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 range18 Years
SexALL
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 LATITUDEĀ® 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 prā¦
What they're measuring
1
Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures.