Trial · NCT03845010
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Successful therapy | After 3 months | Number of patients reaching succesfull therapy defined as \>80% reduction of of VPB/VT burden after 3 months |
| Secondary | VPB/VT burden | 3, 6, 12 months after intervention | |
| Secondary | Change in VPB/VT burden | Before the intervention (baseline) and 3, 6, 12 months after intervention | Measurement in different subgroups e.g.: males, pre and post-menopausal women |
| Secondary | The impact in terms of total Quality of Life | 3, 6, 12 months after intervention compared to baseline (before intervention) | Use of the University of Toronto AF severity scale (AFSS) questionnaire to measure Quality of Life. The total score range is 0-35. Seven questions in total with a maximum score of 5 points per question. |
| Secondary | Association between number of VPB/hour and heart rate (HR)/hour during 24-hours Holter- monitoring | At baseline | A scatterplot will be made in order to depict the association between the number of VBP/hour and heart rate (HR)/hour during 24-hour Holter-monitoring |
| Secondary | Number of pro-arrhythmic effects, (non)-sustained VT or atrial flutter, in AAD arms with frequent visits and use of 24-hour Holter monitoring | 3, 6 and 12 months after intervention | |
| Secondary | QTc prolongation (sotalol) and QRS broadening (flecainide) with requiring frequent checks with standard ECG and/or treadmill test | 4-6 weeks after first administration of AAD | |
| Secondary | Complication rate of catheter ablation | Procedure and 3, 6 and 12 months after intervention | In all patients with special interest to the subgroup of patients with anatomically challenging origin of (non-RVOT) VPB/VTs |
| Secondary | Extended evaluation of left ventricular function with transthoracic echo (TTE) (including global longitudinal strain rate measurement) | Baseline, 6 and 12 months after intervention | |
| Secondary | Absolute and relative difference in VPB/VT burden (%) from baseline, during treatment with sotalol versus treatment with flecainide/verapamil | 3, 6 and 12 months after intervention | |
| Secondary | Divide patients in three groups depending on HR dependency of VPB/VT and compare absolute and relative difference in VPB/VT burden (%) from baseline, during treatment with sotalol versus treatment with flecainide/verapamil | 3, 6 and 12 months after intervention |
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/NCT03845010/registered