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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01594814
First Posted: May 9, 2012
Last Update Posted: December 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institute of Cardiology, Warsaw, Poland
  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)

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

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Utility of health state [ Time Frame: two months ]
    Mean score of EQ-5D - a generic questionnaire measuring a health state utility (official Polish translation)

  • 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

  • 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

  • Effectiveness [ Time Frame: two days ]
    Data on medical history, final diagnosis, outcome of treatment, safety and future recommendations


Enrollment: 82
Study Start Date: January 2012
Study Completion Date: November 2014
Primary Completion Date: November 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594814


Locations
Poland
Institute of Cardiology, II Dept. of Coronary Heart Disease
Warsaw, Poland, 02-637
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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT01594814     History of Changes
Other Study ID Numbers: PPRA
First Submitted: May 8, 2012
First Posted: May 9, 2012
Last Update Posted: December 15, 2014
Last Verified: December 2014

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