Effects of Right Ventricular Pacemaker Lead Position Assessed by MRI (NCT01682239) | Clinical Trial Compass
UnknownNot Applicable
Effects of Right Ventricular Pacemaker Lead Position Assessed by MRI
Austria24 participantsStarted 2012-09
Plain-language summary
Chronic right ventricular apical pacing has been associated with negative hemodynamic effects. Clinical outcome of right ventricular pacing can be influenced by multiple factors. An important factor seems to be optimal lead positioning. Data regarding left ventricular function impaired by lead positioning is insufficient. The aim of the present study therefore is to compare right ventricular apical pacing (RVAP) with right ventricular septal pacing (RVSP). Outcome measurements are echocardiographic features, magnetic resonance imaging and clinical outcome.
Who can participate
Age range
18 Years – 90 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 dysrhythmia requiring dual-chamber pacemaker implantation
* planed MRI-pacemaker implantation (Accent MRI System,St. Jude Medical)
* age between 18-90 years
* no absolute pacemaker dependence
* no present heart failure or any significant coronary heart disease (exclusion by anamnesis and echocardiography - LVH \<15mm, LV EF\>50%)
* no previous myocardial infarction or significant coronary artery disease
* life expectancy \> 1 year
* patients willing to participate in follow-up
Exclusion criteria:
* Contraindications for MRI (Brain aneurysm clips, artificial heart valves, artificial joints, vascular stents)
* Any contraindication for surgery
* Absolute pacemaker dependence
* Claustrophobia
* GFR\<30ml/min/1,73m2
* Allergy to contrast agent
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.