Atrial FibrillationAFICHENCT03573869
Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)
A study testing Cryoballoon ablation in people with Atrial Fibrillation and Heart Failure, Systolic, run by G.Gennimatas General Hospital at 1 site in Greece.
Trial summary
In this study 404 patients with heart failure and an ejection fraction of 0.40 or less, with paroxysmal atrial fibrillation, will be randomly assigned to standard treatment or standard treatment plus a session of cryoballoon ablation (left atrial balloon cryoablation for pulmonary vein isolation). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation, Heart Failure, Systolic
- What is being tested?
- Cryoballoon ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2018to 1 Jun 2022
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A minimum of at least two separate AF episodes recorded within the last 12 months, either on 12-lead rest ECG or on ambulatory ECG recordings (at least 5 minutes of AF on Holter recordings will be required),
- LVEF <40% on sinus rhythm,
- symptoms consistent with heart failure (New York Heart Association II or higher) despite rate control treatment,
- age >21 years old.
Who cannot join
- previous left atrial ablation,
- left atrial diameter >28 mm/m2 BSA on TTE (parasternal long axis view),
- strong clinical suspicion that reduced LVEF is primarily due to tachycardiomyopathy,
- pre-existing device (ICD or CRT) without AF detection algorithms and/or (for CRT devices) diagnostics of effective biventricular pacing,
- known primary electrical heart disease (e.g. Brugada syndrome),
- presence of thrombus in a heart chamber,
Show all 12Show fewer
- presence of prosthetic valve at any position,
- moderate/severe valvular heart disease,
- active infectious disease or malignancy,
- moderate or severe hepatic impairment (Child-Pugh class B or C),
- severe renal failure (estimated glomerular filtration rate <20 ml/min/1.73 m2),
- inability or unwillingness to adhere to standard treatment or to provide consent.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Athens General Hospital "G. Gennimatas"
Athens, 11527
Charalampos Kossyvakis, MD, PhD, 00302107768560, ckossyvakis@gmail.com
Georgios Giannopoulos, MD,PhD, 00302107768244, ggiann@med.uoa.gr
About this study
Official title: Effect of Cryoballoon Pulmonary Vein Isolation on Atrial Fibrillation Burden and Clinical Endpoints in Patients With Heart Failure With Impaired Left Ventricular Systolic Function
In this study 404 patients with heart failure and an ejection fraction of 0.40 or less, with paroxysmal atrial fibrillation, will be randomly assigned to standard treatment or standard treatment plus a session of cryoballoon ablation (left atrial balloon cryoablation for pulmonary vein isolation). All patients with either have an ICD or CRT-D/P device implanted or an implantable electrocardiographic monitoring device. The primary study endpoint will be the time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time).16 This AF burden corresponds to 7.2 hours per month.
A powered secondary endpoint will be the time to the composite of all-cause mortality and unplanned hospitalization for heart failure.
- Conditions
- Atrial Fibrillation, Heart Failure, Systolic
- Being tested
- Cryoballoon ablation
- Medical subject headings
- Atrial Fibrillation, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoballoon ablationProcedure or surgery
Left atrial ablation using cryoballoon to achieve pulmonary vein isolation
| Study group | Role | What they receive |
|---|---|---|
| Cryoballoon ablation | Experimental | A 28-mm cryoballoon (Arctic Front Advance™ Cardiac CryoAblation Catheter, Medtronic, Minneapolis, MN) will be employed. The cryoballoon catheter will be introduced into the left atrium, following a single transeptal puncture, through a 12F FlexCath steerable sheath (Medtronic), constantly flushed with heparinized saline. A circular mapping catheter (Achieve, Medtronic) will be advanced through the cryoballoon to the PV orifice and positioned as proximally as possible inside the vessel to record the PV potentials at baseline and monitor the isolation procedure in real time. Receives: Procedure: Cryoballoon ablation |
| Standard treatment | No intervention | Standard treatment, including at least one rhythm control medication, on top of optimized rate control and HF treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to exceed AG burden cut-off of 1%
The time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time)
Measured: Up to 2 years
Secondary outcomes (1)
All-cause mortality or hospitalization for heart failure
Time to the composite of all-cause mortality and unplanned hospitalization for heart failure
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start1 Jun 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G.Gennimatas General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Spyridon Deftereos, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573869
- Sponsor's protocol ID
- 39052/21-12-17
- Acronym
- AFICHE
- Status last verified
- Jul 2018
- First submitted
- 8 Jun 2018
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cryoballoon Pulmonary Vein Isolation on Atrial Fibrillation Burden and Clinical Endpoints in Patients With Heart Failure With Impaired Left Ventricular Systolic Function
- ClinicalTrials.gov ID
- NCT03573869
- Acronym / sponsor ID
- AFICHE / 39052/21-12-17
- Conditions
- Atrial Fibrillation, Heart Failure, Systolic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- G.Gennimatas General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 29 Jun 2018 (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.
In this study 404 patients with heart failure and an ejection fraction of 0.40 or less, with paroxysmal atrial fibrillation, will be randomly assigned to standard treatment or standard treatment plus a session of cryoballoon ablation (left atrial balloon cryoablation for pulmonary vein isolation). All patients with either have an ICD or CRT-D/P device implanted or an implantable electrocardiographic monitoring device. The primary study endpoint will be the time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time).16 This AF burden corresponds to 7.2 hours per month.
A powered secondary endpoint will be the time to the composite of all-cause mortality and unplanned hospitalization for heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoballoon ablation | Experimental | Procedure: Cryoballoon ablationA 28-mm cryoballoon (Arctic Front Advance™ Cardiac CryoAblation Catheter, Medtronic, Minneapolis, MN) will be employed. The cryoballoon catheter will be introduced into the left atrium, following a single transeptal puncture, through a 12F FlexCath steerable sheath (Medtronic), constantly flushed with heparinized saline. A circular mapping catheter (Achieve, Medtronic) will be advanced through the cryoballoon to the PV orifice and positioned as proximally as possible inside the vessel to record the PV potentials at baseline and monitor the isolation procedure in real time. |
| Standard treatment | No intervention | –Standard treatment, including at least one rhythm control medication, on top of optimized rate control and HF treatment |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A minimum of at least two separate AF episodes recorded within the last 12 months, either on 12-lead rest ECG or on ambulatory ECG recordings (at least 5 minutes of AF on Holter recordings will be required),
- LVEF <40% on sinus rhythm,
- symptoms consistent with heart failure (New York Heart Association II or higher) despite rate control treatment,
- age >21 years old.
Key exclusion criteria (12 listed)
- previous left atrial ablation,
- left atrial diameter >28 mm/m2 BSA on TTE (parasternal long axis view),
- strong clinical suspicion that reduced LVEF is primarily due to tachycardiomyopathy,
- pre-existing device (ICD or CRT) without AF detection algorithms and/or (for CRT devices) diagnostics of effective biventricular pacing,
- known primary electrical heart disease (e.g. Brugada 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 |
|---|---|---|
| Cryoballoon ablationLeft atrial ablation using cryoballoon to achieve pulmonary vein isolation | Procedure or surgery | Cryoballoon ablation |
Primary outcome
Time to exceed AG burden cut-off of 1%
Time frame: Up to 2 years
The time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time)
1 secondary outcome
All-cause mortality or hospitalization for heart failure
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoballoon ablation in people with Atrial Fibrillation and Heart Failure, Systolic, run by G.Gennimatas General Hospital at 1 site in Greece.
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 4 inclusion and 12 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 9 Jul 2018. 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 Greece. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to exceed AG burden cut-off of 1% (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2018.