Study to Characterize Atrial Fibrillation in CHF Patients Indicated for CRT

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00156728
• Date of registration: 08/09/2005
• Prospective Registration: No
• Primary sponsor: Medtronic BRC
• Public title: Study to Characterize Atrial Fibrillation in CHF Patients Indicated for CRT
• Scientific title: Congestive Heart Failure Atrial Arrhythmia Monitoring and Pacing (CHAMP)
• Date of first enrolment: October 2003
• Target sample size: 172
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00156728
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 4

Countries of recruitment

Czech Republic, Former Serbia and Montenegro, France, Italy, Netherlands, Serbia, Slovakia, United Kingdom

Contacts

• Name: Bert Albers, Ms Sc PhD
• Affiliation: Medtronic BRC

• Name: Christophe Leclercq, MD PhD
• Affiliation: Departement de Cardiologie et Maladies Vasculaires CHU Pontchaillou, Rennes, France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Congestive Heart Failure, Atrial Fibrillation

Intervention(s)

Device: Vitatron biventricular pacemaker

Primary Outcome(s)

AF burden at 6 months [Time Frame: No]

Secondary Outcome(s)

T wave amplitude [Time Frame: No]

Ejection Fraction, [Time Frame: No]

all cause and sudden death, [Time Frame: No]

Left Ventricular End Diastolic Dimension, [Time Frame: No]

NYHA class, [Time Frame: No]

QRS duration, [Time Frame: No]

QT interval and [Time Frame: No]

Secondary ID(s)

CMD 228

Source(s) of Monetary Support

Please refer to primary and secondary sponsors