Study to Characterize Atrial Fibrillation in CHF Patients Indicated for CRT

This study has been completed.
Sponsor:
Information provided by:
Medtronic BRC
ClinicalTrials.gov Identifier:
NCT00156728
First received: September 8, 2005
Last updated: November 3, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Congestive Heart Failure, Atrial Fibrillation
Device: Vitatron biventricular pacemaker
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Congestive Heart Failure Atrial Arrhythmia Monitoring and Pacing (CHAMP)

Resource links provided by NLM:


Further study details as provided by Medtronic BRC:

Primary Outcome Measures:
  • AF burden at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NYHA class, [ Designated as safety issue: No ]
  • Ejection Fraction, [ Designated as safety issue: No ]
  • all cause and sudden death, [ Designated as safety issue: No ]
  • QRS duration, [ Designated as safety issue: No ]
  • Left Ventricular End Diastolic Dimension, [ Designated as safety issue: No ]
  • QT interval and [ Designated as safety issue: No ]
  • T wave amplitude [ Designated as safety issue: No ]

Estimated Enrollment: 172
Study Start Date: October 2003
Study Completion Date: December 2005
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156728

Locations
Czech Republic
Fakultní Nemocnice U Sv. Anny V Brně
Brno, Czech Republic, 65691
Fakultní Nemocnice S Poliklinikou Ostrava
Ostrava-Poruba, Czech Republic, 708 52
Institut Klinické A Experimentální Medicíny
Praha, Czech Republic, 140 21
Nemocnice Na Homolce
Praha, Czech Republic, 150 30
France
Centre Hospitalier Du Pays D'Aix
Aix-en-Provence, France, 13160
Centre Hospitalier Universitaire
Angers, France, 49033
Chru - Hôpital Cardiologique
Lille, France, 59037
Centre Hospitalier Saint Philibert
Lomme, France, 59462
Hôpital Cardiologique Louis Pradel
Lyon, France, 69394
Nouvelles Cliniques Nantaises
Nantes, France, 44277
Centre Medico-Chirurgical Ambroise Pare
Neuilly-Sur-Seine, France, 92200
Centre Hospitalier
Pau, France, 64046
Hôpital Cardiologique Du Haut-Levêque - Chu
Pessac, France, 33604
Hôpital Pontchaillou - CHU
Rennes, France, 35033
Centre Chirurgical Du Val D'Or
Saint-Cloud, France, 92211
Clinique Pasteur
Toulouse, France, 92211
Italy
Ospedale Di Careggi
Firenze, Italy, 50134
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Deventer Ziekenhuis
Deventer, Netherlands, 7451 CM
Tweesteden Ziekenhuis
Tilburg, Netherlands, 5042 AD
Serbia
Klinicki Centar Srbije
Belgrade, Serbia, 11000
Slovakia
Slovenský Ústav Srdcových A Cievnych Chorôb
Bratislava, Slovakia, 83348
United Kingdom
St. Peters Hospital
Chertsey, United Kingdom, KT 16 OPZ
Sponsors and Collaborators
Medtronic BRC
Investigators
Study Director: Bert Albers, Ms Sc PhD Medtronic BRC
Principal Investigator: Christophe Leclercq, MD PhD Departement de Cardiologie et Maladies Vasculaires CHU Pontchaillou, Rennes, France
  More Information

Publications:
Task Force for the Diagnosis and Treatment of Chronic Heart Failure, European Society of Cardiology: W.J. Remme and K. Swedberg. Guidelines for the diagnosis and treatment of chronic heart failure. Eur Heart J 2001; 22:1527-1560
Gurley J, Lamba S, Moulton K, Miller B, Mullin J, Hine D, MIRACLE and InSync III investigators. Does the availability of multiple left heart lead and delivery systems matter for cardiac resynchronization therapy? Eur Heart J 2002; 4:Abstr Suppl: 51
Auricchio A, Sack S, Stellbrink C, Neuzner J, Tockman B, Hoersch W, Klein H. Transvenous left ventricular pacing using a new over the wire coronary venous lead. Pacing Clin Electrophysiol 1999; 22: 717
Adamson PB, St John Sutton MG, Plappert TJ, Abraham WT, Hilpisch KE, Hill MR. Echo-Defined Ventricular Dysynchrony predicts magnitude of response o Cardiac Resynchronization Abstract presented during AHA Scientific Session 2002.
St John Sutton MG, Plappert TJ, Hilpisch KE, Chinchoy E. Baseline Aortic Pre-Ejection Interval (bAPEI) as a predictor of response to Cardiac Resynchronization Therapy (CRT) Abstract presented during AHA Scientific Session 2002.

ClinicalTrials.gov Identifier: NCT00156728     History of Changes
Other Study ID Numbers: CMD 228
Study First Received: September 8, 2005
Last Updated: November 3, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
France: National Consultative Ethics Committee for Health and Life Sciences
United Kingdom: Research Ethics Committee
Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by Medtronic BRC:
Pacemaker artificial, congestive heart failure and atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014