Restoration of Atrioventricular Synchrony Trial (NCT01275833) | Clinical Trial Compass
TerminatedNot Applicable
Restoration of Atrioventricular Synchrony Trial
Stopped: Difficult subject recruitment
2 participantsStarted 2011-07
Plain-language summary
The objective of the trial is to observe the effects of restoring atrioventricular (AV) synchrony in subjects with prolonged PR intervals. This will be assessed both acutely and chronically using echocardiographic and functional measurements.
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:
* Meet current indications for an implantable cardioverter-defibrillator (ICD) implant with:
* QRS width \< 120 msec
* Left ventricular ejection fraction (LVEF) \< 35% (no more than 180 days prior to enrollment)
* NYHA functional class II/III
* Optimal pharmacological heart failure therapy
* PR interval \>/= 230 msec
* Ability to tolerate protocol required programming
* Access to a telephone line compatible with the LATITUDE® Communicator
* Subjects in sinus rhythm at the time of the baseline visit and who are expected to remain in sinus rhythm for the duration of the study
* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and return to the investigational center at the intervals defined by this protocol
Exclusion Criteria:
* Previously placed pacemaker, ICD, or CRT device
* Inability or refusal to sign the Informed Consent Form
* Documented life expectancy of less than 12 months or expected to undergo heart transplant within the next 12 months
* Have tricuspid valve disease or who are likely to receive a mechanical tricuspid valve during the course of the clinical investigation
* Inability or refusal to comply with the follow-up schedule
* Have a neuromuscular, orthopedic, or other noncardiac condition that pr…
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.
What they're measuring
1
Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures.