Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT

Completed

• Conditions: Re-entrant Atrioventricular Tachycardia; Tachycardia, Atrioventricular Nodal Reentry
• Interventions: Procedure: RFA

• Registration Number: NCT01594814
• Lead Sponsor: National Institute of Cardiology, Warsaw, Poland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-09
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-12
• Last Update Posted: 2014-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RFA of AVNRT of AVRT	RFA	-

Primary Outcome Measures

Name	Time	Method
Health-related quality of life (HRQOL)	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

Secondary Outcome Measures

Name	Time	Method
Effectiveness	two days	Data on medical history, final diagnosis, outcome of treatment, safety and future recommendations
Utility of health state	two months	Mean score of EQ-5D - a generic questionnaire measuring a health state utility (official Polish translation)
Medical and indirect cost	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	one day	a cross-sectional willingness-to-pay questionnaire studying hypothetical situation where RFA was not financed by Polish Health Fund

Trial Locations

Locations (1)

Institute of Cardiology, II Dept. of Coronary Heart Disease; 🇵🇱 Warsaw, Poland