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New treatment option for Atrial Fibrillation (AF)
Official title Integrated Approach in Frail Older People with Atrial Fibrillation
ClinicalTrials.gov ID: NCT06775028
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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...
- ≥1 additional long-term comorbidity, thus fulfilling the definition of multimorbidity: hypertension (treated with at least 2 antihypertensive drugs)...
You likely can't join if
- 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 treatment studies. Only for sites assigned by chance to the iABC group: \- Patient without a device suitable for iABC use.
The study team makes the final eligibility decision.
Where it's taking place
- Haskovo, Bulgaria
- Pernik, Bulgaria
- Plovdiv, Bulgaria
- Sofia, Bulgaria
- Herlev, Denmark
- Hjørring, Denmark
- Horsens, Denmark
- Silkeborg, Denmark
- Caserta, CE, Italy
- Florence, FI, Italy
- Genova, GE, Italy
- Grosseto, GR, Italy
- Monza, MB, Italy
- Milan, MI, Italy
- Piacenza, PC, Italy
- Gubbio, PG, Italy
- Roma, RM, Italy
- Terni, TR, Italy
- Udine, UD, Italy
- Naples, Italy
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Haskovo, Bulgaria; Pernik, Bulgaria; Plovdiv, Bulgaria; Sofia, Bulgaria; Herlev, Denmark; Hjørring, Denmark and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.