Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156728
Status:
COMPLETED
Last Update Posted:
2008-11-04
First Post:
2005-09-08
Brief Title:
Study to Characterize Atrial Fibrillation in CHF Patients Indicated for CRT
Sponsor:
Medtronic BRC
Organization:
Medtronic BRC
Study Overview
Official Title:
Congestive Heart Failure Atrial Arrhythmia Monitoring and Pacing CHAMP
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None