Cardiac Resynchronization in Atrial Fibrillation Trial - a Pilot Study
Information source: Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation; Heart Failure
Intervention: Amiodarone (Drug); External electrical cardioversion (EEC) (Procedure); Pharmacotherapy to slow and control ventricular rate (Drug); Atrioventricular junction ablation (AVJA) (Procedure)
Phase: Phase 4
Status: Recruiting
Sponsored by: Institute of Cardiology, Warsaw, Poland Official(s) and/or principal investigator(s): Jan B Ciszewski, MD, Principal Investigator, Affiliation: Institute of Cardiology, Warsaw, Poland Maciej Sterlinski, MD, PhD, Study Chair, Affiliation: Institute of Cardiology, Warsaw, Poland
Overall contact: Jan B Ciszewski, MD, Phone: 223434050, Ext: +48, Email: jciszewski@ikard.pl
Summary
The purpose of this prospective randomized study is to determine whether patients on cardiac
resynchronization therapy with concomitant long-standing persistent or permanent atrial
fibrillation would benefit from a strategy to restore and maintain sinus rhythm (rhythm
control strategy) in comparison to a rate control strategy in terms of higher biventricular
paced beats percentage.
Clinical Details
Official title: Comparison of a Rhythm Control Treatment Strategy Versus a Rate Control Strategy in Patients With Permanent or Long-term Persistent Atrial Fibrillation and Heart Failure Treated With Cardiac Resynchronization Therapy - a Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: BiVp%
Secondary outcome: 6MWT distancepeak VO2 NYHA class Ejection fraction LVEDD reduction from baseline at 1 year LVEDV reduction from baseline at 1 year LVESD reduction from baseline at 1 year LVESV reduction froma baseline at 1 year Reduction of LA diameter at 1 year Reduction of mitral regurgitation at 1 year Heart failure exacerbations Mortality Stroke/TIA CV mortality Cardiovascular hospitalizations Quality of Life AF prevalence Ventricular arrhythmia Electrotherapy Side effects 6MWT distance peak VO2 NYHA class Ejection fraction LVEDD reduction LVEDV reduction Reduction of LA area Reduction of LA diameter Reduction of mitral regurgitation Stroke/TIA Quality of Life BiVp% AF prevalence Electrotherapy Ventricular arrhythmia Side effects Reduction of LA area
Detailed description:
Due to a lack of sufficient data the present guidelines on treatment of patients with atrial
fibrillation (AF) and cardiac resynchronization therapy (CRT) devices are of low scientific
evidence. The efficacy of CRT in AF patients is limited by the percentage of the effective
biventricular paced beats (BiVp%), which should exceed 95%-98% - a goal which is seldom
obtained by means of pharmacological rate control strategy. The only treatment strategy
which effect is scientifically established is an atrioventricular junction ablation (AVJA)
but the use of this method is limited.
On the other hand, about 10% of patients with persistent forms of AF experience a
spontaneous sinus rhythm (SR) resumption after CRT implantation. Moreover, SR resumption and
it's maintenance by means of single external electrical cardioversion in AF patients has
been proven feasible. A strategy of rhythm control in AF patients on CRT could provide high
BiVp% and improve the efficacy of CRT in this group of patients.
To show superiority of the rhythm control strategy over the rate control strategy a sample
size of 60 patients was calculated based on following assumptions: two-tailed test, a type I
error of 0. 05, a power of 80%, efficacy (mean BiVp%) of rate control strategy 90%, efficacy
(mean BiVp%)of rhythm control strategy 98% and 8% drop-out rate to fulfill the criteria of
intention-to-treat analysis. Due to presumed lack of statistical power the secondary end
points and safety endpoints will be considered exploratory.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Permanent or long-standing persistent atrial fibrillation (definitions according to
the latest European Society of Cardiology guidelines on AF)
- At least 3 months after a procedure of a CRT device implantation
- A CRT device with a presence of a right atrial electrode
- Age: ≥18 years old
- Effectively biventricular paced captured beats <95%
- Effective therapy with oral anticoagulants for at least 3 months
- Written informed consent
Exclusion Criteria:
- Reversible causes of AF
- Significant valve disease
- Advanced A-V block (including: AVJA)
- Contraindications to amiodarone (hyperthyroidism, not compensated hypothyroidism,
drug intolerance, QT>460ms for men, QT>450 for women)
- Long-QT syndrome
- Decompensation of the heart failure within 48 hours before the qualification
- Cardiac transplantation in 6 months
- Life expectancy less than 1 year
- Chronic dialysis
- LA diameter >6cm
- Alcohol abuse
- Pregnancy/lack of effective contraceptive therapy (in case of females in the
reproductive age)
- Participation in other clinical trial
Locations and Contacts
Jan B Ciszewski, MD, Phone: 223434050, Ext: +48, Email: jciszewski@ikard.pl
Institute of Cardiology, II Dept. of Coronary Heart Disease, Warsaw 02-637, Poland; Recruiting Jan B Ciszewski, MD, Phone: 223434050, Ext: +48, Email: jciszewski@ikard.pl Jan B Ciszewski, MD, Principal Investigator
Additional Information
Starting date: October 2013
Last updated: March 9, 2015
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