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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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
Sponsor: Gianluca Botto

Current Primary Outcome:

• LVEF [ Time Frame: 2 years ]
  LVEF (Left Ventricular Ejection Fraction: such as the assessment of systolic function of the left ventricle)
• LVESV [ Time Frame: 2 years ]
  LVESV (Left Ventricular End Systolic Volume: such as the assessment of left ventricular remodeling)

Original Primary Outcome: Same as current

Current Secondary Outcome:

• echocardiographic left ventricular measures [ Time Frame: 2 years ]

  . Structure and cardiac function:

  • Left ventricular End Systolic Diameter, Left ventricular End Diastolic Diameter
  • Left Ventricular End Systolic
• Echocardiographic altrial measures [ Time Frame: 2 years ]
  Size of the left atrium (diameter and volume)
• Clinical outcome [ Time Frame: 2 years ]

  Clinical benefit:

  • 6 minute walking test
  • quality of life questionnaire
  • New York Heart Association class
  • number and duration of hospitalizations
• Atrial fibrillation (AF) [ Time Frame: 2 years ]

  Incidence of AF:

  • incidence of persistent AF
  • burden of FA
  • new onset of AF

Original Secondary Outcome: Same as current

Information By: S. Anna Hospital

Dates:
Date Received: April 15, 2014
Date Started: September 2013
Date Completion: December 2016
Last Updated: April 20, 2016
Last Verified: April 2016