Cardiac Resynchronization in Atrial Fibrillation Trial - a Pilot Study

NCT01850277 | Unknown Phase 4

• 1 other identifier: IK-NP-0021-47/1378/13
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Heart Failure

Keywords

Atrial fibrillation; Cardiac resynchronization therapy; Heart failure; Rhythm control strategy

Outcome Measures

Primary Outcomes (1)

• BiVp%

  Percentage of effective biventricular paced beats during 1st year (mean percentage from baseline to the control visit in 12th month) .

  1 year

Secondary Outcomes (37)

• 6MWT distance

  1 year

• peak VO2

  1 year

• NYHA class

  1 year

• Ejection fraction

  1 year

• LVEDD reduction from baseline at 1 year

  baseline and 1 year

Other Outcomes (1)

• Identification of the factors predicting the response to the rhythm control strategy

  1 year

Study Arms (2)

Rhythm control

EXPERIMENTAL

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.

Drug: Amiodarone; Procedure: External electrical cardioversion (EEC)

Rate control

ACTIVE COMPARATOR

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.

Drug: Pharmacotherapy to slow and control ventricular rate; Procedure: Atrioventricular junction ablation (AVJA)

Interventions

Amiodarone DRUG

The pharmacological treatment in the rhythm control strategy consist of amiodarone given orally including the loading dose up to 600mg daily - for the first 4 weeks. Then, a maintenance dose of 200mg/daily is prescribed. The use of other anti-arrhythmic agents is possible unless they are contraindicated. The introduction of amiodarone must not be performed unless the patient is treated effectively with oral anticoagulants for 3 weeks at least. Discontinuation of amiodarone results neither in withdrawal from the study nor in change of the treatment arm.

Also known as: Cordarone, Amiodaron, Pacerone, Aratac, Cardinorm, Rithmik, Arycor, Atlansil, Tachyra

Rhythm control

External electrical cardioversion (EEC) PROCEDURE

The first EEC is performed after the loading dose of amiodarone has been administered. A maximal number of shocks during one cardioversion is 3. The amount of the energy delivered during shocks is left at discretion of a physician performing the EEC. The EEC must be performed in accordance with the present guidelines on EEC and post-procedural care and the state of art. If atrial fibrillation reoccur, the patient should undergo a next EEC as soon as possible but preserving the safety time margins (i.e. effective anticoagulation period). The maximal no. of EEC procedures is 3. If sinus rhythm resumption or its maintenance is impossible or AF reoccur after the 3rd EEC, a strategy of rhythm control is discontinued and a rate control strategy is implemented.

Rhythm control

Pharmacotherapy to slow and control ventricular rate DRUG

The pharmacotherapy should be consistent with current guidelines. It should include negative chronotropic and negative dromotropic agents such as beta-blockers, digitalis and amiodarone (the use of other, less popular agents, is also possible). The choice of the agents as well as their dosages are left at discretion of the treating physician. The goal of the therapy is to obtain BiVp% \>95%

Also known as: beta-blockers, digitalis, amiodarone

Rate control

Atrioventricular junction ablation (AVJA) PROCEDURE

The procedure of atrioventricular junction ablation is dedicated to the patients in the rate control group in who the rate control is unsatisfactory. An AVJA procedure is not obligatory. The decision to perform an AVJA should be discussed with the patient and should be made collectively by the therapeutic team.

Rate control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead

Study Sites (1)

Institute of Cardiology, II Dept. of Coronary Heart Disease

Warsaw, 02-637, Poland

RECRUITING

Related Publications (2)

• Ciszewski JB, Tajstra M, Kowalik I, Maciag A, Chwyczko T, Jankowska A, Smolis-Bak E, Firek B, Zajac D, Karwowski J, Szwed H, Pytkowski M, Gasior M, Sterlinski M. Rhythm and rate control strategies in patients with long-standing persistent atrial fibrillation treated with cardiac resynchronization: the results of the randomized Pilot-CRAfT study. Clin Res Cardiol. 2024 Oct 10. doi: 10.1007/s00392-024-02541-z. Online ahead of print.

  PMID: 39387937 DERIVED

• Ciszewski J, Maciag A, Kowalik I, Syska P, Lewandowski M, Farkowski MM, Borowiec A, Chwyczko T, Pytkowski M, Szwed H, Sterlinski M. Comparison of the rhythm control treatment strategy versus the rate control strategy in patients with permanent or long-standing persistent atrial fibrillation and heart failure treated with cardiac resynchronization therapy - a pilot study of Cardiac Resynchronization in Atrial Fibrillation Trial (Pilot-CRAfT): study protocol for a randomized controlled trial. Trials. 2014 Oct 4;15:386. doi: 10.1186/1745-6215-15-386.

  PMID: 25281275 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Interventions

Amiodarone; Adrenergic beta-Antagonists

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Jan B Ciszewski, MD

  National Institute of Cardiology, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

• Maciej Sterlinski, MD, PhD

  National Institute of Cardiology, Warsaw, Poland

  STUDY CHAIR

Central Study Contacts

Jan B Ciszewski, MD

CONTACT

223434050; jciszewski@ikard.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: May 9, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: March 10, 2015

Record last verified: 2015-03

Locations

PL (1)