Restoration of Atrioventricular Synchrony Trial (RESTORE-AV)

Boston Scientific

Status

Terminated

Conditions

First Degree AV Block

Treatments

Device: Cardiac resynchronization therapy-defibrillator

Study type

Interventional

Funder types

Industry

Identifiers

NCT01275833

RESTORE AV

Details and patient eligibility

About

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.

Full description

Same as above.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 prevents subject from normal unsupported walking for the six minute hall walk test
Have surgically uncorrected primary valvular heart disease
Second or third degree atrioventricular block (AVB)
Permanent or persistent atrial tachyarrhythmia that is refractory to all therapies
Have had cardiac surgery, percutaneous coronary intervention, or myocardial infarction within 3 months of signing consent or who are likely to undergo a cardiac surgery or procedure in the foreseeable future
Enrolled in any concurrent study unless written approval has been obtained from Boston Scientific or The Integra Group
Women who are pregnant or plan to become pregnant