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Trial record 6 of 136 for:    Recruiting, Not yet recruiting, Available Studies | Tachycardia

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

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ClinicalTrials.gov Identifier: NCT03353610
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Milestone Pharmaceuticals Inc.

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.


Condition or disease
Paroxysmal Supraventricular Tachycardia (PSVT)

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The PSVT Place Registry. Paroxysmal Supraventricular Tachycardia (PSVT) Registry: A Web-based, Prospective, Observational Study.
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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. ]
    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.

  2. 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. ]
    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.


Other Outcome Measures:
  1. Patient Reported Measures of Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression Using the EQ-5D-5L Questionnaire (EuroQol) [ Time Frame: Baseline, then every three months for up to 10 years. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353610


Contacts
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Contact: William C Maier, PhD 1-855-646-3446 PSVTPlaceRegistry@mapigroup.com

Locations
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United States, Kentucky
MAPI Recruiting
Lexington, Kentucky, United States, 40504
Sponsors and Collaborators
Milestone Pharmaceuticals Inc.
Investigators
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Study Director: Douglas Wight Milestone Pharma

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Responsible Party: Milestone Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03353610     History of Changes
Other Study ID Numbers: MSP-2017-1141
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Milestone Pharmaceuticals Inc.:
Tachycardia
PSVT episodes
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes