No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
65 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
1,250 (estimated)
Sponsor
Heart Care Foundation · Other
Who this trial is looking for
This trial is looking for older adults with Atrial Fibrillation who also have other long-term health issues. Participants will receive a specialized care plan to improve their health and quality of life.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 65 years old.
I have been diagnosed with Atrial Fibrillation.
I have at least one other long-term health condition.
You may not be able to join if
I have a mechanical heart valve or serious heart condition.
I do not want to enroll and sign the consent form.
I cannot understand the study or attend follow-up appointments.
I have a serious illness that limits my life expectancy to less than 12 months.
I am currently in another clinical trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 s…
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 .
Trial Locations
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State
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Status
Eligibility Criteria
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-te…
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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