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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Best Medical Treatment, ICD/CRT implant |
|
| B | Experimental | AF Ablation, ICD/CRT implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD/CRT implant | Device | Implantation of a ICD/ CRT device if not yet implanted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction (LVEF) by transthoracic echocardiography (TTE) | evaluated by Core Lab | 12months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of atrial tachyarrhythmia | diagnosed by daily ECG via ECG-recording card | 9 months |
| Exercise capacity in 6 min walk test | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl-Heinz Kuck, Prof. | Asklepios Klinik St. Georg - Hamburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herz- und Gefaesszentrum Bad Bevensen | Bad Bevensen | 29549 | Germany | |||
| Universitäts-Herzzentrum Freiburg - Bad Krozingen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31760819 | Derived | 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. |
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| AF ablation | Procedure | Atrial Fibrillation ablation by pulmonary vein isolation |
|
|
| Best Medical Treatment | Other | Best medical treatment according to current guidelines for Management of Patients with Atrial Fibrillation and for Management of Chronic Heart Failure. |
|
|
| Quality of life | assessed by Minnesota Quality of Life Questionnaire | 12 months |
| AF burden | assessed by ICD/CRT-D device memory in SJM devices | 9 months |
| Adverse events | 12 months |
| Mortality | 12 months |
| Number of adequate and inadequate ICD interventions | 12 months |
| Bad Krozingen |
| Germany |
| Kerckhoff-Klinik gGmbH | Bad Nauheim | Germany |
| Universitätsmedizin Berlin - Charité Campus Virchow-Klinikum (CVK) | Berlin | Germany |
| Herzzentrum Dresden | Dresden | 01307 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 20099 | Germany |
| Universitäres Herzzentrum Hamburg GmbH / UKE | Hamburg | Germany |
| Klinikum der Ruprecht-Karls-Universität Heidelberg | Heidelberg | Germany |
| Klinikum Ingolstadt GmbH | Ingolstadt | Germany |
| Herzzentrum Leipzig GmbH | Leipzig | 04289 | Germany |
| Klinikum der Stadt Ludwigshafen am Rhein gGmbH | Ludwigshafen | Germany |
| Klinikum Großhadern der Ludwig-Maximilians-Universität | München | Germany |
| Herzzentrum am Universitätsklinikum Münster | Münster | Germany |
| St. Adolf-Stift Reinbek | Reinbek | Germany |
| Semmelweis University | Budapest | Hungary |
| Hospital Universitari Clinic | Barcelona | Spain |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D004567 | Electrodes, Implanted |
| D019736 | Prostheses and Implants |
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