Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device

Launched by GUIDANT CORPORATION · Jan 30, 2009

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Accepted CRT indication according to ESC with
• • 1. Documented LVEF \</= 35% in last 3 months
• • 2. Documented LVEDD ≥ 55 mm or LVEDD \> 30 mm/m2, or LVEDD \>30 mm/m (height) in last 3 months
• • 3. QRS ≥120 ms documented on ECG recording during hospitalisation
• • 4. NYHA Class III or ambulatory class IV stable for the last month previous enrolment
• • Or the previous criteria 1 and 2 and a transient episode in NYHA class III or IV with prior HF hospitalization or intravenous decongestive therapy (IV diuretics, IV neseritide or IV inotropes) in an "out-patient" setting within the year previous enrolment and stabilization to NYHA class II for the last month with a QRS ≥150 ms documented on ECG recording during hospitalisation
• • ICD indication (class I or II A)
• • Optimal and stable medication for at least one month (except for diuretics stable for minimum 1 week) based on ESC guidelines before the enrolment
• • Chronic heart failure (\> 3 months) stable for the last month previous enrolment
• • Stable sinus rhythm at the enrolment
• • Willing and capable of providing informed consent
• • Exclusion Criteria
• • Defibrillation testing not planned during the implant procedure due to a poor haemodynamic or clinical status or other reasons
• • Have persistent atrial fibrillation (AF) or atrial flutter (i.e, can be terminated with medical intervention, but does not terminate spontaneously) within 1 month prior inclusion
• • Documented AF within 1 month prior enrolment
• • Life expectancy \< 12 months or expected to undergo heart transplant within the next 12 months
• • Uncontrolled blood pressure (Systolic BP \> 160 mmHg or Diastolic BP \> 85 mmHg)
• • Hospitalization for HF or intravenous inotropic drug treatment within 1 month prior enrolment
• • Cardiac surgery, per cutaneous transluminal angioplasty (PTCA), myocardial infarction (MI), unstable or severe angina or stroke during last 3 months prior enrolment
• • Previously implanted pacemaker or ICD
• • Uncorrected primary valvular disease
• • Prosthetic tricuspid valve
• • Nursing women or of childbearing potential who are, or might be pregnant at the time of the study
• • Enrolled in any on-going study (including pharmacologic trial).