Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study
This study is completed. It focuses on bipolarity and currently lists study information in Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, the Netherlands, Serbia and Montenegro, Spain, Sweden, Switzerland, and the United States.
Key information made simple
What is this study testing?
This study is testing whether a digital tool or app may be useful for people experiencing bipolarity.
What would participation involve?
Participants may use a digital tool or app, complete questionnaires or follow-up assessments, attend study visits with the research team. The registry lists locations in Australia, Austria, Belgium.
Who is it mainly for?
This study appears to be mainly for people with bipolarity.
What should you check before joining?
Ask about whether participation can be remote and what device access is needed, whether there is a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.
Your next step
The official record suggests in-person participation through a research setting, with sites including Alaska Heart Institute in Anchorage. Participation appears to center on questionnaires, assessments, or follow-up information rather than a study treatment. The main fit is usually being able to understand the study and consent and being able to follow the planned visits or tasks, while common reasons not to take part include other factors that could make participation unsuitable. The official record does not list a trial phase, which usually means the study is focused on observation rather than testing a staged treatment.
Questions to ask before joining
- What are the exact eligibility criteria, and what could exclude someone?
- How many visits, assessments, or follow-ups are expected, and over what period?
- What risks, side effects, practical burdens, or alternatives should be understood first?
- Who should be contacted to confirm locations, timing, compensation, and next steps?
Things to check before joining
- Recruitment status
- Completed
- Estimated enrollment
- Not clearly listed
- Sponsor
- Medtronic
- Sponsor type
- Unknown or unclear
- Study type
- Other
- Intervention type
- Other / unclear
- Study phase
- Not clearly listed
- Locations
- United States, Australia, France, ...
- Age range
- Not clearly listed
- Official registry ID
- NCT01076361
- Official title
- Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study
- Official source
- Official registry link
Want help reviewing this study?
For you
Taking part may help improve understanding of your condition.
It requires regular visits and structured follow-up.
Requires travel, with in-person participation in Australia.
Not medical advice
Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com
Questions about this study
What is this study trying to understand?
This study is exploring digital app or tool for people with bipolarity. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.
Why is the study type not clearly categorized?
The study type is not clearly categorized in the public registry. Focus on the objective, required tasks, visits, any intervention, and eligibility criteria, then ask the study team to confirm.
Who might this study be for?
This study may concern people with bipolarity. The criteria appear fairly broad, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.
What would I likely need to do?
The public registry does not clearly describe all participation steps. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.
What risks or points should I check?
The public registry does not make the main risk category clear. Ask the study team what activities are required, what could feel uncomfortable, how safety is monitored, and what happens if you want to stop. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.
Will I need to travel or attend in-person visits?
The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.
Who is behind this study?
This study is sponsored by Medtronic, which appears to be unknown or unclear. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.
Can I still join this study?
The registry indicates that this study is completed. It may still be useful for understanding the research, but you are unlikely to be able to join.
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