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

NCT ID: NCT02150538

Last Updated: 2016-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-12-31

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 ) .

Detailed Description

Clinical data suggest that biventricular pacing is able to preserve the myocardial performance more effectively than the right ventricular pacing in patients with atrioventricular block and mild systolic dysfunction . In particular, some studies have shown that medical therapy in these patients could be responsible for an increase in the cumulative percentage of chronic pacing over the 40% threshold , the threshold associated with a higher incidence of atrial fibrillation and hospitalization for heart failure and ventricular arrhythmias . In addition , patients with pre-existing left ventricular dysfunction and indication for pacing standards have improved left ventricular systolic function , exercise capacity and quality of life as a result of biventricular pacing as compared with Right ventricular pacing . These results suggest that biventricular pacing is a feasible option for permanent pacing in patients who have normal systolic function of the left ventricle and that this can be altered from the adverse effects of conventional Right ventricular pacing on systolic function of the left ventricle . This reality has prompted physicians to assess the value and role of cardiac resynchronization therapy (CRT ) in patients with prolonged Atrio-Ventricular (AV) conduction . Note the deleterious effects of chronic stimulation of the right ventricle , the optimal pacing mode should always be considered in these patients at the time of implantation . 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 it with the treatment with dual chamber device

Conditions

First Degree Atrioventricular Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Right ventricular stimulation

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

Group Type: ACTIVE_COMPARATOR

Dual chamber pacemaker

Intervention Type: DEVICE

right ventricular stimulation with dual chamber pacemaker

Biventricular Stimulation

Patients with biventricular stimulation (Right Ventricle and Left Ventricle)

Group Type: EXPERIMENTAL

Cardiac resynchronization therapy pacemaker

Intervention Type: DEVICE

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

Interventions

Cardiac resynchronization therapy pacemaker

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

Intervention Type: DEVICE

Dual chamber pacemaker

right ventricular stimulation with dual chamber pacemaker

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gianluca Botto

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Botto

Head of Electrophysiology Unit

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gianluca Botto

Role: PRINCIPAL_INVESTIGATOR

S. Anna Hospital

Locations

Azienda Ospedaliera Sant'Anna

Como, Como, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Gianluca Botto

Role: primary

clinical-realcrt@isis.it

References

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.

Reference Type: DERIVED

PMID: 31722381 (View on PubMed)

Other Identifiers

Parere Unico 86/13

Identifier Type: -

Identifier Source: org_study_id