Paroxysmal Supraventricular Tachycardia (PSVT)NCT03353610
The PSVT Place Registry.Paroxysmal Supraventricular Tachycardia (PSVT) Registry.
An observational study of Paroxysmal Supraventricular Tachycardia (PSVT), run by Milestone Pharmaceuticals Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Paroxysmal Supraventricular Tachycardia (PSVT)
- How many people
- 354 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 16 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult male and females, with suspected PSVT as per online prescreening assessment, who are willing to participate in the registry.
Who may be able to join
- 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.
Who cannot join
- Participant does not have an email address.
- Participant does not set up a user account.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- Tachycardia, PSVT episodes
- Medical subject headings
- Tachycardia, Ventricular, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
Measured: Baseline, then every three months for up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start16 Oct 2017
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Why it stopped: Termination due to lack of adequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Supraventricular Tachycardia (PSVT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milestone Pharmaceuticals Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Wight, Study director, Milestone Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353610
- Sponsor's protocol ID
- MSP-2017-1141
- Status last verified
- Dec 2020
- First submitted
- 13 Nov 2017
- Last updated
- 3 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PSVT Place Registry. Paroxysmal Supraventricular Tachycardia (PSVT) Registry: A Web-based, Prospective, Observational Study.
- ClinicalTrials.gov ID
- NCT03353610
- Acronym / sponsor ID
- MSP-2017-1141
- Keywords
- Tachycardia, PSVT episodes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Termination due to lack of adequate enrollment
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Milestone Pharmaceuticals Inc.University, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult male and females, with suspected PSVT as per online prescreening assessment, who are willing to participate in the registry.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Participant does not have an email address.
- Participant does not set up a user account.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Reported Frequency of Recurring PSVT Episodes Using a Patient-Directed Survey Developed by Milestone Pharmaceuticals.
Time frame: Baseline, then every three months for up to 10 years
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.
Patient Reported Duration of Recurring PSVT Episodes Using a Patient-Directed Survey Developed by Milestone Pharmaceuticals.
Time frame: Baseline, then every three months for up to 10 years.
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.
Patient Reported Severity of Recurring PSVT Episodes Using a Patient-Directed Survey Developed by Milestone Pharmaceuticals.
Time frame: Baseline, then every three months for up to 10 years.
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.
2 secondary outcomes
Patient Reported Descriptions of the Symptoms to Characterize Their Recurring PSVT Episodes Using a Patient-Directed Survey Developed by Milestone Pharmaceuticals.
Time frame: 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.
Time frame: Baseline, then every three months for up to 10 years.
Results and safety
The study was stopped early (reason given: Termination due to lack of adequate enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Wight study director
Milestone Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal Supraventricular Tachycardia (PSVT), run by Milestone Pharmaceuticals Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Termination due to lack of adequate enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Frequency of Recurring PSVT Episodes Using a Patient-Directed Survey Developed by Milestone Pharmaceuticals. (time frame: Baseline, then every three months for up to 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.