Status:
COMPLETED
Study to Characterize Atrial Fibrillation in CHF Patients Indicated for CRT
Lead Sponsor:
Medtronic BRC
Conditions:
Congestive Heart Failure, Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to characterize atrial arrhythmias in patients indicated for Cardiac Resynchronization Therapy (CRT) and to monitor changes in atrial arrhythmias while CRT is provided.
Detailed Description
The combination of congestive heart failure and atrial fibrillation is a common co morbidity, although the exact prevalence of AF in the heart failure population is still unclear. Recent studies show ...
Eligibility Criteria
Inclusion
- Patient is willing and able to comply with the protocol
- Patient is willing to sign written informed consent
- Patient is expected to remain available for Follow-up visits
- Patient age is 18 years and older
- patient is on a stable medication regimen (including beta blockers) for at least 4 weeks prior to enrollment
- Baseline criteria: patients should meet all of the following criteria, to be determined at the baseline assessment procedure within 4 weeks prior to device implantation: - New York Heart Association functional classification III or IV
- QRS duration \> 130 ms
- Left ventricular ejection fraction \< 35% measured by echocardiography left ventricular end diastolic dimension \> 55 mm measured by echocardiography
Exclusion
- Patients with unstable angina or who have experienced an acute myocardial infarction or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 3 months prior to enrollment or who are candidates for CABG or PTCA
- Patients who have experienced CVA or TIA with permanent disability within 3 months prior to enrollment
- Patient on, or anticipated to require, intravenous inotropic drug therapy
- Patients with severe primary pulmonary disease (such as cor pulmonale)
- Post heart transplant patients and patients on an urgency list for cardiac transplantation
- Supine systolic blood pressure greater than 170 mm
- Patient who are not expected to survive for 8 months of study participation due to other medical conditions
- Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control
- Serum creatinine greater than 250 mol/l
- Untreated hyperthyroidism
- Patients enrolled in any concurrent (drug and/or device) study
- Patients with an existing implantable cardioverter defibrillator (ICD) or indications for an ICD including those patients with sustained VT within the previous month
- Patients with permanent atrial arrhythmias. Permanent atrial arrhythmia is defined as an arrhythmia for which any possible type of cardioversion is not considered or that is recurrent within 24 hours from an attempted cardioversion
- Patients with contraindications for implantation of a cardiac pacing device
- Patients who are already implanted with a cardiac pacing device for purposes other than Cardiac Resynchronization Therapy
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00156728
Start Date
October 1 2003
End Date
December 1 2005
Last Update
November 4 2008
Active Locations (23)
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1
Fakultní Nemocnice U Sv. Anny V Brně
Brno, Czechia, 65691
2
Fakultní Nemocnice S Poliklinikou Ostrava
Ostrava-Poruba, Czechia, 708 52
3
Institut Klinické A Experimentální Medicíny
Prague, Czechia, 140 21
4
Nemocnice Na Homolce
Prague, Czechia, 150 30