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Integrated Approach in Frail Older People with Atrial Fibrillation

RecruitingNAAges 65 Years - anyAllHeart Care Foundation
NCT06775028 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The study will verify if a structured multidisciplinary approach (called iABC), aimed to improve the appropriate management of elderly AF patients with multimorbidity (the i-ABC group), would provide a clear evidence of an improvement in clinical conditions and quality of life compared to usual clinical care. The i-ABC group in AFFIRMO will follow the ABC pathway, focused on three domains: avoid stroke with anticoagulation (with optimized VKA or label-adherent DOAC use); better symptom management; and optimized management of associated cardiovascular and non cardiovascular comorbidities. The study will be conducted in Bulgaria, Denmark, Italy, Romania, Serbia and Spain .

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📋 Eligibility rules (as published)
Inclusion Criteria: * Outpatients of both sexes with age ≥65 years; * First diagnosed, paroxysmal, persistent, long-standing persistent or permanent AF, confirmed as per guideline-recommended diagnostic criteria for AF, e.g. with electrocardiogram (ECG) or Holter monitoring; * ≥1 additional long-term comorbidity, thus fulfilling the definition of multimorbidity: hypertension (treated with at least 2 antihypertensive drugs), coronary artery disease (CAD), peripheral artery disease, heart failure, stroke/TIA, diabetes mellitus, COPD, CKD. Exclusion Criteria: * Mechanical prosthetic heart valve or moderate/severe mitral stenosis; * Patient unwilling to be enrolled and sign written informed consent; * Patient unable to understand the study and attend the follow-up; * Serious diseases with a life expectancy inferior to 12 months; * Patients included in other interventional studies. Only for sites randomized to the iABC group: \- Patient without a device suitable for iABC use.
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What it tests

  • iABC platform use
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Where

50 sites
MHAT Haskovo AD-Cardiology
Haskovo, Bulgaria
SHATS Sveti Georgi - Pernik-Cardiology
Pernik, Bulgaria
MBAL Sv. Ivan Rilski-Cardiology
Plovdiv, Bulgaria
UMBAL Sveti Georgi EAD-Clinic of Cardiology
Plovdiv, Bulgaria
UMHAT Pulmed Plovdiv-Cardiology
Plovdiv, Bulgaria
Acibadem City Clinic Tokuda Hospital-Dept of Electrophysiology Clinic of Cardiology
Sofia, Bulgaria
Acibadem City Clinic UMBAL Cardiovascular Center-CARDIOLOGY
Sofia, Bulgaria
National Heart Hospital-ICCU
Sofia, Bulgaria

…and 42 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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