BiventRicular Pacing in prolongEd Atrio-Ventricular intervaL: the REAL-CRT Study (NCT02150538) | Clinical Trial Compass
UnknownNot Applicable
BiventRicular Pacing in prolongEd Atrio-Ventricular intervaL: the REAL-CRT Study
Italy164 participantsStarted 2013-09
Plain-language 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 ) .
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.