Cardiac Resynchronization in Atrial Fibrillation Trial - a Pilot Study (Pilot-CRAfT)

National Institute of Cardiology, Warsaw, Poland

Status and phase: Unknown; Phase 4

Conditions: Atrial Fibrillation; Heart Failure

Treatments: Procedure: External electrical cardioversion (EEC); Drug: Amiodarone; Procedure: Atrioventricular junction ablation (AVJA); Drug: Pharmacotherapy to slow and control ventricular rate

Study type: Interventional

Funder types: Other

Identifiers

NCT01850277

IK-NP-0021-47/1378/13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Rhythm control

Experimental group

Description:

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.

Treatment:

Procedure: External electrical cardioversion (EEC)

Drug: Amiodarone

Rate control

Active Comparator group

Description:

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.

Treatment:

Drug: Pharmacotherapy to slow and control ventricular rate

Procedure: Atrioventricular junction ablation (AVJA)