Clinical trial NCT03353610: The PSVT Place Registry.Paroxysmal Supraventricular Tachycardia (PSVT) Registry.
Official title: The PSVT Place Registry. Paroxysmal Supraventricular Tachycardia (PSVT) Registry: A Web-based, Prospective, Observational Study.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Paroxysmal Supraventricular Tachycardia (PSVT)
Keywords: Tachycardia
PSVT episodes
Lead sponsor: Milestone Pharmaceuticals Inc.
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 354
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient Reported Frequency of Recurring PSVT Episodes Using a Patient-Directed Survey Developed by Milestone Pharmaceuticals.
timeFrame: Baseline, then every three months for up to 10 years
measure: Patient Reported Duration of Recurring PSVT Episodes Using a Patient-Directed Survey Developed by Milestone Pharmaceuticals.
timeFrame: Baseline, then every three months for up to 10 years.
measure: Patient Reported Severity of Recurring PSVT Episodes Using a Patient-Directed Survey Developed by Milestone Pharmaceuticals.
timeFrame: Baseline, then every three months for up to 10 years.
Secondary outcomes:
measure: Patient Reported Descriptions of the Symptoms to Characterize Their Recurring PSVT Episodes Using a Patient-Directed Survey Developed by Milestone Pharmaceuticals.
timeFrame: Baseline, then every three months for up to 10 years.
measure: Patient Reported Descriptions of Health Resource Utilization to Manage Their Recurring PSVT Episodes Using a Patient-Directed Survey Developed by Milestone Pharmaceuticals.
timeFrame: Baseline, then every three months for up to 10 years.
Other outcomes:
measure: Patient Reported Measures of Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression Using the EQ-5D-5L Questionnaire (EuroQol)
timeFrame: Baseline, then every three months for up to 10 years.
Locations:
city: Lexington
country: United States
facility: MAPI
state: Kentucky
Study officials:
affiliation: Milestone Pharma
name: Douglas Wight
role: STUDY_DIRECTOR
References: