Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT (PPRA)
|ClinicalTrials.gov Identifier: NCT01594814|
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : December 15, 2014
Atrioventricular nodal reciprocating tachycardia (AVNRT) and atrioventricular reciprocating tachycardia (AVRT) are two similar supraventricular re-entry tachycardias (SVT) emerging in relatively young age in patients without apparent structural heart disease or significant comorbidities. The treatment of choice in those patients is radiofrequency ablation (RFA).
The PPRA study is a prospective observational study developed to thoroughly analyze quality of life, utility and willingness-to-pay of Polish patients undergoing RF ablation of AVNRT or AVRT.
Based on collected data the investigators will prepare a profile of patient who will benefit most from radiofrequency ablation and who should be scheduled in first place for the ablation in case of problems with accessibility to this service.
What is more an analysis of medical and indirect costs of care will be performed.
|Condition or disease||Intervention/treatment|
|Tachycardia, Atrioventricular Nodal Reentry Re-entrant Atrioventricular Tachycardia||Procedure: RFA|
|Study Type :||Observational|
|Actual Enrollment :||82 participants|
|Official Title:||Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT - a Quality of Life, Utility and Willingness to Pay Study (PPRA Study)|
|Study Start Date :||January 2012|
|Primary Completion Date :||November 2014|
|Study Completion Date :||November 2014|
|RFA of AVNRT of AVRT||
radiofrequency ablation of slow pathway or accesory pathway
- Health-related quality of life (HRQOL) [ Time Frame: two months ]Mean score of Patient Perception of Arrhythmia Questionnaire (PPAQ) - a disease-specific QoL questionnaire for patients suffering from supraventricular tachycardia translated and validated according to ISPOR (International Society For Pharmacoeconomics and Outcomes Research) guidelines
- Utility of health state [ Time Frame: two months ]Mean score of EQ-5D - a generic questionnaire measuring a health state utility (official Polish translation)
- Medical and indirect cost [ Time Frame: one year ]Cross-sectional data gathered using original questionnaire designed to measure medical and indiresct costs related to arrhythmia incurred during a year preceding RFA
- Willingness-to-pay [ Time Frame: one day ]a cross-sectional willingness-to-pay questionnaire studying hypothetical situation where RFA was not financed by Polish Health Fund
- Effectiveness [ Time Frame: two days ]Data on medical history, final diagnosis, outcome of treatment, safety and future recommendations
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594814
|Institute of Cardiology, II Dept. of Coronary Heart Disease|
|Warsaw, Poland, 02-637|
|Study Chair:||Mariusz Pytkowski, MD, PhD||Institute of Cardiology, Warsaw, Poland|
|Principal Investigator:||Michal M Farkowski, MD||Institute of Cardiology, Warsaw, Poland|