the left ventricle)

    2 years

  • LVESV

    LVESV (Left Ventricular End Systolic Volume: such as the assessment of left ventricular remodeling)

    2 years

Secondary Outcomes (4)

  • echocardiographic left ventricular measures

    2 years

  • Echocardiographic altrial measures

    2 years

  • Clinical outcome

    2 years

  • Atrial fibrillation (AF)

    2 years

Study Arms (2)

Right ventricular stimulation

ACTIVE COMPARATOR

patients with conventional Right Ventricular Stimulation (only RV) with optimized algorithms for minimization of pacing

Device: Dual chamber pacemaker

Biventricular Stimulation

EXPERIMENTAL

Patients with biventricular stimulation (Right Ventricle and Left Ventricle)

Device: Cardiac resynchronization therapy pacemaker

Interventions

Cardiac resynchronization therapy pacemakerDEVICE

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

Biventricular Stimulation
Dual chamber pacemakerDEVICE

right ventricular stimulation with dual chamber pacemaker

Right ventricular stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Sant'Anna

Como, Como, 22100, Italy

RECRUITING

Related Publications (1)

  • Botto GL, Iuliano A, Occhetta E, Belotti G, Russo G, Campari M, Valsecchi S, Stabile G. A randomized controlled trial of cardiac resynchronization therapy in patients with prolonged atrioventricular interval: the REAL-CRT pilot study. Europace. 2020 Feb 1;22(2):299-305. doi: 10.1093/europace/euz321.

    PMID: 31722381DERIVED

Study Officials

  • Gianluca Botto

    S. Anna Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Electrophysiology Unit

Study Record Dates

First Submitted

April 15, 2014

First Posted

May 30, 2014

Study Start

September 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 21, 2016

Record last verified: 2016-04

Locations

IT(1)