The PSVT Place Registry.Paroxysmal Supraventricular Tachycardia (PSVT) Registry.

The PSVT Place Registry. Paroxysmal Supraventricular Tachycardia (PSVT) Registry: A Web-based, Prospective, Observational Study.

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.

Study Overview

• Status: Terminated
• Conditions: Paroxysmal Supraventricular Tachycardia (PSVT)

• Study Type: Observational
• Enrollment (Actual): 354

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • MAPI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult male and females, with suspected PSVT as per online prescreening assessment, who are willing to participate in the registry.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

• Participant does not have an email address.
• Participant does not set up a user account.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Descriptions of the Symptoms to Characterize Their Recurring PSVT Episodes Using a Patient-Directed Survey Developed by Milestone Pharmaceuticals.	The patient is able to report the most common symptoms that they use to describe each of their recurring PSVT episodes. Changes in PSVT episode symptoms over time will also be assessed.	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.	The patient is able to report physician visits, emergency room visits, hospital admissions, surgical interventions, medication use, monitoring device use, and patient self-management techniques, which are used to assess health resource utilization for each of their recurring PSVT episodes.	Baseline, then every three months for up to 10 years.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Measures of Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression Using the EQ-5D-5L Questionnaire (EuroQol)	The patient is able to report measures of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression at routine intervals. Changes in EQ-5D-5L scores over time will also be assessed.	Baseline, then every three months for up to 10 years.

Collaborators and Investigators

• Sponsor: Milestone Pharmaceuticals Inc.
• Investigators: Study Director: Douglas Wight, Milestone Pharma

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): March 16, 2020

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Tachycardia; PSVT episodes
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular; Tachycardia, Supraventricular
• Other Study ID Numbers: MSP-2017-1141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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.

• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No