Registered outcomes18

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

1 to 18 of 18

List	Outcome	Time frame	Description
Primary	Proportion of patients free from first atrial tachyarrhythmia recurrence lasting 6 minutes or longer	12 months after initiation of allocated treatment excluding the first 3 months blanking period	In the absence of antiarrhythmic drugs in ablation group as documented by an implantable cardiac monitor from initiation of treatment.
Secondary	Total atrial arrhythmia burden (percentage of time in AF/AT)	baseline,12, 24, 36 months after initiation of treatment excluding the 3 months blanking period	Measured from the continuous implantable cardiac monitor with a 6 minutes AF episode detection cut-off limit.
Secondary	AF progression and reversion	baseline,12, 24, 36 months follow-up excluding 3 months blanking period	Progression to longstanding persistent or permanent AF/AT and regression going in opposite direction from persistent to paroxysmal AF or to sinus rhythm. Measured as combination of reduced number of progressions or increased number of AF/AT regression .
Secondary	Generic Health Related Quality of life (HRQoL)	baseline, 12, 24, 36 months follow-up	Generic Medical Outcomes Study Short Form-36 (SF-36) quality of life questionnaire using 8 subscales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Scores from 0 to 100; lower scores poorer QoL.
Secondary	Symptoms	baseline, 12, 24, 36 months after initiation of treatment	European Heart Rhythm Association (EHRA) Symptom Classification assessing the severity of AF related symptoms
Secondary	AF specific Health Related Quality of Life	baseline, 12, 24, 36 months after initiation of treatment excluding the 3 months blanking period	Assessed by University of Toronto Atrial Fibrillation Severity Scale (AFSS); 19-item AF-specific scale; ratings AF including 4 categories; 1. AF burden (calculated from modified sum of frequency, duration and severity of episodes); Total AF Burden=AF frequency + AF duration + AF severity. Each of 3 measures contributes equally to Total AF Burden score, and varies from 1-10 to yield Total AF Burden scores ranging from 3-30 where higher scores indicate greater AF burden. 2. Global Well Being (visual analogue scale 1-10; worst - best possible life); 3. AF Symptom Score (sum of 7 items on specified symptoms); For each of 7 questions (answers vary from 0=I have not had this symptom in past 4 weeks to 5=A great deal), values determined and summed together to form a total score (0-35). This score assumes linearity of severity. 4. Health Care Utilization (number of cardioversions, ablations, emergency room visits, hospitalizations due to arrhythmia, and specialist appointments).
Secondary	Cognitive function	baseline,12, 24, 36 months after initiation of treatment	Trail Making Test (TMT) parts A and B. Patient is asked to draw lines from figures in consecutive orders n 1-2-3 etc (TMT A) and from figures to letters 1-A-2-B etc.(TMT B) Examiner starts timing both part A and B and counts errors made. The Time in seconds and Number of errors are counted for both A and B test. The rhythm and pulse at the time of the evaluation will be recorded but is not used as a measure other than a binary value for correlation with cognitive function.
Secondary	Rate of Healthcare utilizations for cardiovascular reasons	baseline,12, 24, 36 months after initiation of treatment excluding the 3 months blanking period	Number of cardioversions, ablations, drug initiations, cardiovascular hospitalizations, emergency department visits and unplanned outpatient visits and its relation to AF/AT burden. Cardiovascular means related to AF including any treatment or diagnostic procedure for AF/AT, i.e. cardioversions, medication, further AF ablations after AF/AT recurrence, or any adverse events related to AF/AT or its treatment (acute stroke), heart failure, myocardial ischemic events; adverse events (eg. pacemaker implantation).
Secondary	Cost-effectiveness analysis by EuroQol-5 Dimensions (EQ-5D)	36 months	Quality-adjusted life years (QALYs) using EQ-5D; QALYs will then be incorporated with medical costs; cost/QALY to compare the treatments. i) EQ-5D descriptive system with five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 5 levels. Digits combined into a 5-digit number for patient's health state. ii) Visual analogue vertical line scale (EQ-VAS) with endpoints labelled 'The best and worst health you can imagine' as a quantitative measure of health outcome reflecting patient's own judgement. Cost-effectiveness analysis of the treatments examining costs and health outcomes of the two interventions. It compares the interventions by estimating how much it costs to gain a unit of a health outcome.
Secondary	Proportion of patients with Reverse atrial remodeling	baseline, 12, 24 and 36 months	Proportion of patients with Reverse atrial remodeling as defined by at least 15% decrease of Left atrial maximal volume index (ml/m2) or increase of left atrial strain during reservoir phase (percentage) or left atrial strain during contraction phase (percentage) versus baseline.
Secondary	Proportion of patients free from ECG documented atrial tachyarrhythmia recurrence lasting 6 minutes or longer after the 1st and last ablation procedure respectively	36 months	Defined as single and multiple procedure success
Secondary	Adverse events	12, 24, 36 months	Type and frequency of adverse events and serious adverse events related or not to treatment.
Secondary	Numbers of withdrawals / 'cross-overs'	12, 24, 36 months	Frequency of withdrawals / 'cross-overs' in each treatment group
Secondary	Covariate adjusted primary endpoint freedom from first atrial tachyarrhythmia recurrence lasting 6 minutes or longer	12 and 36 months	Analysis using following covariates at baseline: coronary artery disease, hypertension, left atrial volume index.
Other	Predictors of non-responders by 4-Structured - AF characterization and conventional risk factors	12 and 24 months	Structured AF (4S-AF) characterization assessing; 1. Stroke risk; No Oral Anticoagulation (OAC) or OAC = 0 - 1 point. 2. Symptom severity by European Heart Rhythm Association (EHRA) Symptom (0 point = EHRA score 1-2a; 1 point = EHRA score 2b; 2 points = EHRA score 3-4). 3. Severity AF/AT burden (0 point = short, infrequent, 1 point = intermediate and/or frequent; 2 points = long or very frequent). 4. Substrate: Comorbidity/Left atrial enlargement (0 point = none; 1 = single/mild moderate; 2 points = multiple/ severe). Add +1 point if age \>75 years. Sum of points will be correlated to treatment responder, defined as sinus rhythm at 12 months without AF/AT recurrences, versus conventional. Conventional risk factors for AF/AT recurrence: 1. AF history, (months) 2. P wave duration (milliseconds) 3. LAVI (mL/m2) and atrial strain (percentage) by echocardiography 4. NTpro-BNP (ng/L) 5. BMI (kg/m2) 6. CHA2DS2vasc score (0-10)
Other	Blood pressure, systolic	baseline,12, 24, 36 months after initiation of treatment	Measured after 10 minutes rest by (mmHg).
Other	Blood pressure, diastolic (mmHg).	baseline,12, 24, 36 months after initiation of treatment	Measured after 10 minutes rest by (mmHg).
Other	Rhythm at time of responding to quality of life questionnaire	baseline, 12, 24, 36 months	Rhythm (atrial fibrillation or sinus rhythm) recorded at time of quality of life assessment for evaluation if correlated to QoL.

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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