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

This study is currently recruiting participants.
Verified April 2013 by Institute of Cardiology, Warsaw, Poland
Sponsor:
Information provided by (Responsible Party):
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT01594814
First received: May 8, 2012
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Tachycardia, Atrioventricular Nodal Reentry
Re-entrant Atrioventricular Tachycardia
 Procedure: RFA

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT - a Quality of Life, Utility and Willingness to Pay Study (PPRA Study)

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 150
Study Start Date: January 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
RFA of AVNRT of AVRT Procedure: RFA
radiofrequency ablation of slow pathway or accesory pathway

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594814

Contacts
Contact: Michal M Farkowski, MD 022 343 40 50 ext +48 mfarkowski@gmail.com
Contact: Mariusz Pytkowski, MD, PhD 022 343 40 50 ext +48 mpytkowski@ikard.pl

Locations
Poland
Institute of Cardiology, II Dept. of Coronary Heart Disease Recruiting
Warsaw, Poland, 02-637
Contact: Michal M Farkowski, MD     022 343 4050 ext +48     mfarkowski@gmail.com    
Principal Investigator: Michal M Farkowski, MD            
Institute of Cardiology, Arrhythmia Dept. Recruiting
Warsaw, Poland, 04-628
Contact: Michal Orczykowski, MD, PhD     022 343 44 17 ext +48     morczykowski@gazeta.pl    
Principal Investigator: Michal Orczykowski, MD, PhD            
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Investigators
Study Chair: Mariusz Pytkowski, MD, PhD Institute of Cardiology, Warsaw, Poland
Principal Investigator: Michal M Farkowski, MD Institute of Cardiology, Warsaw, Poland
  More Information

No publications provided

Responsible Party: Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT01594814     History of Changes
Other Study ID Numbers: PPRA
Study First Received: May 8, 2012
Last Updated: April 12, 2013
Health Authority: Poland: Ethics Committee

Keywords provided by Institute of Cardiology, Warsaw, Poland:
AVNRT
AVRT
WPW

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Atrioventricular Nodal Reentry
Tachycardia, Supraventricular
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Tachycardia, Reciprocating

ClinicalTrials.gov processed this record on May 21, 2013