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

Paroxysmal Supraventricular Tachycardia (PSVT) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03353610
• Other study ID #: MSP-2017-1141
• Status: Terminated
• Start date: October 16, 2017
• Est. completion date: March 16, 2020

Study information

• Verified date: December 2020
• Source: Milestone Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 354
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Paroxysmal Supraventricular Tachycardia (PSVT)
• Tachycardia
• Tachycardia, Supraventricular

Locations

Country	Name	City	State
United States	MAPI	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Milestone Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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
Primary	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.
Primary	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	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.
Secondary	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.