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There is evidence of superiority of AV junction ablation strategy over pharmacological therapy only for symptoms of atrial fibrillation, but not for heart failure, hospitalization, morbidity and mortality. Hypothesis of trial is that AV junction ablation is superior to pharmacological therapy as regard hospitalization and mortality
Prospective randomized, controlled, investigator-initiated trial which consists of two specific consecutive(overlapped) phases:
"Morbidity trial" (APAF-CRT morbidity). Small size (280 pts), follow-up 24 months. Primary endpoint: combined of mortality due to heartfailure, hospitalization for heart failure or atrial fibrillation or worsening heart failure. Predefined subgroup analysis for patients with ejection fraction ≤35% versus >35%
"Mortality trial" (APAF-CRT mortality). Large size (pts included in morbidity trial plus additional ~1500 pts, long-term follow-up (at least 4 years). Primary endpoint: total mortality. Predefined subgroup analysis for patients with ejection fraction ≤35% versus >35%
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug therapy | Experimental | Control Arm: optimized drug therapy (plus implantable defibrillator (ICD) according to guidelines) |
|
| Device: AV junction ablation & CRT | Active Comparator | AV junction ablation + CRT (CRT-P or CRT-D according to guidelines) + optimized drug therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AV junction ablation | Procedure | AV junction ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined end-point | "Morbidity trial" end-points Primary end-point: a combined of (1) mortality due to heart failure, (2) hospitalization for heart failure or uncontrolled intolerable atrial fibrillation, or (3) worsening heart failure | Upto 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Major clinical events | "Morbidity trial" end-points Secondary end-points: total mortality, total hospitalizations, hospitalization for heart failure and/or atrial fibrillation and worsening heart failure. | Up to 3 years |
| Major clinical events |
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Inclusion Criteria:
To be eligible, each patient must be in the following condition:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele Brignole, MD | Contact | +39 0185 329567 | mbrignole@asl4.liguria.it |
| Name | Affiliation | Role |
|---|---|---|
| Claudio Marsano, MD | Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Ospedali del Tigullio | Recruiting | Lavagna | 16033 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22187425 | Background | Chatterjee NA, Upadhyay GA, Ellenbogen KA, McAlister FA, Choudhry NK, Singh JP. Atrioventricular nodal ablation in atrial fibrillation: a meta-analysis and systematic review. Circ Arrhythm Electrophysiol. 2012 Feb;5(1):68-76. doi: 10.1161/CIRCEP.111.967810. Epub 2011 Dec 20. | |
| 21606084 | Result | Brignole M, Botto G, Mont L, Iacopino S, De Marchi G, Oddone D, Luzi M, Tolosana JM, Navazio A, Menozzi C. Cardiac resynchronization therapy in patients undergoing atrioventricular junction ablation for permanent atrial fibrillation: a randomized trial. Eur Heart J. 2011 Oct;32(19):2420-9. doi: 10.1093/eurheartj/ehr162. Epub 2011 May 23. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D047548 | Defibrillators |
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| CRT | Device | Implantation of device for pacing and cardiac resynchronization therapy (CRT-P or CRT-D according to guidelines) |
|
|
| Optimized drug therapy | Drug | Optimized drug therapy for heart failure and atrial fibrillation rate control |
|
|
| ICD | Device | Implantable defibrillator (in control Group or in association with CRT in study Group) according to guidelines |
|
|
"Mortality trial" end-points Secondary end-point: cardiovascular mortality and hospitalization for heart failure or uncontrolled intolerable atrial fibrillation
| Up to 5 years |
| 34453840 | Derived | Brignole M, Pentimalli F, Palmisano P, Landolina M, Quartieri F, Occhetta E, Calo L, Mascia G, Mont L, Vernooy K, van Dijk V, Allaart C, Fauchier L, Gasparini M, Parati G, Soranna D, Rienstra M, Van Gelder IC; APAF-CRT Trial Investigators. AV junction ablation and cardiac resynchronization for patients with permanent atrial fibrillation and narrow QRS: the APAF-CRT mortality trial. Eur Heart J. 2021 Dec 7;42(46):4731-4739. doi: 10.1093/eurheartj/ehab569. |
| 30165479 | Derived | Brignole M, Pokushalov E, Pentimalli F, Palmisano P, Chieffo E, Occhetta E, Quartieri F, Calo L, Ungar A, Mont L; APAF-CRT Investigators. A randomized controlled trial of atrioventricular junction ablation and cardiac resynchronization therapy in patients with permanent atrial fibrillation and narrow QRS. Eur Heart J. 2018 Dec 1;39(45):3999-4008. doi: 10.1093/eurheartj/ehy555. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004566 |
| Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D004567 | Electrodes, Implanted |
| D019736 | Prostheses and Implants |