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Trial · NCT07405671

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryComposite safety outcome1 year
The primary outcome measure is a composite safety outcome including all-cause mortality, severe adverse events leading to drug discontinuation, and unscheduled hospitalisation for heart failure or acute coronary syndrome. Each of these individual components is assessed as secondary outcome.
SecondaryAll-cause mortality1 yearDeath from any cause
SecondarySevere adverse events leading to drug discontinuation1 year
Any severe AE leading to intervention discontinuation, including bradyarrhythmias, ventricular arrhythmias, atrial flutter with 1:1 conduction, QT/QRS prolongation, serious extra-cardiac adverse events
SecondaryUnscheduled hospitalisation for heart failure or acute coronary syndrome1 yearUnscheduled hospitalisation for heart failure or acute coronary syndrome
SecondaryAF recurrence1 yearFreedom from fast atrial arrhythmia post-treatment (clinical recurrence of AF)
SecondaryMajor adverse cardiovascular events1 yearComposite of cardiovascular death, myocardial infarction, stroke
SecondaryCatheter ablation1 yearIncidence of catheter ablation for AF during follow-up
SecondaryCardiovascular hospitalisation duration1 yearTotal number of days of cardiovascular hospitalisation
SecondaryTreatment-related adverse events1 year
All serious adverse events and adverse events: * Frequency and severity of all treatment-emergent adverse events * Proportion of participants experiencing at least one AE/SAE. * Specific drug-related adverse events (e.g., QT prolongation, proarrhythmia, bradycardia, hypotension, fatigue, gastrointestinal disturbances).
SecondaryCardiac function - LVEF3 monthsChanges in cardiac function assessed by left ventricular ejection fraction expressed in percentages (%) from baseline measured by echocardiography
SecondaryNT-proBNP3 monthsChange in N-terminal-pro-brain Natriuretic Peptide (NT-proBNP) at 3 months from baseline
SecondaryQTc1 yearChange in QTc interval (ms) and QRS duration (ms) from baseline
SecondaryHealthcare resource utilization1 yearTotal within-trial healthcare resource utilization expressed in Euro (€)
SecondaryAtrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire1 year
Change in patient reported outcomes assessed by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. The AFEQT questionnaire is a 20-item, disease-specific, patient-reported outcome measure ranging from 0 to 100 with a higher value corresponding to a better quality of life.
SecondaryEuroQoL-5 dimension health utility index (EQ-5D-5L)1 year
Change in patient-reported outcome as assessed by the EuroQoL-5 dimension health utility index (EQ-5D-5L) questionnaire. The EQ-5D-5L measures health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) on five severity levels (1=no problem to 5=extreme problem). Results are interpreted via a 5-digit health state profile (e.g., 11211), a calculated utility index (ranging from \<0 to 1, where 1=full health), and a 0-100 Visual Analog Scale (VAS). A higher score corresponds to a better quality of life.
SecondaryShort Form-12 (SF-12) health survey1 year
Change in patient-reported outcome as assessed by the Short Form-12 (SF-12) health survey. The Short Form-12 (SF-12) health survey is interpreted by calculating two main, norm-based scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-where a score of 50 represents the average for the general population. Scores above 50 indicate better-than-average health-related quality of life, while scores below 50 indicate below-average health.
SecondaryEHRA symptom score1 year
Change in patient-reported outcome as assessed by the European Heart Rhythm Association (EHRA) symptom score. The EHRA symptom score is a standardized, four-level classification system used to quantify the severity of symptoms in patients with atrial fibrillation based on how they impact daily activities. EHRA Symptom Score Classification (I-IV): EHRA I (Asymptomatic): No symptoms are experienced. EHRA II (Mild Symptoms): Normal daily activity is not affected. EHRA III (Severe Symptoms): Normal daily activity is affected. EHRA IV (Disabling Symptoms): Normal daily activity is discontinued.
SecondaryWork Productivity and Activity Impairment (WPAI) questionnaire1 year
Change in patient-reported outcome as assessed by the Work Productivity and Activity Impairment (WPAI) questionnaire. The WPAI questionnaire is interpreted by calculating four key impairment percentages over the past 7 days, with higher scores (0-100%) indicating greater impairment and lower productivity. It measures absenteeism (time missed), presenteeism (impairment while working), overall work loss, and daily activity impairment, using a 0-10 scale for productivity.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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GET https://conductscience.org/api/trials/v1/NCT07405671/registered