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Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT

Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT - a Quality of Life, Utility and Willingness to Pay Study (PPRA Study)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01594814
Acronym
PPRA
Enrollment
82
Registered
2012-05-09
Start date
2012-01-31
Completion date
2014-11-30
Last updated
2014-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Re-entrant Atrioventricular Tachycardia, Tachycardia, Atrioventricular Nodal Reentry

Keywords

AVNRT, AVRT, WPW

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.

Interventions

PROCEDURERFA

radiofrequency ablation of slow pathway or accesory pathway

Sponsors

National Institute of Cardiology, Warsaw, Poland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Health-related quality of life (HRQOL)two monthsMean 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

Secondary

MeasureTime frameDescription
Utility of health statetwo monthsMean score of EQ-5D - a generic questionnaire measuring a health state utility (official Polish translation)
Medical and indirect costone yearCross-sectional data gathered using original questionnaire designed to measure medical and indiresct costs related to arrhythmia incurred during a year preceding RFA
Willingness-to-payone daya cross-sectional willingness-to-pay questionnaire studying hypothetical situation where RFA was not financed by Polish Health Fund
Effectivenesstwo daysData on medical history, final diagnosis, outcome of treatment, safety and future recommendations

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026