Trial · NCT07405671
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite safety outcome | 1 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. |
| Secondary | All-cause mortality | 1 year | Death from any cause |
| Secondary | Severe adverse events leading to drug discontinuation | 1 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 |
| Secondary | Unscheduled hospitalisation for heart failure or acute coronary syndrome | 1 year | Unscheduled hospitalisation for heart failure or acute coronary syndrome |
| Secondary | AF recurrence | 1 year | Freedom from fast atrial arrhythmia post-treatment (clinical recurrence of AF) |
| Secondary | Major adverse cardiovascular events | 1 year | Composite of cardiovascular death, myocardial infarction, stroke |
| Secondary | Catheter ablation | 1 year | Incidence of catheter ablation for AF during follow-up |
| Secondary | Cardiovascular hospitalisation duration | 1 year | Total number of days of cardiovascular hospitalisation |
| Secondary | Treatment-related adverse events | 1 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). |
| Secondary | Cardiac function - LVEF | 3 months | Changes in cardiac function assessed by left ventricular ejection fraction expressed in percentages (%) from baseline measured by echocardiography |
| Secondary | NT-proBNP | 3 months | Change in N-terminal-pro-brain Natriuretic Peptide (NT-proBNP) at 3 months from baseline |
| Secondary | QTc | 1 year | Change in QTc interval (ms) and QRS duration (ms) from baseline |
| Secondary | Healthcare resource utilization | 1 year | Total within-trial healthcare resource utilization expressed in Euro (€) |
| Secondary | Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire | 1 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. |
| Secondary | EuroQoL-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. |
| Secondary | Short Form-12 (SF-12) health survey | 1 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. |
| Secondary | EHRA symptom score | 1 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. |
| Secondary | Work Productivity and Activity Impairment (WPAI) questionnaire | 1 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07405671/registered