Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT

Tachycardia, Atrioventricular Nodal Reentry Clinical Trial

— PPRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594814
• Other study ID #: PPRA
• Status: Completed
• Phase: N/A
• First received: May 8, 2012
• Last updated: December 12, 2014
• Start date: January 2012
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Re-entrant Atrioventricular Tachycardia
• Tachycardia
• Tachycardia, Atrioventricular Nodal Reentry
• Tachycardia, Supraventricular

Intervention

Procedure:
• RFA
radiofrequency ablation of slow pathway or accesory pathway

Locations

Country	Name	City	State
Poland	Institute of Cardiology, II Dept. of Coronary Heart Disease	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (2)

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. — View 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' — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Utility of health state	Mean score of EQ-5D - a generic questionnaire measuring a health state utility (official Polish translation)	two months	No
Secondary	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	No
Secondary	Willingness-to-pay	a cross-sectional willingness-to-pay questionnaire studying hypothetical situation where RFA was not financed by Polish Health Fund	one day	No
Secondary	Effectiveness	Data on medical history, final diagnosis, outcome of treatment, safety and future recommendations	two days	Yes