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

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 ) .

Study Overview

• Status: Unknown
• Conditions: First Degree Atrioventricular Block
• Intervention / Treatment: Device: Dual chamber pacemaker; Device: Cardiac resynchronization therapy pacemaker

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

• Study Type: Interventional
• Enrollment (Anticipated): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Como, Italy, 22100
    • Recruiting
    • Azienda Ospedaliera Sant'Anna
    • Contact: Gianluca Botto; Email: clinical-realcrt@isis.it
    • Principal Investigator: Gianluca Botto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Right ventricular stimulation; patients with conventional Right Ventricular Stimulation (only RV) with optimized algorithms for minimization of pacing	Device: Dual chamber pacemaker; right ventricular stimulation with dual chamber pacemaker
Experimental: Biventricular Stimulation; Patients with biventricular stimulation (Right Ventricle and Left Ventricle)	Device: Cardiac resynchronization therapy pacemaker; biventricular stimulation with cardiac resynchronization therapy pacemaker (crt-p)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
echocardiographic left ventricular measures	. Structure and cardiac function: Left ventricular End Systolic Diameter, Left ventricular End Diastolic Diameter; Left Ventricular End Systolic	2 years
Echocardiographic altrial measures	Size of the left atrium (diameter and volume)	2 years
Clinical outcome	Clinical benefit: 6 minute walking test; quality of life questionnaire; New York Heart Association class; number and duration of hospitalizations	2 years
Atrial fibrillation (AF)	Incidence of AF: incidence of persistent AF; burden of FA; new onset of AF	2 years

Collaborators and Investigators

• Sponsor: Gianluca Botto
• Investigators: Principal Investigator: Gianluca Botto, S. Anna Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: May 26, 2014
• First Posted (Estimate): May 30, 2014

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 20, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Cardiac Resynchronization therapy; Minimized Right ventricular pacing; Prolonged AV conduction
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block; Atrioventricular Block
• Other Study ID Numbers: Parere Unico 86/13