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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT01594814
First received: May 8, 2012
Last updated: September 24, 2013
Last verified: September 2013

May 8, 2012
September 24, 2013
January 2012
October 2013   (final data collection date for primary outcome measure)
Health-related quality of life (HRQOL) [ Time Frame: two months ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01594814 on ClinicalTrials.gov Archive Site
  • Utility of health state [ Time Frame: two months ] [ Designated as safety issue: No ]
    Mean score of EQ-5D - a generic questionnaire measuring a health state utility (official Polish translation)
  • Medical and indirect cost [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: one day ] [ Designated as safety issue: No ]
    a cross-sectional willingness-to-pay questionnaire studying hypothetical situation where RFA was not financed by Polish Health Fund
  • Effectiveness [ Time Frame: two days ] [ Designated as safety issue: Yes ]
    Data on medical history, final diagnosis, outcome of treatment, safety and future recommendations
Same as current
Not Provided
Not Provided
 
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)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Tachycardia, Atrioventricular Nodal Reentry
  • Re-entrant Atrioventricular Tachycardia
Procedure: RFA
radiofrequency ablation of slow pathway or accesory pathway
RFA of AVNRT of AVRT
Intervention: Procedure: RFA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
December 2013
October 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01594814
PPRA
Yes
Institute of Cardiology, Warsaw, Poland
Institute of Cardiology, Warsaw, Poland
Not Provided
Study Chair: Mariusz Pytkowski, MD, PhD Institute of Cardiology, Warsaw, Poland
Principal Investigator: Michal M Farkowski, MD Institute of Cardiology, Warsaw, Poland
Institute of Cardiology, Warsaw, Poland
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP