User Manual Part 4

CLINICAL STUDY - DECREASE HF
C-3
• Willing and capable of undergo in g a device im plant a nd pa rticipating in all
testing associa te d w ith this c linical investigation
• Have a life expectancy of more than 180 days, per physician discre tio n
• Age 18 or above, or of legal age to give informed consent specific to state
and national law
Patients were excluded from the investigation if they met any one of the
following exclusion criteria:
• Right bund le branch block morphology (per World Health Organiza tio n
Guidelines), on a 12-lead ECG obtained no more than 90 days prior to
enrollme nt
• Had previous cardiac resynchronizat ion therapy, a previou s coronary
venous lead, or met the general indications for antibradycardia pacing
• Had a neuromuscular, orthopedic, or other non-cardiac condition that
prevented normal, unsupported walking
• Had an atrial tachyarrhythmia that was permanent (i.e., did not terminate
spontaneously and could not be terminated with medical intervention) or
persistent (i.e., could be terminated with medical intervention, but did not
terminate spontaneously) within 180 days prior to enrollment
• Had a hypersensitivity to a 0.7 mg dose of dexamethasone acetate
• Had surgically uncorrected primary valvular heart disease
• Required dialysis at the time of enrollment
• Had chronic obstructive pulmonary disease (COPD), defined as FEV
1
/FVC
<60%
• Had a myocardial infarct, unstable angina, percutaneous coronary
intervention, or coronary artery bypass graft during the 30 days prior to
enrollme nt
• Had hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy
(e.g., amyloidosis, sarcoidosis)
• Had a mechanical tricuspid prosthesis
- DRAFT -