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

NCT ID: NCT03353610

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

354 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-16

Study Completion Date

2020-03-16

Brief Summary

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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.

Detailed Description

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Conditions

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Paroxysmal Supraventricular Tachycardia (PSVT)

Keywords

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Tachycardia PSVT episodes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient-reported PSVT.

Participants who recorded a PSVT diagnosis.

No interventions assigned to this group

Suspected PSVT.

Participants who do not record a PSVT diagnosis.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Milestone Pharmaceuticals Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Douglas Wight

Role: STUDY_DIRECTOR

Milestone Pharma

Locations

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MAPI

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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MSP-2017-1141

Identifier Type: -

Identifier Source: org_study_id