Tachycardia, Atrioventricular Nodal ReentryPPRANCT01594814
Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT
An observational study of Tachycardia, Atrioventricular Nodal Reentry and Re-entrant Atrioventricular Tachycardia, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Atrioventricular Nodal Reentry, Re-entrant Atrioventricular Tachycardia
- What is being tested?
- RFA
- Type of treatment
- Surgery or procedure
- How many people
- 82 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2012to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients scheduled for ablation of AVNRT, AVRT or SVT will be eligible for the study.
Who may be able to join
- Written informed consent
- Age above 18
- Scheduled RFA due to AVNRT or AVRT
- Sufficient knowledge of the Polish language to independently complete the questionnaires
Who cannot join
- No written informed consent
- Health states significantly impairing QoL (eg. stroke, advanced heart failure)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Institute of Cardiology, II Dept. of Coronary Heart Disease
Warsaw, 02-637
About this study
Official title: 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.
Read more
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.
- Being tested
- RFA
- Keywords
- AVNRT, AVRT, WPW
- Medical subject headings
- Tachycardia, Atrioventricular Nodal Reentry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFAProcedure or surgery
radiofrequency ablation of slow pathway or accesory pathway
| Study group | Role | What they receive |
|---|---|---|
| RFA of AVNRT of AVRT | Not described Receives: Procedure: RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two months
Secondary outcomes (4)
Utility of health state
Mean score of EQ-5D - a generic questionnaire measuring a health state utility (official Polish translation)
Measured: two months
Medical and indirect cost
Cross-sectional data gathered using original questionnaire designed to measure medical and indiresct costs related to arrhythmia incurred during a year preceding RFA
Measured: one year
Willingness-to-pay
a cross-sectional willingness-to-pay questionnaire studying hypothetical situation where RFA was not financed by Polish Health Fund
Measured: one day
Effectiveness
Data on medical history, final diagnosis, outcome of treatment, safety and future recommendations
Measured: two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tachycardia, Atrioventricular Nodal ReentryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariusz Pytkowski, MD, PhD, Study chair, National Institute of Cardiology, Warsaw, PolandMichal M Farkowski, MD, Principal investigator, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594814
- Sponsor's protocol ID
- PPRA
- Acronym
- PPRA
- Status last verified
- Dec 2014
- First submitted
- 8 May 2012
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24919538Farkowski 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.
PubMed 24293142Farkowski 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.
PubMed 27488509
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT - a Quality of Life, Utility and Willingness to Pay Study (PPRA Study)
- ClinicalTrials.gov ID
- NCT01594814
- Acronym / sponsor ID
- PPRA / PPRA
- Keywords
- AVNRT, AVRT, WPW
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RFA of AVNRT of AVRT | – | Procedure: RFA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for ablation of AVNRT, AVRT or SVT will be eligible for the study.
Key inclusion criteria (4 listed)
- Written informed consent
- Age above 18
- Scheduled RFA due to AVNRT or AVRT
- Sufficient knowledge of the Polish language to independently complete the questionnaires
Key exclusion criteria (2 listed)
- No written informed consent
- Health states significantly impairing QoL (eg. stroke, advanced heart failure)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RFAradiofrequency ablation of slow pathway or accesory pathway | Procedure or surgery | RFA of AVNRT of AVRT |
Primary outcome
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
4 secondary outcomes
Utility of health state
Time frame: two months
Medical and indirect cost
Time frame: one year
Willingness-to-pay
Time frame: one day
Effectiveness
Time frame: two days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
- Results publication: PubMed 24919538Farkowski 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.
- Results publication: PubMed 24293142Farkowski 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.
- Derived from this study: PubMed 27488509Farkowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariusz Pytkowski, MD, PhD study chair
National Institute of Cardiology, Warsaw, Poland
Michal M Farkowski, MD principal investigator
National Institute of Cardiology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tachycardia, Atrioventricular Nodal Reentry and Re-entrant Atrioventricular Tachycardia, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (HRQOL) (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01594814, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2014.