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Completed

NCT Number: NCT01594814

Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT

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.

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Key information

Conditions

Tachycardia, Atrioventricular Nodal Reentry Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Re-entrant Atrioventricular Tachycardia Tachycardia Tachycardia, Reciprocating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Cardiology, II Dept. of Coronary Heart Disease

Warsaw, 02-637, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Age above 18
  • Scheduled RFA due to AVNRT or AVRT
  • Sufficient knowledge of the Polish language to independently complete the questionnaires

Exclusion criteria

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

Treatment and study plan

RFA

Procedure

radiofrequency ablation of slow pathway or accesory pathway

Primary outcomes

  1. Health-related quality of life (HRQOL)

    Time frame: 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 outcomes

  1. Utility of health state

    Time frame: two months

    Mean score of EQ-5D - a generic questionnaire measuring a health state utility (official Polish translation)

  2. Medical and indirect cost

    Time frame: 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

  3. Willingness-to-pay

    Time frame: one day

    a cross-sectional willingness-to-pay questionnaire studying hypothetical situation where RFA was not financed by Polish Health Fund

  4. Effectiveness

    Time frame: two days

    Data on medical history, final diagnosis, outcome of treatment, safety and future recommendations

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Warsaw, Poland

Other

Registry information

Official study title

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

Acronym: PPRA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 9, 2012
Registry last updated
Dec 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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