Congestive Heart Failure, Atrial Fibrillation Clinical Trial
Official title:
Congestive Heart Failure Atrial Arrhythmia Monitoring and Pacing (CHAMP)
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.
| Status | Completed |
| Enrollment | 172 |
| Est. completion date | December 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | Fakultní Nemocnice U Sv. Anny V Brne | Brno | |
| Czech Republic | Fakultní Nemocnice S Poliklinikou Ostrava | Ostrava-Poruba | |
| Czech Republic | Institut Klinické A Experimentální Medicíny | Praha | |
| Czech Republic | Nemocnice Na Homolce | Praha | |
| France | Centre Hospitalier Du Pays D'Aix | Aix-en-Provence | |
| France | Centre Hospitalier Universitaire | Angers | |
| France | Chru - Hôpital Cardiologique | Lille | |
| France | Centre Hospitalier Saint Philibert | Lomme | |
| France | Hôpital Cardiologique Louis Pradel | Lyon | |
| France | Nouvelles Cliniques Nantaises | Nantes | |
| France | Centre Medico-Chirurgical Ambroise Pare | Neuilly-Sur-Seine | |
| France | Centre Hospitalier | Pau | |
| France | Hôpital Cardiologique Du Haut-Levêque - Chu | Pessac | |
| France | Hôpital Pontchaillou - CHU | Rennes | |
| France | Centre Chirurgical Du Val D'Or | Saint-Cloud | |
| France | Clinique Pasteur | Toulouse | |
| Italy | Ospedale Di Careggi | Firenze | |
| Netherlands | Academisch Medisch Centrum | Amsterdam | |
| Netherlands | Deventer Ziekenhuis | Deventer | |
| Netherlands | Tweesteden Ziekenhuis | Tilburg | |
| Serbia | Klinicki Centar Srbije | Belgrade | |
| Slovakia | Slovenský Ústav Srdcových A Cievnych Chorôb | Bratislava | |
| United Kingdom | St. Peters Hospital | Chertsey |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic BRC |
Czech Republic, France, Italy, Netherlands, Serbia, Slovakia, United Kingdom,
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. — View Citation
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. — View Citation
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.
Ansalone G, Giannantoni P, Ricci R, Trambaiolo P, Fedele F, Santini M. Doppler myocardial imaging to evaluate the effectiveness of pacing sites in patients receiving biventricular pacing. J Am Coll Cardiol. 2002 Feb 6;39(3):489-99. — View Citation
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. — View Citation
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
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. — View Citation
Bax JJ, Molhoek SG, van Erven L, Voogd PJ, Somer S, Boersma E, Steendijk P, Schalij MJ, Van der Wall EE. Usefulness of myocardial tissue Doppler echocardiography to evaluate left ventricular dyssynchrony before and after biventricular pacing in patients with idiopathic dilated cardiomyopathy. Am J Cardiol. 2003 Jan 1;91(1):94-7. — View Citation
Bayliss J, Norell M, Canepa-Anson R, Sutton G, Poole-Wilson P. Untreated heart failure: clinical and neuroendocrine effects of introducing diuretics. Br Heart J. 1987 Jan;57(1):17-22. — View Citation
Buxton AE, Lee KL, Fisher JD, Josephson ME, Prystowsky EN, Hafley G. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med. 1999 Dec 16;341(25):1882-90. Erratum in: N Engl J Med 2000 Apr 27;342(17):1300. — View Citation
Carson PE, Johnson GR, Dunkman WB, Fletcher RD, Farrell L, Cohn JN. The influence of atrial fibrillation on prognosis in mild to moderate heart failure. The V-HeFT Studies. The V-HeFT VA Cooperative Studies Group. Circulation. 1993 Jun;87(6 Suppl):VI102-10. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Crijns HJ, Van den Berg MP, Van Gelder IC, Van Veldhuisen DJ. Management of atrial fibrillation in the setting of heart failure. Eur Heart J. 1997 May;18 Suppl C:C45-9. Review. — View Citation
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. — View Citation
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. — View Citation
Digitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med. 1997 Feb 20;336(8):525-33. — View Citation
Dries DL, Exner DV, Gersh BJ, Domanski MJ, Waclawiw MA, Stevenson LW. Atrial fibrillation is associated with an increased risk for mortality and heart failure progression in patients with asymptomatic and symptomatic left ventricular systolic dysfunction: a retrospective analysis of the SOLVD trials. Studies of Left Ventricular Dysfunction. J Am Coll Cardiol. 1998 Sep;32(3):695-703. — View Citation
Effect of enalapril on mortality and the development of heart failure in asymptomatic patients with reduced left ventricular ejection fractions. The SOLVD Investigattors. N Engl J Med. 1992 Sep 3;327(10):685-91. Erratum in: N Engl J Med 1992 Dec 10;327(24):1768. — View Citation
Ehrlich JR, Nattel S, Hohnloser SH. Atrial fibrillation and congestive heart failure: specific considerations at the intersection of two common and important cardiac disease sets. J Cardiovasc Electrophysiol. 2002 Apr;13(4):399-405. Review. — View Citation
Flather MD, Yusuf S, Køber L, Pfeffer M, Hall A, Murray G, Torp-Pedersen C, Ball S, Pogue J, Moyé L, Braunwald E. Long-term ACE-inhibitor therapy in patients with heart failure or left-ventricular dysfunction: a systematic overview of data from individual patients. ACE-Inhibitor Myocardial Infarction Collaborative Group. Lancet. 2000 May 6;355(9215):1575-81. — View Citation
Garrigue S, Jaïs P, Espil G, Labeque JN, Hocini M, Shah DC, Haïssaguerre M, Clementy J. Comparison of chronic biventricular pacing between epicardial and endocardial left ventricular stimulation using Doppler tissue imaging in patients with heart failure. Am J Cardiol. 2001 Oct 15;88(8):858-62. — View Citation
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. — View Citation
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
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. — View Citation
Hohnloser SH, Singh BN. Proarrhythmia with class III antiarrhythmic drugs: definition, electrophysiologic mechanisms, incidence, predisposing factors, and clinical implications. J Cardiovasc Electrophysiol. 1995 Oct;6(10 Pt 2):920-36. Review. — View Citation
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. — View Citation
Køber L, Torp-Pedersen C, Carlsen JE, Bagger H, Eliasen P, Lyngborg K, Videbaek J, Cole DS, Auclert L, Pauly NC. A clinical trial of the angiotensin-converting-enzyme inhibitor trandolapril in patients with left ventricular dysfunction after myocardial infarction. Trandolapril Cardiac Evaluation (TRACE) Study Group. N Engl J Med. 1995 Dec 21;333(25):1670-6. — View Citation
Leclercq C, Walker S, Linde C, Clementy J, Marshall AJ, Ritter P, Djiane P, Mabo P, Levy T, Gadler F, Bailleul C, Daubert JC. Comparative effects of permanent biventricular and right-univentricular pacing in heart failure patients with chronic atrial fibrillation. Eur Heart J. 2002 Nov;23(22):1780-7. — View Citation
Li D, Fareh S, Leung TK, Nattel S. Promotion of atrial fibrillation by heart failure in dogs: atrial remodeling of a different sort. Circulation. 1999 Jul 6;100(1):87-95. — View Citation
Mahoney P, Kimmel S, DeNofrio D, Wahl P, Loh E. Prognostic significance of atrial fibrillation in patients at a tertiary medical center referred for heart transplantation because of severe heart failure. Am J Cardiol. 1999 Jun 1;83(11):1544-7. — View Citation
Middlekauff HR, Stevenson WG, Stevenson LW. Prognostic significance of atrial fibrillation in advanced heart failure. A study of 390 patients. Circulation. 1991 Jul;84(1):40-8. — View Citation
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. — View Citation
Mosterd A, de Bruijne MC, Hoes AW, Deckers JW, Hofman A, Grobbee DE. Usefulness of echocardiography in detecting left ventricular dysfunction in population-based studies (The Rotterdam Study). Am J Cardiol. 1997 Jan 1;79(1):103-4. — View Citation
Opasich C, Tavazzi L, Lucci D, Gorini M, Albanese MC, Cacciatore G, Maggioni AP. Comparison of one-year outcome in women versus men with chronic congestive heart failure. Am J Cardiol. 2000 Aug 1;86(3):353-7. — View Citation
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. — View Citation
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. — View Citation
Pitzalis MV, Iacoviello M, Romito R, Massari F, Rizzon B, Luzzi G, Guida P, Andriani A, Mastropasqua F, Rizzon P. Cardiac resynchronization therapy tailored by echocardiographic evaluation of ventricular asynchrony. J Am Coll Cardiol. 2002 Nov 6;40(9):1615-22. — View Citation
Remme WJ, Swedberg K; Task Force for the Diagnosis and Treatment of Chronic Heart Failure, European Society of Cardiology. Guidelines for the diagnosis and treatment of chronic heart failure. Eur Heart J. 2001 Sep;22(17):1527-60. Erratum in: Eur Heart J 2001 Dec;22(23):2217-8. — View Citation
Rihal CS, Davis KB, Kennedy JW, Gersh BJ. The utility of clinical, electrocardiographic, and roentgenographic variables in the prediction of left ventricular function. Am J Cardiol. 1995 Feb 1;75(4):220-3. — View Citation
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. — View Citation
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. — View Citation
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.
Stellbrink C, Auricchio A, Diem B, Breithardt OA, Kloss M, Schöndube 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. — View Citation
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. — View Citation
van den Berg MP, van Gelder IC, van Veldhuisen DJ. Impact of atrial fibrillation on mortality in patients with chronic heart failure. Eur J Heart Fail. 2002 Oct;4(5):571-5. Review. — View Citation
Walker S, Levy TM, Rex S, Brant S, Allen J, Ilsley CJ, Paul VE. Usefulness of suppression of ventricular arrhythmia by biventricular pacing in severe congestive cardiac failure. Am J Cardiol. 2000 Jul 15;86(2):231-3. — View Citation
Wheeldon NM, MacDonald TM, Flucker CJ, McKendrick AD, McDevitt DG, Struthers AD. Echocardiography in chronic heart failure in the community. Q J Med. 1993 Jan;86(1):17-23. — View Citation
Yu CM, Chau E, Sanderson JE, Fan K, Tang MO, Fung WH, Lin H, Kong SL, Lam YM, Hill MR, Lau CP. Tissue Doppler echocardiographic evidence of reverse remodeling and improved synchronicity by simultaneously delaying regional contraction after biventricular pacing therapy in heart failure. Circulation. 2002 Jan 29;105(4):438-45. — View Citation
* Note: There are 50 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | AF burden at 6 months | No | ||
| Secondary | NYHA class, | No | ||
| Secondary | Ejection Fraction, | No | ||
| Secondary | all cause and sudden death, | No | ||
| Secondary | QRS duration, | No | ||
| Secondary | Left Ventricular End Diastolic Dimension, | No | ||
| Secondary | QT interval and | No | ||
| Secondary | T wave amplitude | No |