Trial · NCT02294955
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | quality of life | 12 months | General Health related Quality of Life; Short Form (SF) 36 |
| Secondary | atrial fibrillation burden | 12, 24, 36 and 48 months | Total time spent in and number of episodes of atrial fibrillation, Frequency of symptomatic respectively asymptomatic episodes of AF assessed by implantable event recorder. |
| Secondary | Composite of morbidity | 12, 24, 36 and 48 months | Stroke, systemic embolic events, transient ischemic attack (TIA), major bleeding, cardiovascular hospitalizations, pacemaker implantation, all cause Death. |
| Secondary | Hospitalization | 12, 24, 36 and 48 months | Total number of hospitalization days and time to first event of hospitalization days due to cardiovascular reasons and atrial fibrillation |
| Secondary | Quality of Life | 12, 24, 36 and 48 months | Quality of Life by SF-36, all domains and time-points; symptom severity score (SSQ); European Heart Rhythm Association (EHRA) Symptom Classification. |
| Secondary | Health care use and economy | 24 and 48 months | EuroQoL (EQ) 5D, a standardised instrument for measure of health outcome, COSTs for hospitalization and outpatient visits related to and not related to AF, treatment costs, and including corrections for background variables regarding social economic status. |
| Secondary | Success of treatment | 12 and 48 months | Baseline predictors for symptom-based response (symptom success) and rhythm-based response. |
| Secondary | Physical capacity | 12, 24, 36 and 48 months | Exercise/Physical capacity and % of predicted max. as well as duration |
| Secondary | Atrial area and function | 12, 24, 36 and 48 months | Left atrial area and function, Right atrial area and function (from Echocardiography and corrected for body surface area. |
| Secondary | Adverse events | 12, 24, 36 and 48 months | Incidence, intensity and relationship of Adverse Events |
| Secondary | Recurrence of episodes of AF lasting at least one minute. | 12, 24, 36 and 48 months | After four weeks stabilization period, obtained from the implantable cardiac monitor and 24 hour Holter recordings and extra visits related to AF. |
| Secondary | Success/failure of treatment. | 12, 24, 36, 48 months | Success/failure (yes/no) with regard to symptoms and rhythm. |
| Other | Covariate adjusted primary endpoint | 12, 24, 36 and 48 months | Analysis of primary endpoint using following covariates at baseline: age, sex, background variables regarding social economic status, BMI, paroxysmal or persistent AF type I or II, coronary artery disease, hypertension, diabetes, congestive heart failure, failure of an antiarrhythmic drug class I or III prior to randomization, present medication and duration of AF |
| Other | Recurrence of episodes of AF lasting at least one minute | 12, 24, 36 and 48 months | Recurrence of episodes of AF lasting at least one minute (after four weeks stabilization period), obtained from the ICM continuously and 24 hour Holter recordings and extra visits related to AF cardioversion). |
| Other | Baseline predictors for symptom-based response and rhythm-based response. | 12, 24, 36 and 48 months | Logistic multiple regression analysis to identify baseline predictors for symptom-based response (symptom success) and rhythm-based response (rhythm success if absence of AF episodes duration \> 1 minute after last therapy), respectively (yes/no) by treatment Group. |
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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