Evaluation of resynchronization therapy for heart failure (EARTH)

Montréal Heart Institute (Canada)0 sites240 target enrollmentSeptember 9, 2005

Overview

No summary available.

Registry

who.int

Start Date

September 9, 2005

End Date

March 1, 2010

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

Montréal Heart Institute (Canada)

•Correct and updated information as of 05/06/2009:
•Patient must answer yes to the following questions:
•1\. Does the patient require an ICD or an ICD replacement?
•2\. Does the patient have a documented left ventricular ejection fraction (LVEF) less than or equal to 35% measured in the previous 6 months (without major concomitant clinical event)?
•3\. Does the patient have a QRS duration of less than 120 ms?
•4\. Is the patient in sinus rhythm?
•5\. Was the six\-minute walk test distance less than 400 meters and limited by heart failure symptoms?
•Initial (incorrect) information at time of registration:
•1\. Diagnosis of asthma verified by primary care MD.
•2\. Aged greater than or equal to 18 years old, either sex

•Amended as of 05/06/2009:
•Point one of the below exclusion criteria has been amended as follows:
•1\. Indication for permanent pacing or with chronotropic insufficiency defined as follows:
•1\.1\. Any condition where the treating physician believes it would not be acceptable for the patient to have his device NOT programmed with the SENSOR at ON
•1\.2\. Second or third degree AV block, either persistent or intermittent block
•1\.3\. Patients with a pacemaker or an ICD who are paced in either chamber (A or V) more than 5% of the time
•Initial information at time of registration:
•1\. Indication for permanent pacing or with chronotropic insufficiency defined as follows:
•1\.1\. Severe sinus bradycardia (resting heart rate less than 50/min)
•1\.2\. Chronotropic insufficiency, defined as a heart rate during the screening 6\-minute walk test that does not increase by more than 10 beats/minute compared to the resting rate