Atrial FibrillationCONTRA-HFNCT03062241
Ablation of Atrial Fibrillation in Heart Failure Patients
A study testing Cryoablation in people with Atrial Fibrillation and Severe Heart Failure, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The aim of the study is to evaluate the impact of cryoablation of atrial fibrillation in patients with severe chronic heart failure (CHF) on long term outcome of CHF and efficacy (endurance) of the procedure itself. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Severe Heart Failure
- What is being tested?
- Cryoablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 sitePoland
- Study dates
- 23 Jan 2017to 31 Jul 2019
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years ≤ age ≤ 75 years
- optimal pharmacotherapy within the last 3 months
- New York Heart Association (NYHA) II- IV (out-patient) within the last 3 months
- AF paroxysmal, persistent or persistant long-lasting
- at least 1 episode of paroxysmal AF with the duration of ≥ 30 s or AF burden ≥ 10% during 1 month up to 1 year since ICD or CRT-D implantation
- signed informed consent
Who cannot join
- age < 18 years or > 75 years
- permanent AF
- contraindications to oral anticoagulation or heparin
- prior AF ablation
- chronic kidney disease requiring dialysis
- untreated hypo- or hyperthyroidism
Show all 19Show fewer
- breast feeding
- pregnancy
- decompensated heart failure within the last 90 days requiring pressor infusion
- stroke within the last 3 months
- myocardial infarction within the last 3 months
- PCI or CABG within the last 3 months
- active myocarditis
- artificial valve replacement surgery
- severe mitral or aortic stenosis
- coronary artery disease requiring revascularization
- heart transplant
- participation in another study
- comorbidities with expected survival less than 1 year
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Cardiology, Congenital Heart Diseases and Electrotherapy Medical University of Silesia, Silesian Center of Heart Diseases
Zabrze, 41-800
Zbigniew Kalarus, MD, Ph.D., 0048322713414, karzab@sum.edu.pl
About this study
Official title: Cryoablation of Atrial Fibrillation in Patients With Severe Heart Failure
The aim of the study is to evaluate the impact of cryoablation of atrial fibrillation in patients with severe chronic heart failure (CHF) on long term outcome of CHF and efficacy (endurance) of the procedure itself. The study hypothesis is that cryoablation in eligible patients with CHF and ICD/CRT (implantable cardioverter defibrillator / cardiac resynchronization therapy) implants reduce the number of recurrent CHF hospitalizations, mortality, need for mechanical support of LV (left ventricle) and heart transplant (primary endpoint) at 1 year observation in comparison to traditional (pharmacological) treatment..
Read the detailed description
Atrial fibrillation (AF) is one of the most common arrhythmia worldwide and the risk of AF incidence increases with age. The amount of patients suffered from AF is still underestimated due to insufficient diagnosing silent AF. The incidence of patients with silent, asymptomatic AF might be approx. 80% , particularly in patients with heart failure. The most frequent consequence of undiagnosed AF is not only thromboembolism but also heart failure development and loss of quality of life. The incidence of chronic heart failure (CHF), which is the most frequent consequence of coronary heart disease, still increases and nowadays in patients above 70 years affects approx.10%. What is more, AF which is one of the result of CHF occurred in 30% of those patients. Atrial fibrillation ablation is one of the most established method to treat symptomatic patients and its' efficacy is about 70 - 90 %. Hence, the appropriate and effective treatment of those patients might influence not only on the survival but also the quality of life and functionality of health care system.
Among many data about AF in patients with impaired LV (left ventricle) systolic function there is still a lack of randomized, multicenter trials which would compare the influence of AF cryoablation with conventional treatment in patients with LVEF (left ventricle ejection fraction) ≤ 35% (despite optimal pharmacotherapy) on long term survival and efficacy. The deficiency in this field was an inspiration to conduct this study.
- Conditions
- Atrial Fibrillation, Severe Heart Failure
- Being tested
- Cryoablation
- Keywords
- cryoablation, conventional treatment of heart failure
- 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.
CryoablationProcedure or surgery
After left atrial appendage (LAA) thrombus exclusion, the transseptal puncture will be performed and intravenous heparin will be administered to achieve Activated Clotting Time (ACT) ≥300 seconds.The pulmonary vein (PV) isolation will be performed. Optimal cryoballoon positioning will be confirmed by PVs angiography. Pulmonary veins isolation will be confirmed by entrance/exit block using appropriate catheter. During cryoablation of the right PVs, high-output right phrenic nerve stimulation will be performed using a diagnostic catheter placed in the superior vena cava. Whenever decrease/loss of pacing capture will be observed, cryoablation will be immediately terminated.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Experimental | The pulmonary vein (PV) isolation in patients randomized to intervention group. Receives: Procedure: Cryoablation |
| Conventional treatment | No intervention | Pharmacological treatment according to 2016 ESC (European Society of Cardiology) guidelines for the diagnosis and treatment of acute and chronic heart failure and to 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with European Association for Cardio-Thoracic Surgery (EACTS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.
percentage of patients who required intravenous diuretic or pressor administration
Measured: one year
Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.
percentage of patients who died
Measured: one year
Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.
percentage of patients who required mechanical left ventricle support
Measured: one year
Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.
percentage of patients who had a heart transplant
Measured: one year
Secondary outcomes (1)
Percentage of patients who had ischaemic cerebral stroke during 12 months follow up
ischaemic cerebral stroke confirmed in computed tomography
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start23 Jan 2017
- Primary completion31 Jul 2018 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Randomized Controlled Trial (RCT), non-blinded, prospective, multicentre performed in up to 4 cardiology centers in Poland. All patients implanted with a dual-chamber implanted cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) with Home Monitoring capabilities and history of paroxysmal, persistent or persistant long-lasting AF will be screened for the study. In patient who fulfill all inclusion and none of the exclusion criteria 1 year after ICD or CRT-D implantation, with exclusion of 1 month directly after implantation, a device check-up and AF burden will be performer and assessed. Randomization will be performed using sealed envelopes and will be conducted in the coordinating center of the study PI in all patients who sign informed consent and met all inclusions and none of the exclusion criteria. The cryoablation of AF will be performed within 1 month from randomization in the invasive treatment group.
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Collaborators
- Military Institute od Medicine National Research Institute, Clinical Hospital No. 2 Pomeranian Medical University, Szczecin, Poland, Hospital name Pope John Paul, Zamosc, Poland
- Responsible party
- Principal investigator, Zbigniew Kalarus, Medical University of Silesia
- Investigators
- Zbigniew Kalarus, MD, Ph.D., Principal investigator, Department of Cardiology, Congenital Heart Diseases and Electrotherapy Medical University of Silesia, Silesian Center of Heart Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062241
- Sponsor's protocol ID
- CONTRA-HF study
- Acronym
- CONTRA-HF
- Status last verified
- Nov 2017
- First submitted
- 9 Feb 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xiong Q, Proietti M, Senoo K, Lip GY. Asymptomatic versus symptomatic atrial fibrillation: A systematic review of age/gender differences and cardiovascular outcomes. Int J Cardiol. 2015 Jul 15;191:172-7. doi: 10.1016/j.ijcard.2015.05.011. Epub 2015 May 7.
PubMed 25974193Vaidya K, Arnott C, Russell A, Masson P, Sy RW, Patel S. Pulmonary Vein Isolation Compared to Rate Control in Patients with Atrial Fibrillation: A Systematic Review and Meta-analysis. Heart Lung Circ. 2015 Aug;24(8):744-52. doi: 10.1016/j.hlc.2015.02.025. Epub 2015 Mar 14.
PubMed 25890871Lenarczyk R, Jedrzejczyk-Patej E, Szulik M, Mazurek M, Podolecki T, Kowalczyk J, Kowalski O, Sredniawa B, Kalarus Z; Triple-Site Versus Standard Cardiac Resynchronization Trial (TRUST CRT) Investigators. Atrial fibrillation in cardiac resynchronization recipients with and without prior arrhythmic history. How much of arrhythmia is too much? Cardiol J. 2015;22(3):267-75. doi: 10.5603/CJ.a2014.0102. Epub 2015 Jan 7.
PubMed 25563708Marrouche NF, Brachmann J; CASTLE-AF Steering Committee. Catheter ablation versus standard conventional treatment in patients with left ventricular dysfunction and atrial fibrillation (CASTLE-AF) - study design. Pacing Clin Electrophysiol. 2009 Aug;32(8):987-94. doi: 10.1111/j.1540-8159.2009.02428.x.
PubMed 19659616Khan MN, Jais P, Cummings J, Di Biase L, Sanders P, Martin DO, Kautzner J, Hao S, Themistoclakis S, Fanelli R, Potenza D, Massaro R, Wazni O, Schweikert R, Saliba W, Wang P, Al-Ahmad A, Beheiry S, Santarelli P, Starling RC, Dello Russo A, Pelargonio G, Brachmann J, Schibgilla V, Bonso A, Casella M, Raviele A, Haissaguerre M, Natale A; PABA-CHF Investigators. Pulmonary-vein isolation for atrial fibrillation in patients with heart failure. N Engl J Med. 2008 Oct 23;359(17):1778-85. doi: 10.1056/NEJMoa0708234.
PubMed 18946063Zhao L, Xu K, Jiang W, Zhou L, Wang Y, Zhang X, Wu S, Liu X. Long-term outcomes of catheter ablation of atrial fibrillation in dilated cardiomyopathy. Int J Cardiol. 2015;190:227-32. doi: 10.1016/j.ijcard.2015.04.186. Epub 2015 Apr 23.
PubMed 25920033Bunch TJ, May HT, Bair TL, Jacobs V, Crandall BG, Cutler M, Weiss JP, Mallender C, Osborn JS, Anderson JL, Day JD. Five-year outcomes of catheter ablation in patients with atrial fibrillation and left ventricular systolic dysfunction. J Cardiovasc Electrophysiol. 2015 Apr;26(4):363-370. doi: 10.1111/jce.12602. Epub 2015 Feb 11.
PubMed 25534572Rillig A, Makimoto H, Wegner J, Lin T, Heeger C, Lemes C, Fink T, Metzner A, Wissner E, Mathew S, Wohlmuth P, Kuck KH, Tilz RR, Ouyang F. Six-Year Clinical Outcomes After Catheter Ablation of Atrial Fibrillation in Patients With Impaired Left Ventricular Function. J Cardiovasc Electrophysiol. 2015 Nov;26(11):1169-1179. doi: 10.1111/jce.12765. Epub 2015 Sep 3.
PubMed 26217925Schwartzman D, Housel D, Bazaz R, Jain S, Saba S, Gorcsan J 3rd, Adelstein E. A pilot study to assess benefit of atrial rhythm control after cardiac resynchronization therapy and atrioventricular node ablation. Pacing Clin Electrophysiol. 2015 Feb;38(2):275-81. doi: 10.1111/pace.12535. Epub 2014 Nov 27.
PubMed 25431023
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoablation of Atrial Fibrillation in Patients With Severe Heart Failure
- ClinicalTrials.gov ID
- NCT03062241
- Acronym / sponsor ID
- CONTRA-HF / CONTRA-HF study
- Conditions
- Atrial Fibrillation, Severe Heart Failure
- Keywords
- cryoablation, conventional treatment of heart failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Collaborators
- Military Institute od Medicine National Research Institute, Clinical Hospital No. 2 Pomeranian Medical University, Szczecin, Poland, Hospital name Pope John Paul, Zamosc, Poland
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 23 Feb 2017 (actual)
- 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 aim of the study is to evaluate the impact of cryoablation of atrial fibrillation in patients with severe chronic heart failure (CHF) on long term outcome of CHF and efficacy (endurance) of the procedure itself. The study hypothesis is that cryoablation in eligible patients with CHF and ICD/CRT (implantable cardioverter defibrillator / cardiac resynchronization therapy) implants reduce the number of recurrent CHF hospitalizations, mortality, need for mechanical support of LV (left ventricle) and heart transplant (primary endpoint) at 1 year observation in comparison to traditional (pharmacological) treatment..
Detailed description
Atrial fibrillation (AF) is one of the most common arrhythmia worldwide and the risk of AF incidence increases with age. The amount of patients suffered from AF is still underestimated due to insufficient diagnosing silent AF. The incidence of patients with silent, asymptomatic AF might be approx. 80% , particularly in patients with heart failure. The most frequent consequence of undiagnosed AF is not only thromboembolism but also heart failure development and loss of quality of life. The incidence of chronic heart failure (CHF), which is the most frequent consequence of coronary heart disease, still increases and nowadays in patients above 70 years affects approx.10%. What is more, AF which is one of the result of CHF occurred in 30% of those patients. Atrial fibrillation ablation is one of the most established method to treat symptomatic patients and its' efficacy is about 70 - 90 %. Hence, the appropriate and effective treatment of those patients might influence not only on the survival but also the quality of life and functionality of health care system.
Among many data about AF in patients with impaired LV (left ventricle) systolic function there is still a lack of randomized, multicenter trials which would compare the influence of AF cryoablation with conventional treatment in patients with LVEF (left ventricle ejection fraction) ≤ 35% (despite optimal pharmacotherapy) on long term survival and efficacy. The deficiency in this field was an inspiration to conduct this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a Randomized Controlled Trial (RCT), non-blinded, prospective, multicentre performed in up to 4 cardiology centers in Poland. All patients implanted with a dual-chamber implanted cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) with Home Monitoring capabilities and history of paroxysmal, persistent or persistant long-lasting AF will be screened for the study. In patient who fulfill all inclusion and none of the exclusion criteria 1 year after ICD or CRT-D implantation, with exclusion of 1 month directly after implantation, a device check-up and AF burden will be performer and assessed. Randomization will be performed using sealed envelopes and will be conducted in the coordinating center of the study PI in all patients who sign informed consent and met all inclusions and none of the exclusion criteria. The cryoablation of AF will be performed within 1 month from randomization in the invasive treatment group.
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Experimental | Procedure: CryoablationThe pulmonary vein (PV) isolation in patients randomized to intervention group. |
| Conventional treatment | No intervention | –Pharmacological treatment according to 2016 ESC (European Society of Cardiology) guidelines for the diagnosis and treatment of acute and chronic heart failure and to 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with European Association for Cardio-Thoracic Surgery (EACTS). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years ≤ age ≤ 75 years
- optimal pharmacotherapy within the last 3 months
- New York Heart Association (NYHA) II- IV (out-patient) within the last 3 months
- AF paroxysmal, persistent or persistant long-lasting
- at least 1 episode of paroxysmal AF with the duration of ≥ 30 s or AF burden ≥ 10% during 1 month up to 1 year since ICD or CRT-D implantation
Key exclusion criteria (19 listed)
- age < 18 years or > 75 years
- permanent AF
- contraindications to oral anticoagulation or heparin
- prior AF ablation
- chronic kidney disease requiring dialysis
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 |
|---|---|---|
| CryoablationAfter left atrial appendage (LAA) thrombus exclusion, the transseptal puncture will be performed and intravenous heparin will be administered to achieve Activated Clotting Time (ACT) ≥300 seconds.The pulmonary vein (PV) isolation will be performed. Optimal cryoballoon positioning will be confirmed by PVs angiography. Pulmonary veins isolation will be confirmed by entrance/exit block using appropriate catheter. During cryoablation of the right PVs, high-output right phrenic nerve stimulation will be performed using a diagnostic catheter placed in the superior vena cava. Whenever decrease/loss of pacing capture will be observed, cryoablation will be immediately terminated. | Procedure or surgery | Cryoablation |
Primary outcome
Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.
Time frame: one year
percentage of patients who required intravenous diuretic or pressor administration
Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.
Time frame: one year
percentage of patients who died
Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.
Time frame: one year
percentage of patients who required mechanical left ventricle support
Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.
Time frame: one year
percentage of patients who had a heart transplant
1 secondary outcome
Percentage of patients who had ischaemic cerebral stroke during 12 months follow up
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Background: PubMed 25974193Xiong Q, Proietti M, Senoo K, Lip GY. Asymptomatic versus symptomatic atrial fibrillation: A systematic review of age/gender differences and cardiovascular outcomes. Int J Cardiol. 2015 Jul 15;191:172-7. doi: 10.1016/j.ijcard.2015.05.011. Epub 2015 May 7.
- Background: PubMed 25890871Vaidya K, Arnott C, Russell A, Masson P, Sy RW, Patel S. Pulmonary Vein Isolation Compared to Rate Control in Patients with Atrial Fibrillation: A Systematic Review and Meta-analysis. Heart Lung Circ. 2015 Aug;24(8):744-52. doi: 10.1016/j.hlc.2015.02.025. Epub 2015 Mar 14.
- Background: PubMed 25563708Lenarczyk R, Jedrzejczyk-Patej E, Szulik M, Mazurek M, Podolecki T, Kowalczyk J, Kowalski O, Sredniawa B, Kalarus Z; Triple-Site Versus Standard Cardiac Resynchronization Trial (TRUST CRT) Investigators. Atrial fibrillation in cardiac resynchronization recipients with and without prior arrhythmic history. How much of arrhythmia is too much? Cardiol J. 2015;22(3):267-75. doi: 10.5603/CJ.a2014.0102. Epub 2015 Jan 7.
- Background: PubMed 19659616Marrouche NF, Brachmann J; CASTLE-AF Steering Committee. Catheter ablation versus standard conventional treatment in patients with left ventricular dysfunction and atrial fibrillation (CASTLE-AF) - study design. Pacing Clin Electrophysiol. 2009 Aug;32(8):987-94. doi: 10.1111/j.1540-8159.2009.02428.x.
- Results publication: PubMed 18946063Khan MN, Jais P, Cummings J, Di Biase L, Sanders P, Martin DO, Kautzner J, Hao S, Themistoclakis S, Fanelli R, Potenza D, Massaro R, Wazni O, Schweikert R, Saliba W, Wang P, Al-Ahmad A, Beheiry S, Santarelli P, Starling RC, Dello Russo A, Pelargonio G, Brachmann J, Schibgilla V, Bonso A, Casella M, Raviele A, Haissaguerre M, Natale A; PABA-CHF Investigators. Pulmonary-vein isolation for atrial fibrillation in patients with heart failure. N Engl J Med. 2008 Oct 23;359(17):1778-85. doi: 10.1056/NEJMoa0708234.
- Results publication: PubMed 25920033Zhao L, Xu K, Jiang W, Zhou L, Wang Y, Zhang X, Wu S, Liu X. Long-term outcomes of catheter ablation of atrial fibrillation in dilated cardiomyopathy. Int J Cardiol. 2015;190:227-32. doi: 10.1016/j.ijcard.2015.04.186. Epub 2015 Apr 23.
- Results publication: PubMed 25534572Bunch TJ, May HT, Bair TL, Jacobs V, Crandall BG, Cutler M, Weiss JP, Mallender C, Osborn JS, Anderson JL, Day JD. Five-year outcomes of catheter ablation in patients with atrial fibrillation and left ventricular systolic dysfunction. J Cardiovasc Electrophysiol. 2015 Apr;26(4):363-370. doi: 10.1111/jce.12602. Epub 2015 Feb 11.
- Results publication: PubMed 26217925Rillig A, Makimoto H, Wegner J, Lin T, Heeger C, Lemes C, Fink T, Metzner A, Wissner E, Mathew S, Wohlmuth P, Kuck KH, Tilz RR, Ouyang F. Six-Year Clinical Outcomes After Catheter Ablation of Atrial Fibrillation in Patients With Impaired Left Ventricular Function. J Cardiovasc Electrophysiol. 2015 Nov;26(11):1169-1179. doi: 10.1111/jce.12765. Epub 2015 Sep 3.
- Results publication: PubMed 25431023Schwartzman D, Housel D, Bazaz R, Jain S, Saba S, Gorcsan J 3rd, Adelstein E. A pilot study to assess benefit of atrial rhythm control after cardiac resynchronization therapy and atrioventricular node ablation. Pacing Clin Electrophysiol. 2015 Feb;38(2):275-81. doi: 10.1111/pace.12535. Epub 2014 Nov 27.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
Zbigniew Kalarus, MD, Ph.D. principal investigator
Department of Cardiology, Congenital Heart Diseases and Electrotherapy Medical University of Silesia, Silesian Center of Heart Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation in people with Atrial Fibrillation and Severe Heart Failure, run by Medical University of Silesia 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 6 inclusion and 19 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 7 Nov 2017. 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.
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 Zbigniew Kalarus, MD, Ph.D. (0048322713414, karzab@sum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant. (time frame: one year). The study lists 4 primary outcomes in all. 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 NCT03062241, which also lists 9 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 7 Nov 2017.