Study to Characterize Atrial Fibrillation in CHF Patients Indicated for CRT
Study to Characterize Atrial Fibrillation in CHF Patients Indicated for CRT
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.
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 a prevalence of AF ranging from about 10% to 50%, although the type of AF
 observed and investigated in these studies is not always clearly described.

 A number of mechanisms attributed to congestive heart failure may contribute to the
 development of AF Experimental congestive heart failure promotes sustained AF by ionic
 remodeling and increased interstitial fibrosis. In contrast to tachycardia-mediated AF, in
 congestive heart failure no shortening of atrial refractoriness occurs. Atrial tissue stress
 caused by congestive heart failure may also contribute to promotion of AF by inducing
 triggered activity, affecting atrial refractoriness properties or resulting in increased
 tissue mass supporting re-entry [31]. Existence of these mechanisms suggests that treatment
 of congestive heart failure may also influence the development and progression of AF in these
 patients. Conversion of chronic AF has been observed in patients with congestive heart
 failure treated with biventricular pacing Ventricular ionic remodeling likely underlies the
 increased risk for proarrhythmia in heart failure patients exposed to antiarrhythmic drugs,
 prolonging the action potential duration , which therefore should be avoided in patients with
 congestive heart failure.

 The independent prognostic significance of AF in heart failure patients is still not
 completely clear. Results from some recent studies suggest no independent prognostic
 significance of AF in heart failure patients Result from other large studies on congestive
 heart failure suggest an independent prognostic effect of AF in patients with AF and
 congestive heart failure, associated with an increased risk for pump failure death and
 all-cause mortality a significantly reduced 1-year survival and a higher mortality among
 heart failure patients who developed AF A recent review with regard to the mortality in
 studies on congestive heart failure suggests that concomitant AF does not have an additional
 effect on the mortality in patients with severe heart failure, but does increase the
 mortality in the setting of mild-to-moderate heart failure This observation may be attributed
 to the fact that the atrial contribution to left ventricular filling is limited in patients
 with severe diastolic dysfunction, whereas the atrial contribution may still be of
 hemodynamic importance in mild-to-moderate heart failure
Inclusion Criteria:

 -  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 Criteria:

 -  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