Study to Characterize Atrial Fibrillation in CHF Patients Indicated for CRT
NCT ID: NCT00156728
Last Updated: 2008-11-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
172 participants
Study Classification
INTERVENTIONAL
Study Start Date
2003-10-31
Study Completion Date
2005-12-31
Brief Summary
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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
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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
Conditions
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Congestive Heart Failure, Atrial Fibrillation
Keywords
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Pacemaker artificial, congestive heart failure and atrial fibrillation
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SINGLE_GROUP
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
NONE
Interventions
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Vitatron biventricular pacemaker
Intervention Type
DEVICE
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Medtronic BRC
INDUSTRY
Sponsor Role
lead
Principal Investigators
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Bert Albers, Ms Sc PhD
Role: STUDY_DIRECTOR
Medtronic BRC
Christophe Leclercq, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Departement de Cardiologie et Maladies Vasculaires CHU Pontchaillou, Rennes, France
Locations
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Fakultní Nemocnice U Sv. Anny V Brně
Brno, , Czechia
Site Status
Fakultní Nemocnice S Poliklinikou Ostrava
Ostrava-Poruba, , Czechia
Site Status
Institut Klinické A Experimentální Medicíny
Prague, , Czechia
Site Status
Nemocnice Na Homolce
Prague, , Czechia
Site Status
Centre Hospitalier Du Pays D'Aix
Aix-en-Provence, , France
Site Status
Centre Hospitalier Universitaire
Angers, , France
Site Status
Chru - Hôpital Cardiologique
Lille, , France
Site Status
Centre Hospitalier Saint Philibert
Lomme, , France
Site Status
Hôpital Cardiologique Louis Pradel
Lyon, , France
Site Status
Nouvelles Cliniques Nantaises
Nantes, , France
Site Status
Centre Medico-Chirurgical Ambroise Pare
Neuilly-sur-Seine, , France
Site Status
Centre Hospitalier
Pau, , France
Site Status
Hôpital Cardiologique Du Haut-Levêque - Chu
Pessac, , France
Site Status
Hôpital Pontchaillou - CHU
Rennes, , France
Site Status
Centre Chirurgical Du Val D'Or
Saint-Cloud, , France
Site Status
Clinique Pasteur
Toulouse, , France
Site Status
Ospedale Di Careggi
Florence, , Italy
Site Status
Academisch Medisch Centrum
Amsterdam, , Netherlands
Site Status
Deventer Ziekenhuis
Deventer, , Netherlands
Site Status
Tweesteden Ziekenhuis
Tilburg, , Netherlands
Site Status
Klinicki Centar Srbije
Belgrade, , Serbia
Site Status
Slovenský Ústav Srdcových A Cievnych Chorôb
Bratislava, , Slovakia
Site Status
St. Peters Hospital
Chertsey, , United Kingdom
Site Status
Countries
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Serbia and Montenegro
Czechia
France
Italy
Netherlands
Serbia
Slovakia
United Kingdom
References
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Other Identifiers
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CMD 228
Identifier Type: -
Identifier Source: org_study_id