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Study to Characterize Atrial Fibrillation in CHF Patients Indicated for CRT
This study has been completed.

First Received on September 8, 2005.   Last Updated on November 3, 2008   History of Changes
Sponsor: Medtronic BRC
Information provided by: Medtronic BRC
ClinicalTrials.gov Identifier: NCT00156728
  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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome
MedlinePlus related topics: Arrhythmia Atrial Fibrillation Heart Failure
U.S. FDA Resources

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
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:
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Dargie HJ. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial. Lancet. 2001 May 5;357(9266):1385-90.
Packer M, Bristow MR, Cohn JN, Colucci WS, Fowler MB, Gilbert EM, Shusterman NH. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med. 1996 May 23;334(21):1349-55.
Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, Palensky J, Wittes J. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med. 1999 Sep 2;341(10):709-17.
Khand AU, Rankin AC, Kaye GC, Cleland JG. Systematic review of the management of atrial fibrillation in patients with heart failure. Eur Heart J. 2000 Apr;21(8):614-32. Review.
[No authors listed] The effect of digoxin on mortality and morbidity in patients with heart failure. The Digitalis Investigation Group. N Engl J Med. 1997 Feb 20;336(8):525-33.
Cazeau S, Ritter P, Lazarus A, Gras D, Backdach H, Mundler O, Mugica J. Multisite pacing for end-stage heart failure: early experience. Pacing Clin Electrophysiol. 1996 Nov;19(11 Pt 2):1748-57.
Auricchio A, Stellbrink C, Block M, Sack S, Vogt J, Bakker P, Klein H, Kramer A, Ding J, Salo R, Tockman B, Pochet T, Spinelli J. Effect of pacing chamber and atrioventricular delay on acute systolic function of paced patients with congestive heart failure. The Pacing Therapies for Congestive Heart Failure Study Group. The Guidant Congestive Heart Failure Research Group. Circulation. 1999 Jun 15;99(23):2993-3001.
Gras D, Mabo P, Tang T, Luttikuis O, Chatoor R, Pedersen AK, Tscheliessnigg HH, Deharo JC, Puglisi A, Silvestre J, Kimber S, Ross H, Ravazzi A, Paul V, Skehan D. Multisite pacing as a supplemental treatment of congestive heart failure: preliminary results of the Medtronic Inc. InSync Study. Pacing Clin Electrophysiol. 1998 Nov;21(11 Pt 2):2249-55.
Stellbrink C, Auricchio A, Diem B, Breithardt OA, Kloss M, Schondube FA, Klein H, Messmer BJ, Hanrath P. Potential benefit of biventricular pacing in patients with congestive heart failure and ventricular tachyarrhythmia. Am J Cardiol. 1999 Mar 11;83(5B):143D-150D.
Saxon LA, Boehmer JP, Hummel J, Kacet S, De Marco T, Naccarelli G, Daoud E. Biventricular pacing in patients with congestive heart failure: two prospective randomized trials. The VIGOR CHF and VENTAK CHF Investigators. Am J Cardiol. 1999 Mar 11;83(5B):120D-123D. Review.
Cazeau S, Ritter P, Bakdach S, Lazarus A, Limousin M, Henao L, Mundler O, Daubert JC, Mugica J. Four chamber pacing in dilated cardiomyopathy. Pacing Clin Electrophysiol. 1994 Nov;17(11 Pt 2):1974-9.
Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53.
Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, Garrigue S, Kappenberger L, Haywood GA, Santini M, Bailleul C, Daubert JC; Multisite Stimulation in Cardiomyopathies (MUSTIC) Study Investigators. Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. N Engl J Med. 2001 Mar 22;344(12):873-80.
Daubert JC, Ritter P, Le Breton H, Gras D, Leclercq C, Lazarus A, Mugica J, Mabo P, Cazeau S. Permanent left ventricular pacing with transvenous leads inserted into the coronary veins. Pacing Clin Electrophysiol. 1998 Jan;21(1 Pt 2):239-45.
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
Achtelik M, Bocchiardo M, Trappe HJ, Gaita F, Lozano I, Niazi I, Gold M, Yong P, Duby C; VENTAK CHF/CONTAK CD Clinical Investigation Study Group. Performance of a new steroid-eluting coronary sinus lead designed for left ventricular pacing. Pacing Clin Electrophysiol. 2000 Nov;23(11 Pt 2):1741-3.
Moss AJ, Hall WJ, Cannom DS, Daubert JP, Higgins SL, Klein H, Levine JH, Saksena S, Waldo AL, Wilber D, Brown MW, Heo M. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med. 1996 Dec 26;335(26):1933-40.
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Salukhe TV, Francis DP, Sutton R. Comparison of medical therapy, pacing and defibrillation in heart failure (COMPANION) trial terminated early; combined biventricular pacemaker-defibrillators reduce all-cause mortality and hospitalization. Int J Cardiol. 2003 Feb;87(2-3):119-20.
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Higgins SL, Yong P, Sheck D, McDaniel M, Bollinger F, Vadecha M, Desai S, Meyer DB. Biventricular pacing diminishes the need for implantable cardioverter defibrillator therapy. Ventak CHF Investigators. J Am Coll Cardiol. 2000 Sep;36(3):824-7.
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[No authors listed] Uniform requirements for manuscripts submitted to biomedical journals. International Committee of Medical Journal Editors. N Engl J Med. 1991 Feb 7;324(6):424-8. No abstract available.
Ansalone G, Giannantoni P, Ricci R, Trambaiolo P, Laurenti A, Fedele F, Santini M. Doppler myocardial imaging in patients with heart failure receiving biventricular pacing treatment. Am Heart J. 2001 Nov;142(5):881-96.
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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 May 21, 2012



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