Restoration of Atrioventricular Synchrony Trial

Boston Scientific Corporation0 sites2 target enrollmentJuly 2011

ConditionsFirst Degree AV Block

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: First Degree AV Block
Sponsor: Boston Scientific Corporation
Enrollment: 2
Primary Endpoint: Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures.
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Detailed Description

Same as above.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

January 2012

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

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

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