Persistent Atrial FibrillationAMICANCT00652522
Atrial Fibrillation Management in Congestive Heart Failure With Ablation
A study testing ICD/CRT implant, AF ablation and Best Medical Treatment in people with Persistent Atrial Fibrillation and Heart Failure, run by Abbott Medical Devices at 16 sites in 3 countries.
Trial summary
It is the purpose of the study to show the benefit of the endocardial catheter ablation by pulmonary vein isolation in patients with persistent or longstanding persistent atrial fibrillation, low LVEF and requiring ICD or CRT-D therapy compared to the best medical treatment with antiarrhythmic drugs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Persistent Atrial Fibrillation, Heart Failure, ICD
- What is being tested?
- ICD/CRT implant, AF ablation and Best Medical Treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Jan 2008to 13 Jul 2017
- 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
- Having signed and dated Patient Informed Consent
- Having an indication for ICD or CRT-D therapy as indicated by current valid guidelines or having been implanted with an ICD or CRT-D
- Symptomatic atrial fibrillation (persistent AF (for a minimum of 1 week to a maximum of 1 year) or longstanding persistent AF (for a minimum of 1 year to a maximum of 4 years)) irrespective of the duration of paroxysmal AF
- Ejection fraction ≤ 35% as assessed by transthoracic echocardiography
- Left atrial diameter of less than 60 mm in parasternal diameter during transthoracic echocardiographic study
- ECG documentation of atrial fibrillation (ECG, Holter, event recorders, etc) related to symptomatic episodes
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- Having typical symptoms of heart failure NYHA II - III
- Patients > 30 days under optimal medical treatment for heart failure and CRT therapy in case of a pre-implanted CRT-D device
- Age 18 - 75 years
- Willing to participate in randomized trial
- Willing and able to participate in 12 months follow-up period
Who cannot join
- Longstanding persistent (> 4 years history) or paroxysmal atrial fibrillation
- Having a previously implanted pacemaker
- Having underlying valvular heart disease unless the disease has been corrected
- Patients with acute myocardial infarction
- Patients who have had previous pulmonary vein isolation procedures
- Patients with atrial fibrillation secondary to a reversible cause
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- Known presence of intracardiac or other thrombi
- Pregnant females or those of child bearing potential who have not had a negative pregnancy test within 48 hours before treatment
- Patients with other medical condition (i.e., cancer, alcoholism, drug abuse) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than one year)
- History of bleeding diathesis or suspected pro-coagulant state
- Contraindication to anticoagulation therapy
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Germany14 sites
Herz- und Gefaesszentrum Bad Bevensen
Bad Bevensen, 29549
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen
Kerckhoff-Klinik gGmbH
Bad Nauheim
Universitätsmedizin Berlin - Charité Campus Virchow-Klinikum (CVK)
Berlin
Herzzentrum Dresden
Dresden, 01307
Asklepios Klinik St. Georg
Hamburg, 20099
Universitäres Herzzentrum Hamburg GmbH / UKE
Hamburg
Klinikum der Ruprecht-Karls-Universität Heidelberg
Heidelberg
Klinikum Ingolstadt GmbH
Ingolstadt
Herzzentrum Leipzig GmbH
Leipzig, 04289
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen
Klinikum Großhadern der Ludwig-Maximilians-Universität
München
Herzzentrum am Universitätsklinikum Münster
Münster
St. Adolf-Stift Reinbek
Reinbek
About this study
It is the purpose of the study to show the benefit of the endocardial catheter ablation by pulmonary vein isolation in patients with persistent or longstanding persistent atrial fibrillation, low LVEF and requiring ICD or CRT-D therapy compared to the best medical treatment with antiarrhythmic drugs.
Read the detailed description
Atrial fibrillation is the most common sustained cardiac arrhythmia affecting 5% of people older than 65 years. It is associated with a 5 times increase of the risk of stroke in patients who are not receiving anticoagulant therapy and a doubling of the rate of death in all patients.
Congestive heart failure (CHF) and atrial fibrillation (AF) often co-exist, where one condition is promoting the development of the other and worsens its condition.
It is the purpose of the study to show the benefit of the endocardial catheter ablation by pulmonary vein isolation in patients with persistent (for a minimum of 1 week to a maximum of 1 year duration) or longstanding persistent (for a minimum of 1 year to a maximum of 4 years) atrial fibrillation, low LVEF (<=35%) and requiring ICD or CRT-D therapy compared to the best medical treatment with antiarrhythmic drugs.
Patients meeting the inclusion and exclusion criteria will be randomized in a 1:1 fashion in an unblinded, parallel arm treatment format to either drug therapy (directed at rate or rhythm control) or catheter ablation.
All therapies will be established and optimized in a 3 month treatment initiation phase (Blanking Period) starting with randomization. For all morbidity and mortality end-points, intention-to-treat analysis will begin at randomization. Efficacy with respect to AF treatment will be established for long-term follow up beginning after 3-month initiation phase.
Improvement of LVEF within 12 month is the primary endpoint of this study. The transthoracic echocardiographic (TTE) assessment at enrollment, discharge and 12 months follow-up follows a standardized protocol. The assessments are analyzed, calculated and expressed by an independent Core Lab.
- Conditions
- Persistent Atrial Fibrillation, Heart Failure, ICD
- Being tested
- ICD/CRT implant, AF ablation, Best Medical Treatment
- Keywords
- AF ablation, Pulmonary vein isolation(PVI), reduced LV ejection fraction, symptomatic atrial fibrillation, persistent AF
- 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.
ICD/CRT implantDevice
Also called ICDs/ CRT-Ds: All St. Jude Medical device, RA, RV and LV leads: St. Jude Medical CE-marked leads recommended
Implantation of a ICD/ CRT device if not yet implanted
AF ablationProcedure or surgery
Also called Catheters: St. Jude Medical CE-marked catheters recommended, NavX system for 3D mapping
Atrial Fibrillation ablation by pulmonary vein isolation
Best Medical TreatmentOther
Also called Conventional rate or rhythm control according valid guidelines
Best medical treatment according to current guidelines for Management of Patients with Atrial Fibrillation and for Management of Chronic Heart Failure.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Best Medical Treatment, ICD/CRT implant Receives: Device: ICD/CRT implant; Other: Best Medical Treatment |
| B | Experimental | AF Ablation, ICD/CRT implant Receives: Device: ICD/CRT implant; Procedure: AF ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction (LVEF) by transthoracic echocardiography (TTE)
evaluated by Core Lab
Measured: 12months
Secondary outcomes (7)
Recurrence of atrial tachyarrhythmia
diagnosed by daily ECG via ECG-recording card
Measured: 9 months
Exercise capacity in 6 min walk test
Measured: 12 months
Quality of life
assessed by Minnesota Quality of Life Questionnaire
Measured: 12 months
AF burden
assessed by ICD/CRT-D device memory in SJM devices
Measured: 9 months
Adverse events
Measured: 12 months
Mortality
Measured: 12 months
Number of adequate and inadequate ICD interventions
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startJan 2008
- Primary completion13 Jul 2017
- Study completion13 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl-Heinz Kuck, Prof., Principal investigator, Asklepios Klinik St. Georg - Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652522
- Sponsor's protocol ID
- AF06003AF
- Acronym
- AMICA
- Status last verified
- Jan 2019
- First submitted
- 20 Mar 2008
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kuck KH, Merkely B, Zahn R, Arentz T, Seidl K, Schluter M, Tilz RR, Piorkowski C, Geller L, Kleemann T, Hindricks G. Catheter Ablation Versus Best Medical Therapy in Patients With Persistent Atrial Fibrillation and Congestive Heart Failure: The Randomized AMICA Trial. Circ Arrhythm Electrophysiol. 2019 Dec;12(12):e007731. doi: 10.1161/CIRCEP.119.007731. Epub 2019 Nov 25.
PubMed 31760819
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Management in Congestive Heart Failure With Ablation
- ClinicalTrials.gov ID
- NCT00652522
- Acronym / sponsor ID
- AMICA / AF06003AF
- Conditions
- Persistent Atrial Fibrillation, Heart Failure, ICD
- Keywords
- AF ablation, Pulmonary vein isolation(PVI), reduced LV ejection fraction, symptomatic atrial fibrillation, persistent AF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2008 (actual)
- Primary completion
- 13 Jul 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 3 Apr 2008 (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.
It is the purpose of the study to show the benefit of the endocardial catheter ablation by pulmonary vein isolation in patients with persistent or longstanding persistent atrial fibrillation, low LVEF and requiring ICD or CRT-D therapy compared to the best medical treatment with antiarrhythmic drugs.
Detailed description
Atrial fibrillation is the most common sustained cardiac arrhythmia affecting 5% of people older than 65 years. It is associated with a 5 times increase of the risk of stroke in patients who are not receiving anticoagulant therapy and a doubling of the rate of death in all patients.
Congestive heart failure (CHF) and atrial fibrillation (AF) often co-exist, where one condition is promoting the development of the other and worsens its condition.
It is the purpose of the study to show the benefit of the endocardial catheter ablation by pulmonary vein isolation in patients with persistent (for a minimum of 1 week to a maximum of 1 year duration) or longstanding persistent (for a minimum of 1 year to a maximum of 4 years) atrial fibrillation, low LVEF (<=35%) and requiring ICD or CRT-D therapy compared to the best medical treatment with antiarrhythmic drugs.
Patients meeting the inclusion and exclusion criteria will be randomized in a 1:1 fashion in an unblinded, parallel arm treatment format to either drug therapy (directed at rate or rhythm control) or catheter ablation.
All therapies will be established and optimized in a 3 month treatment initiation phase (Blanking Period) starting with randomization. For all morbidity and mortality end-points, intention-to-treat analysis will begin at randomization. Efficacy with respect to AF treatment will be established for long-term follow up beginning after 3-month initiation phase.
Improvement of LVEF within 12 month is the primary endpoint of this study. The transthoracic echocardiographic (TTE) assessment at enrollment, discharge and 12 months follow-up follows a standardized protocol. The assessments are analyzed, calculated and expressed by an independent Core Lab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: ICD/CRT implant, Other: Best Medical TreatmentBest Medical Treatment, ICD/CRT implant |
| B | Experimental | Device: ICD/CRT implant, Procedure: AF ablationAF Ablation, ICD/CRT implant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Having signed and dated Patient Informed Consent
- Having an indication for ICD or CRT-D therapy as indicated by current valid guidelines or having been implanted with an ICD or CRT-D
- Symptomatic atrial fibrillation (persistent AF (for a minimum of 1 week to a maximum of 1 year) or longstanding persistent AF (for a minimum of 1 year to a maximum of 4 years)) irrespective of the duration of paroxysmal AF
- Ejection fraction ≤ 35% as assessed by transthoracic echocardiography
- Left atrial diameter of less than 60 mm in parasternal diameter during transthoracic echocardiographic study
Key exclusion criteria (11 listed)
- Longstanding persistent (> 4 years history) or paroxysmal atrial fibrillation
- Having a previously implanted pacemaker
- Having underlying valvular heart disease unless the disease has been corrected
- Patients with acute myocardial infarction
- Patients who have had previous pulmonary vein isolation procedures
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 |
|---|---|---|
| ICD/CRT implantAlso: ICDs/ CRT-Ds: All St. Jude Medical device, RA, RV and LV leads: St. Jude Medical CE-marked leads recommendedImplantation of a ICD/ CRT device if not yet implanted | Device | A, B |
| AF ablationAlso: Catheters: St. Jude Medical CE-marked catheters recommended, NavX system for 3D mappingAtrial Fibrillation ablation by pulmonary vein isolation | Procedure or surgery | B |
| Best Medical TreatmentAlso: Conventional rate or rhythm control according valid guidelinesBest medical treatment according to current guidelines for Management of Patients with Atrial Fibrillation and for Management of Chronic Heart Failure. | Other | A |
Primary outcome
Left ventricular ejection fraction (LVEF) by transthoracic echocardiography (TTE)
Time frame: 12months
evaluated by Core Lab
7 secondary outcomes
Recurrence of atrial tachyarrhythmia
Time frame: 9 months
Exercise capacity in 6 min walk test
Time frame: 12 months
Quality of life
Time frame: 12 months
AF burden
Time frame: 9 months
Adverse events
Time frame: 12 months
Mortality
Time frame: 12 months
Number of adequate and inadequate ICD interventions
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Derived from this study: PubMed 31760819Kuck KH, Merkely B, Zahn R, Arentz T, Seidl K, Schluter M, Tilz RR, Piorkowski C, Geller L, Kleemann T, Hindricks G. Catheter Ablation Versus Best Medical Therapy in Patients With Persistent Atrial Fibrillation and Congestive Heart Failure: The Randomized AMICA Trial. Circ Arrhythm Electrophysiol. 2019 Dec;12(12):e007731. doi: 10.1161/CIRCEP.119.007731. Epub 2019 Nov 25.
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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.
Karl-Heinz Kuck, Prof. principal investigator
Asklepios Klinik St. Georg - Hamburg
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICD/CRT implant, AF ablation and Best Medical Treatment in people with Persistent Atrial Fibrillation and Heart Failure, run by Abbott Medical Devices at 16 sites in 3 countries.
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 11 inclusion and 11 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: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, Hungary, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (LVEF) by transthoracic echocardiography (TTE) (time frame: 12months). 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 NCT00652522, which also lists 1 linked publication.
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 4 Feb 2019.