Atrial FibrillationPhase 4Pilot-CRAfTNCT01850277
Cardiac Resynchronization in Atrial Fibrillation Trial - a Pilot Study
A Phase 4 study testing Amiodarone, External electrical cardioversion (EEC) and Atrioventricular junction ablation (AVJA) in people with Atrial Fibrillation and Heart Failure, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Heart Failure
- What is being tested?
- Amiodarone, External electrical cardioversion (EEC) and Atrioventricular junction ablation (AVJA)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2013to Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Institute of Cardiology, II Dept. of Coronary Heart Disease
Warsaw, 02-637
Jan B Ciszewski, MD, 223434050 ext. +48, jciszewski@ikard.pl
Jan B Ciszewski, MD
About this study
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
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Heart Failure
- Being tested
- Amiodarone, External electrical cardioversion (EEC), Pharmacotherapy to slow and control ventricular rate, Atrioventricular junction ablation (AVJA)
- Keywords
- Atrial fibrillation, Cardiac resynchronization therapy, Heart failure, Rhythm control strategy
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmiodaroneDrug
Also called Cordarone, Amiodaron, Pacerone, Aratac
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.
External electrical cardioversion (EEC)Procedure or surgery
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.
Pharmacotherapy to slow and control ventricular rateDrug
Also called beta-blockers, digitalis, amiodarone
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%
Atrioventricular junction ablation (AVJA)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Pharmacotherapy to slow and control ventricular rate; Procedure: Atrioventricular junction ablation (AVJA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
BiVp%
Percentage of effective biventricular paced beats during 1st year (mean percentage from baseline to the control visit in 12th month) .
Measured: 1 year
Secondary outcomes (37)
6MWT distance
6 minute walk test distance (in meters)measured at 1 year from baseline
Measured: 1 year
peak VO2
Peak oxygen uptake (peak VO2) measured by means of cardiopulmonary exercise test at 1 year from baseline
Measured: 1 year
NYHA class
Heart failure (HF) symptoms escalation measured in New York Heart Association (NYHA) classes at 1 year from baseline
Measured: 1 year
Ejection fraction
Ejection fraction (EF) [%] assessed in ECHO at 1 year from baseline
Measured: 1 year
LVEDD reduction from baseline at 1 year
Change from baseline in left ventricle end-diastolic diameter (LVEDD) in ECHO at 1 year
Measured: baseline and 1 year
LVEDV reduction from baseline at 1 year
Change from baseline in left ventricle end-diastolic volume (LVEDV) in ECHO at 1 year
Measured: baseline and 1 year
LVESD reduction from baseline at 1 year
Change from baseline in left ventricle end-systolic diameter (LVESD) in ECHO at 1 year
Measured: baseline and 1 year
LVESV reduction froma baseline at 1 year
Change from baseline in left ventricle end-systolic volume (LVESV) in ECHO at 1 year
Measured: baseline and 1 year
Reduction of LA diameter at 1 year
Change from baseline in left atrium diameter assessed in ECHO at 1 year
Measured: baseline and 1 year
Reduction of mitral regurgitation at 1 year
Change from baseline in mitral regurgitation measured in ECHO at 1 year
Measured: baseline and 1 year
Heart failure exacerbations
Number of heart failure exacerbations in the treatment arm in 1 year time from baseline
Measured: up to 1 year
Mortality
Numer of deaths assesed in 1 year follow-up
Measured: up to 1 year
Stroke/TIA
Stroke or transient ischemic attack (TIA) during a year follow-up
Measured: up to 1 year
CV mortality
Death due to cardiovascular (CV) causes during a year follow-up
Measured: up to 1 year
Cardiovascular hospitalizations
Number of hospitalizations due to cardiovascular causes during a year follow-up
Measured: up to 1 year
Quality of Life
The quality of life measured with the Minnesota Living with Heart Failure Questionaire (MLHFQ) at 1 year from baseline
Measured: 1 year
AF prevalence
Measurement of the prevalence of atrial fibrillation (precentage of participants with AF) at 1 year from baseline
Measured: 1 year
Ventricular arrhythmia
Number of ventricular arrhythmias (VF/"Torsade de Pointes" VT/sVT/nsVT) during the first year from basline
Measured: up to 1 year
Electrotherapy
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 the first year from baseline
Measured: up to 1 year
Side effects
Overall number of side effects cases and complications cases of the treatment strategies related to: the device, the pharmacotherapy, the electrotherapy during the first year from baseline.
Measured: 1 year
6MWT distance
6 minute walk test distance (in meters) at 3 months from baseline
Measured: 3 months
peak VO2
Peak oxygen uptake (peak VO2) measured by means of cardiopulmonary exercise test at 3 months from baseline
Measured: 3 months
NYHA class
Heart failure (HF) symptoms escalation measured in New York Heart Association (NYHA) classes at 3 months from baseline
Measured: 3 months
Ejection fraction
Ejection fraction (EF) [%] assessed in ECHO at 3 months from baseline
Measured: 3 months
LVEDD reduction
Change from baseline in left ventricle end-diastolic diameter (LVEDD) reduction in ECHO at 3 months
Measured: baseline and 3 months
LVEDV reduction
Change from baseline in left ventricle end-diastolic volume (LVEDV) reduction in ECHO at 3 months
Measured: baseline and 3 months
Reduction of LA area
Change from baseline in left atrium area assessed in ECHO at 1 year
Measured: baseline and 1 year
Reduction of LA diameter
Change from baseline in left atrium diameter assessed in ECHO at 3 months
Measured: baseline and 3 months
Reduction of mitral regurgitation
Change from baseline in mitral regurgitation measured in ECHO at 3 months
Measured: baseline and 3 months
Stroke/TIA
Stroke or transient ischemic attack (TIA) during the first 3 months from baseline
Measured: up to 3 months
Quality of Life
The quality of life measured with the Minnesota Living with Heart Failure Questionaire (MLHFQ) at 3 months from baseline
Measured: 3 months
BiVp%
Percentage of effective biventricular paced beats during first 3 months from baseline.
Measured: 3 months
AF prevalence
Measurement of the prevalence of atrial fibrillation (precentage of participants with AF) at 3 month from baseline
Measured: 3 months
Electrotherapy
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
Measured: up to 3 months
Ventricular arrhythmia
Number of ventricular arrhythmias (VF/"Torsade de Pointes" VT/sVT/nsVT) during the first 3 months from basline
Measured: up to 3 months
Side effects
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.
Measured: 3 months
Reduction of LA area
Change from baseline in left atrium area assessed in ECHO at 3 months
Measured: baseline and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan B Ciszewski, MD, Principal investigator, National Institute of Cardiology, Warsaw, PolandMaciej Sterlinski, MD, PhD, Study chair, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850277
- Sponsor's protocol ID
- IK-NP-0021-47/1378/13
- Acronym
- Pilot-CRAfT
- Status last verified
- Mar 2015
- First submitted
- 22 Apr 2013
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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. 2026 Apr;115(4):566-575. doi: 10.1007/s00392-024-02541-z. Epub 2024 Oct 10.
PubMed 39387937Ciszewski 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.
PubMed 25281275
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01850277
- Acronym / sponsor ID
- Pilot-CRAfT / IK-NP-0021-47/1378/13
- Conditions
- Atrial Fibrillation, Heart Failure
- Keywords
- Atrial fibrillation, Cardiac resynchronization therapy, Heart failure, Rhythm control strategy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 9 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhythm control | Experimental | Drug: Amiodarone, Procedure: 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 | Active comparator | Drug: Pharmacotherapy to slow and control ventricular rate, Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmiodaroneAlso: Cordarone, Amiodaron, Pacerone, AratacThe 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. | Drug | Rhythm control |
| External electrical cardioversion (EEC)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. | Procedure or surgery | Rhythm control |
| Pharmacotherapy to slow and control ventricular rateAlso: beta-blockers, digitalis, amiodaroneThe 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% | Drug | Rate control |
| Atrioventricular junction ablation (AVJA)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. | Procedure or surgery | Rate control |
Primary outcome
BiVp%
Time frame: 1 year
Percentage of effective biventricular paced beats during 1st year (mean percentage from baseline to the control visit in 12th month) .
37 secondary outcomes
6MWT distance
Time frame: 1 year
peak VO2
Time frame: 1 year
NYHA class
Time frame: 1 year
Ejection fraction
Time frame: 1 year
LVEDD reduction from baseline at 1 year
Time frame: baseline and 1 year
LVEDV reduction from baseline at 1 year
Time frame: baseline and 1 year
LVESD reduction from baseline at 1 year
Time frame: baseline and 1 year
LVESV reduction froma baseline at 1 year
Time frame: baseline and 1 year
Reduction of LA diameter at 1 year
Time frame: baseline and 1 year
Reduction of mitral regurgitation at 1 year
Time frame: baseline and 1 year
Heart failure exacerbations
Time frame: up to 1 year
Mortality
Time frame: up to 1 year
Stroke/TIA
Time frame: up to 1 year
CV mortality
Time frame: up to 1 year
Cardiovascular hospitalizations
Time frame: up to 1 year
Quality of Life
Time frame: 1 year
AF prevalence
Time frame: 1 year
Ventricular arrhythmia
Time frame: up to 1 year
Electrotherapy
Time frame: up to 1 year
Side effects
Time frame: 1 year
6MWT distance
Time frame: 3 months
peak VO2
Time frame: 3 months
NYHA class
Time frame: 3 months
Ejection fraction
Time frame: 3 months
LVEDD reduction
Time frame: baseline and 3 months
LVEDV reduction
Time frame: baseline and 3 months
Reduction of LA area
Time frame: baseline and 1 year
Reduction of LA diameter
Time frame: baseline and 3 months
Reduction of mitral regurgitation
Time frame: baseline and 3 months
Stroke/TIA
Time frame: up to 3 months
Quality of Life
Time frame: 3 months
BiVp%
Time frame: 3 months
AF prevalence
Time frame: 3 months
Electrotherapy
Time frame: up to 3 months
Ventricular arrhythmia
Time frame: up to 3 months
Side effects
Time frame: 3 months
Reduction of LA area
Time frame: baseline and 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Derived from this study: PubMed 39387937Ciszewski 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. 2026 Apr;115(4):566-575. doi: 10.1007/s00392-024-02541-z. Epub 2024 Oct 10.
- Derived from this study: PubMed 25281275Ciszewski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan B Ciszewski, MD principal investigator
National Institute of Cardiology, Warsaw, Poland
Maciej Sterlinski, MD, PhD study chair
National Institute of Cardiology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amiodarone, External electrical cardioversion (EEC) and Atrioventricular junction ablation (AVJA) in people with Atrial Fibrillation and Heart Failure, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan B Ciszewski, MD (223434050 ext. +48, jciszewski@ikard.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BiVp% (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01850277, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.