Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT (PPRA)

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

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.

Study Overview

• Status: Completed
• Conditions: Tachycardia, Atrioventricular Nodal Reentry; Re-entrant Atrioventricular Tachycardia
• Intervention / Treatment: Procedure: RFA

• Study Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-637
    • Institute of Cardiology, II Dept. of Coronary Heart Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients scheduled for ablation of AVNRT, AVRT or SVT will be eligible for the study.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RFA of AVNRT of AVRT	Procedure: RFA; radiofrequency ablation of slow pathway or accesory pathway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life (HRQOL)	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	two months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utility of health state	Mean score of EQ-5D - a generic questionnaire measuring a health state utility (official Polish translation)	two months
Medical and indirect cost	Cross-sectional data gathered using original questionnaire designed to measure medical and indiresct costs related to arrhythmia incurred during a year preceding RFA	one year
Willingness-to-pay	a cross-sectional willingness-to-pay questionnaire studying hypothetical situation where RFA was not financed by Polish Health Fund	one day
Effectiveness	Data on medical history, final diagnosis, outcome of treatment, safety and future recommendations	two days

Collaborators and Investigators

• Sponsor: Institute of Cardiology, Warsaw, Poland
• Investigators: Principal Investigator: Michal M Farkowski, MD, Institute of Cardiology, Warsaw, Poland; Study Chair: Mariusz Pytkowski, MD, PhD, Institute of Cardiology, Warsaw, Poland

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: May 8, 2012
• First Submitted That Met QC Criteria: May 8, 2012
• First Posted (Estimate): May 9, 2012

Study Record Updates

• Last Update Posted (Estimate): December 15, 2014
• Last Update Submitted That Met QC Criteria: December 12, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: AVNRT; AVRT; WPW
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia, Reciprocating; Tachycardia; Tachycardia, Atrioventricular Nodal Reentry
• Other Study ID Numbers: PPRA