AzTrials
AzTrials

Congestive Heart Failure, Atrial FibrillationPhase 4NCT00156728

Study to Characterize Atrial Fibrillation in CHF Patients Indicated for CRT

A Phase 4 study testing Vitatron biventricular pacemaker in people with Congestive Heart Failure, Atrial Fibrillation, run by Medtronic BRC at 23 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Vitatron biventricular pacemaker
Type of treatment
Medical device
How many people
172 participants
Where
23 sitesin 7 countries
Study dates
Oct 2003to Dec 2005
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

23 sites in 7 countries.

23 sites in 7 countries

France12 sites

  • Centre Hospitalier Du Pays D'Aix

    Aix-en-Provence, 13160

  • Centre Hospitalier Universitaire

    Angers, 49033

  • Chru - Hôpital Cardiologique

    Lille, 59037

  • Centre Hospitalier Saint Philibert

    Lomme, 59462

  • Hôpital Cardiologique Louis Pradel

    Lyon, 69394

  • Nouvelles Cliniques Nantaises

    Nantes, 44277

  • Centre Medico-Chirurgical Ambroise Pare

    Neuilly-sur-Seine, 92200

  • Centre Hospitalier

    Pau, 64046

  • Hôpital Cardiologique Du Haut-Levêque - Chu

    Pessac, 33604

  • Hôpital Pontchaillou - CHU

    Rennes, 35033

  • Centre Chirurgical Du Val D'Or

    Saint-Cloud, 92211

  • Clinique Pasteur

    Toulouse, 92211

Other trials in France

Czechia4 sites

  • Fakultní Nemocnice U Sv. Anny V Brně

    Brno, 65691

  • Fakultní Nemocnice S Poliklinikou Ostrava

    Ostrava-Poruba, 708 52

  • Institut Klinické A Experimentální Medicíny

    Prague, 140 21

  • Nemocnice Na Homolce

    Prague, 150 30

Other trials in Czechia

Netherlands3 sites

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Deventer Ziekenhuis

    Deventer, 7451 CM

  • Tweesteden Ziekenhuis

    Tilburg, 5042 AD

Other trials in Netherlands

Italy1 site

  • Ospedale Di Careggi

    Florence, 50134

Other trials in Italy

Serbia1 site

  • Klinicki Centar Srbije

    Belgrade, 11000

Other trials in Serbia

Slovakia1 site

  • Slovenský Ústav Srdcových A Cievnych Chorôb

    Bratislava, 83348

Other trials in Slovakia

United Kingdom1 site

  • St. Peters Hospital

    Chertsey, KT 16 OPZ

Other trials in United Kingdom

About this study

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.

Read the 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

Being tested
Vitatron biventricular pacemaker
Keywords
Pacemaker artificial, congestive heart failure and atrial fibrillation
Medical subject headings
Heart Failure, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitatron biventricular pacemakerDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AF burden at 6 months

Secondary outcomes (7)

  1. NYHA class,

  2. Ejection Fraction,

  3. all cause and sudden death,

  4. QRS duration,

  5. Left Ventricular End Diastolic Dimension,

  6. QT interval and

  7. T wave amplitude

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startOct 2003
  3. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
172 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00156728
Sponsor's protocol ID
CMD 228
Status last verified
Nov 2008
First submitted
8 Sep 2005
Last updated
4 Nov 2008
Results posted
No

Publications

  • 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. doi: 10.1053/euhj.2001.2783. No abstract available.

    PubMed 11492984

  • 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. doi: 10.1016/s0002-9149(96)00691-1.

    PubMed 9024752

  • 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. doi: 10.1016/0002-9149(95)80023-l.

    PubMed 7832126

  • 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.

    PubMed 8438044

  • SOLVD Investigators; Yusuf S, Pitt B, Davis CE, Hood WB Jr, Cohn JN. Effect of enalapril on mortality and the development of heart failure in asymptomatic patients with reduced left ventricular ejection fractions. N Engl J Med. 1992 Sep 3;327(10):685-91. doi: 10.1056/NEJM199209033271003.

    PubMed 1463530

  • Kober 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. doi: 10.1056/NEJM199512213332503.

    PubMed 7477219

  • Flather MD, Yusuf S, Kober L, Pfeffer M, Hall A, Murray G, Torp-Pedersen C, Ball S, Pogue J, Moye 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. doi: 10.1016/s0140-6736(00)02212-1.

    PubMed 10821360

  • 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. doi: 10.1136/hrt.57.1.17.

    PubMed 3541995

  • 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. doi: 10.1016/s0140-6736(00)04560-8.

    PubMed 11356434

  • 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. doi: 10.1056/NEJM199605233342101.

    PubMed 8614419

  • 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. doi: 10.1056/NEJM199909023411001.

    PubMed 10471456

  • 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. doi: 10.1053/euhj.1999.1767.

    PubMed 10731399

  • 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. doi: 10.1056/NEJM199702203360801.

    PubMed 9036306

  • 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. doi: 10.1111/j.1540-8159.1996.tb03218.x.

    PubMed 8945034

  • 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. doi: 10.1161/01.cir.99.23.2993.

    PubMed 10368116

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitatron biventricular pacemaker in people with Congestive Heart Failure, Atrial Fibrillation, run by Medtronic BRC at 23 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France, Czechia, Netherlands, Italy, Serbia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AF burden at 6 months. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00156728, which also lists 50 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in