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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 distance

peak 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

Page last updated: August 23, 2015

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