First Degree Atrioventricular Block Clinical Trial
— REAL-CRTOfficial title:
BiventRicular Pacing in prolongEd Atrio-Ventricular intervaL: the REAL-CRT Study
Verified date | April 2016 |
Source | S. Anna Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
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 ) .
Status | Recruiting |
Enrollment | 164 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera Sant'Anna | Como |
Lead Sponsor | Collaborator |
---|---|
Gianluca Botto |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | LVEF | LVEF (Left Ventricular Ejection Fraction: such as the assessment of systolic function of the left ventricle) | 2 years | No |
Primary | LVESV | LVESV (Left Ventricular End Systolic Volume: such as the assessment of left ventricular remodeling) | 2 years | No |
Secondary | echocardiographic left ventricular measures | . Structure and cardiac function: Left ventricular End Systolic Diameter, Left ventricular End Diastolic Diameter Left Ventricular End Systolic |
2 years | No |
Secondary | Echocardiographic altrial measures | Size of the left atrium (diameter and volume) | 2 years | No |
Secondary | Clinical outcome | Clinical benefit: 6 minute walking test quality of life questionnaire New York Heart Association class number and duration of hospitalizations |
2 years | No |
Secondary | Atrial fibrillation (AF) | Incidence of AF: incidence of persistent AF burden of FA new onset of AF |
2 years | No |