Status:
COMPLETED
Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device
Lead Sponsor:
Guidant Corporation
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Systolic Heart Failure
Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This prospective, randomized, single blind, multi-centre study will examine the effect of the right ventricular (RV) lead location in patients implanted with a cardiac resynchronization defibrillator....
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Accepted CRT indication according to ESC with
- Documented LVEF \</= 35% in last 3 months
- Documented LVEDD ≥ 55 mm or LVEDD \> 30 mm/m2, or LVEDD \>30 mm/m (height) in last 3 months
- QRS ≥120 ms documented on ECG recording during hospitalisation
- 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).
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
263 Patients enrolled
Trial Details
Trial ID
NCT00833352
Start Date
November 1 2008
End Date
December 1 2011
Last Update
January 30 2014
Active Locations (26)
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1
Centre Hospitalier Universitaire d'Angers
Angers, France, 49033
2
Hôpital Louis Pradel
Bron, France, 69677
3
Centre Hospitalier Universitaire de Grenoble- Hôpital Albert Michalon
Grenoble, France, 38043
4
Centre Hospitalier Régional Universitaire de Lille
Lille, France, 59037