Clinical trial NCT01594814: Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tachycardia, Atrioventricular Nodal Reentry
Re-entrant Atrioventricular Tachycardia
Keywords: AVNRT
AVRT
WPW
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2012-05-09
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients scheduled for ablation of AVNRT, AVRT or SVT will be eligible for the study.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent
2. Age above 18
3. Scheduled RFA due to AVNRT or AVRT
4. Sufficient knowledge of the Polish language to independently complete the questionnaires

Exclusion Criteria:

1. No written informed consent
2. Health states significantly impairing QoL (eg. stroke, advanced heart failure)

Primary outcomes:
measure: Health-related quality of life (HRQOL)
timeFrame: two months
Secondary outcomes:
measure: Utility of health state
timeFrame: two months
measure: Medical and indirect cost
timeFrame: one year
measure: Willingness-to-pay
timeFrame: one day
measure: Effectiveness
timeFrame: two days
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute of Cardiology, II Dept. of Coronary Heart Disease
Study officials:
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Mariusz Pytkowski, MD, PhD
role: STUDY_CHAIR
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Michal M Farkowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farkowski MM, Pytkowski M, Maciag A, Golicki D, Wood KA, Kowalik I, Kuteszko R, Szwed H. Gender-related differences in outcomes and resource utilization in patients undergoing radiofrequency ablation of supraventricular tachycardia: results from Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT Study. Europace. 2014 Dec;16(12):1821-7. doi: 10.1093/europace/euu130. Epub 2014 Jun 11.
citation: Farkowski MM, Pytkowski M, Golicki D, Szumowski L, Wood KA, Szwed H. Translation and cultural adaptation of a Patient Perception of Arrhythmia Questionnaire in Poland. Kardiol Pol. 2014;72(3):246-53. doi: 10.5603/KP.a2013.0318. Epub 2013 Dec 2.
citation: Farkowski MM, Pytkowski M, Maciag A, Golicki D, Kowalik I, Czech M, Rucinski P, Szwed H. Patient's age rather than severity of the arrhythmia influences the cost of medical treatment of atrioventricular nodal or atrioventricular reciprocating tachycardia. J Interv Card Electrophysiol. 2016 Nov;47(2):197-202. doi: 10.1007/s10840-016-0167-9. Epub 2016 Aug 3.