Permanent Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Heart failure, Catheter ablation, Cardiac resynchronization therapy, Implantable defibrillator
Brief summary
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
Detailed description
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%
Interventions
PROCEDUREAV junction ablation
AV junction ablation
DEVICECRT
Implantation of device for pacing and cardiac resynchronization therapy (CRT-P or CRT-D according to guidelines)
DRUGOptimized drug therapy
Optimized drug therapy for heart failure and atrial fibrillation rate control
DEVICEICD
Implantable defibrillator (in control Group or in association with CRT in study Group) according to guidelines
Sponsors
Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be eligible, each patient must be in the following condition: 1. Permanent atrial fibrillation (\>6 months) which has been considered unsuitable for ablation or failed ablation 2. Narrow QRS ≤ 110 ms 3. Severely symptomatic (atrial fibrillation-related symptoms), refractory to drug therapy for rate control 4. At least one hospitalization related to atrial fibrillation and/or heart failure in the previous year (see definition below)
Exclusion criteria
1. New York Heart Association (NYHA) class IV and systolic blood pressure \<80 mmHg despite optimized therapy; 2. severe concomitant non-cardiac disease; 3. need for surgical intervention; 4. myocardial infarction within the previous 3 months; 5. previous implanted devices (PM/ICD/CRT)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined end-point | Upto 3 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major clinical events | Up to 3 years | Morbidity trial end-points Secondary end-points: total mortality, total hospitalizations, hospitalization for heart failure and/or atrial fibrillation and worsening heart failure. |
Countries
Italy
Contacts
Primary ContactMichele Brignole, MD
Outcome results
None listed