Cardiac Resynchronization in Atrial Fibrillation Trial - a Pilot Study
- Conditions
- Atrial FibrillationHeart Failure
- Interventions
- Drug: Pharmacotherapy to slow and control ventricular rateProcedure: External electrical cardioversion (EEC)Procedure: Atrioventricular junction ablation (AVJA)
- Registration Number
- NCT01850277
- Lead Sponsor
- National Institute of Cardiology, Warsaw, Poland
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rhythm control External electrical cardioversion (EEC) In this group a strategy to restore and maintain SR, including amiodarone and an external electrical cardioversion (EEC), is implemented. A procedure of AF ablation is possible but not obligatory. At baseline, patients assigned to the group undergo a standard 12-lead ECG, a 6-minute walk test (6MWT), a cardiopulmonary exercise test(CPX), an echocardiography(ECHO), a standard device control; a serum thyroid -stimulating hormone (TSH) level is assessed and patients fill the Minnesota Living With Heart Failure Questionnaire (MLHFQ). Control visits are performed every 3 months including a 12-lead ECG measurement and a device control. On the visits in the 3rd and 12th month an ECHO, a CPX, a 6MWT are performed and a MLHFQ is filled; control TSH levels are assessed every 6 months. Rate control Pharmacotherapy to slow and control ventricular rate In the latter group a pharmacotherapy to slow and control ventricular rate by means of pharmacotherapy and an atrio-ventricular junction ablation (AVJA) is implemented. At baseline, each patient assigned to the rate control group undergoes a standard 12-lead ECG, a 6MWT, a CPX, an ECHO, a standard device control and a serum TSH level assessed. Moreover, the patient fills the Minnesota Living With Heart Failure Questionaire (MLHFQ). The control visits are performed for one year, every 3 months including a standard 12-lead ECG measurement and standard control of the device. On the visits in the 3rd and 12th month additionally an ECHO, a CPX, a 6MWT are performed and a MLHFQ is filled. The control TSH levels are assessed every 6 months. Rate control Atrioventricular junction ablation (AVJA) In the latter group a pharmacotherapy to slow and control ventricular rate by means of pharmacotherapy and an atrio-ventricular junction ablation (AVJA) is implemented. At baseline, each patient assigned to the rate control group undergoes a standard 12-lead ECG, a 6MWT, a CPX, an ECHO, a standard device control and a serum TSH level assessed. Moreover, the patient fills the Minnesota Living With Heart Failure Questionaire (MLHFQ). The control visits are performed for one year, every 3 months including a standard 12-lead ECG measurement and standard control of the device. On the visits in the 3rd and 12th month additionally an ECHO, a CPX, a 6MWT are performed and a MLHFQ is filled. The control TSH levels are assessed every 6 months. Rhythm control Amiodarone In this group a strategy to restore and maintain SR, including amiodarone and an external electrical cardioversion (EEC), is implemented. A procedure of AF ablation is possible but not obligatory. At baseline, patients assigned to the group undergo a standard 12-lead ECG, a 6-minute walk test (6MWT), a cardiopulmonary exercise test(CPX), an echocardiography(ECHO), a standard device control; a serum thyroid -stimulating hormone (TSH) level is assessed and patients fill the Minnesota Living With Heart Failure Questionnaire (MLHFQ). Control visits are performed every 3 months including a 12-lead ECG measurement and a device control. On the visits in the 3rd and 12th month an ECHO, a CPX, a 6MWT are performed and a MLHFQ is filled; control TSH levels are assessed every 6 months.
- Primary Outcome Measures
Name Time Method BiVp% 1 year Percentage of effective biventricular paced beats during 1st year (mean percentage from baseline to the control visit in 12th month) .
- Secondary Outcome Measures
Name Time Method peak VO2 3 months Peak oxygen uptake (peak VO2) measured by means of cardiopulmonary exercise test at 3 months from baseline
NYHA class 3 months Heart failure (HF) symptoms escalation measured in New York Heart Association (NYHA) classes at 3 months from baseline
LVEDV reduction from baseline at 1 year baseline and 1 year Change from baseline in left ventricle end-diastolic volume (LVEDV) in ECHO at 1 year
LVESV reduction froma baseline at 1 year baseline and 1 year Change from baseline in left ventricle end-systolic volume (LVESV) in ECHO at 1 year
Ejection fraction 3 months Ejection fraction (EF) \[%\] assessed in ECHO at 3 months from baseline
LVEDD reduction from baseline at 1 year baseline and 1 year Change from baseline in left ventricle end-diastolic diameter (LVEDD) in ECHO at 1 year
Side effects 3 months Overall number of cases of side effects and complications of the treatment strategies related to: device, pharmacotherapy, electrotherapy during the first 3 months from baseline.
Reduction of mitral regurgitation at 1 year baseline and 1 year Change from baseline in mitral regurgitation measured in ECHO at 1 year
Heart failure exacerbations up to 1 year Number of heart failure exacerbations in the treatment arm in 1 year time from baseline
Ventricular arrhythmia up to 3 months Number of ventricular arrhythmias (VF/"Torsade de Pointes" VT/sVT/nsVT) during the first 3 months from basline
6MWT distance 3 months 6 minute walk test distance (in meters) at 3 months from baseline
LVESD reduction from baseline at 1 year baseline and 1 year Change from baseline in left ventricle end-systolic diameter (LVESD) in ECHO at 1 year
Mortality up to 1 year Numer of deaths assesed in 1 year follow-up
Cardiovascular hospitalizations up to 1 year Number of hospitalizations due to cardiovascular causes during a year follow-up
AF prevalence 3 months Measurement of the prevalence of atrial fibrillation (precentage of participants with AF) at 3 month from baseline
Reduction of LA diameter at 1 year baseline and 1 year Change from baseline in left atrium diameter assessed in ECHO at 1 year
Stroke/TIA up to 3 months Stroke or transient ischemic attack (TIA) during the first 3 months from baseline
CV mortality up to 1 year Death due to cardiovascular (CV) causes during a year follow-up
Quality of Life 3 months The quality of life measured with the Minnesota Living with Heart Failure Questionaire (MLHFQ) at 3 months from baseline
Electrotherapy up to 3 months The number of high-energy interventions ("shocks") including separately: adequate shocks, inadequate shocks, electrical storm applies only to the patients with CRT-D device during first 3 months from baseline
LVEDV reduction baseline and 3 months Change from baseline in left ventricle end-diastolic volume (LVEDV) reduction in ECHO at 3 months
Reduction of LA area baseline and 3 month Change from baseline in left atrium area assessed in ECHO at 3 months
LVEDD reduction baseline and 3 months Change from baseline in left ventricle end-diastolic diameter (LVEDD) reduction in ECHO at 3 months
Reduction of LA diameter baseline and 3 months Change from baseline in left atrium diameter assessed in ECHO at 3 months
Reduction of mitral regurgitation baseline and 3 months Change from baseline in mitral regurgitation measured in ECHO at 3 months
BiVp% 3 months Percentage of effective biventricular paced beats during first 3 months from baseline.
Trial Locations
- Locations (1)
Institute of Cardiology, II Dept. of Coronary Heart Disease
🇵🇱Warsaw, Poland