Study Stopped
Termination due to lack of adequate enrollment
The PSVT Place Registry.Paroxysmal Supraventricular Tachycardia (PSVT) Registry.
The PSVT Place Registry. Paroxysmal Supraventricular Tachycardia (PSVT) Registry: A Web-based, Prospective, Observational Study.
1 other identifier
observational
354
1 country
1
Brief Summary
Paroxysmal supraventricular tachycardia (PSVT) is a sporadic, sudden, and recurring tachycardia that is caused by an altered electrical conductivity in the heart. It causes palpitations and a rapid heart rate, which may induce fear in the patient and negatively impact the patient's quality of life. Therefore, most patients experience not only physical symptoms of PSVT, but also dramatic psychological burdens. As PSVT drug development efforts advance, it has become increasingly important to document the impact of PSVT in a systematic way, in terms of the disease natural history and clinical characteristics of PSVT episodes, as well as the psychological impact of the condition as reported by patients over time. In order to meet the needs for ongoing, systematic data collection on PSVT, a multinational registry, The PSVT Place Registry (www.PSVTPlaceRegistry.com), is being implemented and will be initially comprised of data entered directly by patients. The long-term registry is designed with a participant-focused approach to enable continuity of data collection and minimization of impact from changes of participants' health care providers. The registry may be expanded at a later time to include physician-reported data. The information from the registry is planned to be a resource for participants with PSVT, their families and support networks, their doctors, and the research community to better understand PSVT-related symptoms and awareness, PSVT diagnoses, patient self-management, medical treatments for PSVT, and impact of PSVT on quality of life from the patient perspective.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2017
CompletedFirst Submitted
Initial submission to the registry
November 13, 2017
CompletedFirst Posted
Study publicly available on registry
November 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2020
CompletedDecember 3, 2020
December 1, 2020
2.4 years
November 13, 2017
December 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Patient Reported Frequency of Recurring PSVT Episodes Using a Patient-Directed Survey Developed by Milestone Pharmaceuticals.
The patient is able to report the frequency (number of PSVT episodes per day, week, month, etc.) for each of their recurring PSVT episodes. Changes in PSVT episode frequency over time will also be assessed.
Baseline, then every three months for up to 10 years
Patient Reported Duration of Recurring PSVT Episodes Using a Patient-Directed Survey Developed by Milestone Pharmaceuticals.
The patient is able to report the duration (seconds, minutes, hours, etc.) for each of their recurring PSVT episodes. Changes in PSVT episode duration over time will also be assessed.
Baseline, then every three months for up to 10 years.
Patient Reported Severity of Recurring PSVT Episodes Using a Patient-Directed Survey Developed by Milestone Pharmaceuticals.
The patient is able to report the severity (1, not severe at all - 5, extremely severe) for each of their recurring PSVT episodes. Changes in PSVT episode severity over time will also be assessed.
Baseline, then every three months for up to 10 years.
Secondary Outcomes (2)
Patient Reported Descriptions of the Symptoms to Characterize Their Recurring PSVT Episodes Using a Patient-Directed Survey Developed by Milestone Pharmaceuticals.
Baseline, then every three months for up to 10 years.
Patient Reported Descriptions of Health Resource Utilization to Manage Their Recurring PSVT Episodes Using a Patient-Directed Survey Developed by Milestone Pharmaceuticals.
Baseline, then every three months for up to 10 years.
Other Outcomes (1)
Patient Reported Measures of Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression Using the EQ-5D-5L Questionnaire (EuroQol)
Baseline, then every three months for up to 10 years.
Study Arms (3)
Patient-reported PSVT.
Participants who recorded a PSVT diagnosis.
Suspected PSVT.
Participants who do not record a PSVT diagnosis.
Other subgroups.
Subgroups also may be examined ( PSVT-episode characteristics, use of a self-management technique for PSVT at home (on their own) to return heart rate back to normal).The sample size, however, may limit the extent of any subgroup analyses.
Eligibility Criteria
Adult male and females, with suspected PSVT as per online prescreening assessment, who are willing to participate in the registry.
You may qualify if:
- A participant must meet all of the following criteria to be eligible for participation in the study:
- Adult male or female.
- Participant has suspected PSVT as per the online prescreening assessment.
- Participant lives in a country in which the registry is being conducted.
- Participant has signed the informed consent form indicating he/she is able to complete the online registry data collection forms on his/her own.
You may not qualify if:
- Participant does not have an email address.
- Participant does not set up a user account.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MAPI
Lexington, Kentucky, 40504, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Douglas Wight
Milestone Pharma
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2017
First Posted
November 27, 2017
Study Start
October 16, 2017
Primary Completion
March 16, 2020
Study Completion
March 16, 2020
Last Updated
December 3, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- The Sponsor and/or designee will submit final study results to the appropriate regulatory authorities, no later than 1 year after closure of the registry by the Sponsor.
The details of the processes of producing and reviewing reports, manuscripts, and presentations based on the data from this registry are described in the registry's publication guidelines. The Sponsor and/or designee will prepare periodic summaries of descriptive analyses of the data collected in the registry, as required by the appropriate regulatory authority such as disposition data, summary demographic, clinical, or quality of life data. Since enrollment in the registry is from the general population and may be variable, and there is no planned end date for data collection, there is no pre-specified timeline established for preparation of the data summaries. Thus data may be summarized when there is a sufficient length of data for a sufficient amount of participants to constitute a valuable data presentation. In addition, data may be summarized periodically for presentation at professional conferences and sessions, as appropriate.