Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT

NCT01594814 | Completed DMC

• 1 other identifier: PPRA
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Tachycardia, Atrioventricular Nodal Reentry; Re-entrant Atrioventricular Tachycardia

Keywords

AVNRT; AVRT; WPW

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life (HRQOL)

  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

  two months

Secondary Outcomes (4)

• Utility of health state

  two months

• Medical and indirect cost

  one year

• Willingness-to-pay

  one day

• Effectiveness

  two days

Study Arms (1)

RFA of AVNRT of AVRT

Procedure: RFA

Interventions

RFA PROCEDURE

radiofrequency ablation of slow pathway or accesory pathway

RFA of AVNRT of AVRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead

Study Sites (1)

Institute of Cardiology, II Dept. of Coronary Heart Disease

Warsaw, 02-637, Poland

Location

Related Publications (3)

• Farkowski MM, Pytkowski M, Maciag A, Golicki D, Wood KA, Kowalik I, Kuteszko R, Szwed H. Gender-related differences in outcomes and resource utilization in patients undergoing radiofrequency ablation of supraventricular tachycardia: results from Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT Study. Europace. 2014 Dec;16(12):1821-7. doi: 10.1093/europace/euu130. Epub 2014 Jun 11.

  PMID: 24919538 RESULT

• Farkowski MM, Pytkowski M, Golicki D, Szumowski L, Wood KA, Szwed H. Translation and cultural adaptation of a Patient Perception of Arrhythmia Questionnaire in Poland. Kardiol Pol. 2014;72(3):246-53. doi: 10.5603/KP.a2013.0318. Epub 2013 Dec 2.

  PMID: 24293142 RESULT

• Farkowski MM, Pytkowski M, Maciag A, Golicki D, Kowalik I, Czech M, Rucinski P, Szwed H. Patient's age rather than severity of the arrhythmia influences the cost of medical treatment of atrioventricular nodal or atrioventricular reciprocating tachycardia. J Interv Card Electrophysiol. 2016 Nov;47(2):197-202. doi: 10.1007/s10840-016-0167-9. Epub 2016 Aug 3.

  PMID: 27488509 DERIVED

MeSH Terms

Conditions

Tachycardia, Atrioventricular Nodal Reentry

Condition Hierarchy (Ancestors)

Tachycardia, Reciprocating; Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mariusz Pytkowski, MD, PhD

  National Institute of Cardiology, Warsaw, Poland

  STUDY CHAIR

• Michal M Farkowski, MD

  National Institute of Cardiology, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 9, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 15, 2014

Record last verified: 2014-12

Locations

PL (1)