Clinical Research Directory

mHealth Rhythm Management in Terms of Cancelling Unnecessary Scheduled ECVs in Presumed Persistent AFpatients.

Despite a clear definition in the European Society of Cardiology (ESC) guidelines, the differentiation between paroxysmal (self-terminating) and persistent (nonself- terminating) atrial fibrillation (AF) remains challenging in clinical practice. Some patients with presumed persistent AF are planned for electrical cardioversion (ECV) but appear to have a paroxysmal pattern or present in sinus rhythm (SR) at the scheduled ECV appointment. This results in unnecessary visits or interventions for patients, and costs and burden for the hospitals and health insurances. Based on the feasibility of the TeleCheck-AF approach, which is an on-demand mobile health (mHealth) infrastructure incorporating app-based heart rate and rhythm monitoring to support remote AF management through teleconsultation, the investigators aim to extend this mHealth approach to the management of presumed persistent AF patients planned for ECV.

Diagnostic Electrical Cardioversion for Explaining Patient's AF and HF Symptoms

Rationale: The co-existence of Atrial Fibrillation (AF) and Heart Failure (HF) is associated with increased morbidity, mortality, and hospital admissions, significantly contributing to healthcare burden. Patients often experience overlapping symptoms, complicating identifying the disease primarily responsible for symptom burden. Electrical cardioversion (ECV) has been suggested to assess symptom status in sinus rhythm. However, the role of a diagnostic ECV in patients with AF and concomitant HF has not been established. The hypothesis of this trial is that a diagnostic ECV can provide insight into AF-specific and HF-specific symptoms that can inform the physician and subsequently lead to treatment changes, as well as improve quality of life (QoL), and result changes in ejection fraction, cardiac output, and NT-proBNP levels. Objective: To assess whether a diagnostic ECV results in more treatment changes after 3 months, compared to standard of care (no ECV). Study design: This is an investigator initiated, randomized, open label with blinded endpoint evaluation, multi-centre, trial. Study population: 112 patients with chronic HF and ECG confirmed persistent AF. Trial intervention: Patients will be randomized in a 1:1 ratio to either an ECV or standard of care with pharmacological rate and/or rhythm control. Main study parameters/endpoints: The primary outcome: total number of treatment alterations by the physician during 3 months post intervention/randomization. Secondary outcomes: Success rate of ECV, recurrences of AF at 4 weeks, QoL changes assessed by AFEQT and KCCQ score, echocardiographic changes (left ventricular ejection fraction (LVEF) and cardiac output (CO)), and laboratory changes (NT-proBNP) between baseline (pre-cardioversion) and 4 weeks (post-cardioversion). Whether the physician can distinguish AF from HF symptoms and whether ECV can be used as diagnostic tool. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since this is a pragmatic trial, the study will be embedded within care according to current AF and HF guidelines, that includes ECV and rhythm and/or rate control, while acknowledging wide variability in local practises. The patients in the intervention arm will undergo a diagnostic ECV. Both groups will fill out questionnaires regarding QoL (baseline and 4 weeks) and have an echocardiogram at 4 weeks. A blinded endpoint committee will assess potential treatment alterations prescribed by the physician in both patient groups within 3 months. No harm is expected for this study as the intervention will be based on national guidelines.