CompletedNCT01076361

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.

BipolarityOther

In plain English

Key information made simple

This study exists to understand how a digital app or remote support tool holds up over time after the earliest research stage. Researchers are trying to understand how people respond to a digital app or remote support tool in practice and what may need to be adjusted. For people living with Bipolarity, the gap between what sounds good on paper and what works in daily life is often important. If the findings are useful, they could help future care become more targeted, practical, and easier to trust. Taking part helps build the evidence that can improve understanding and care for others over time.

What to expect

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.

Official source

Registry reference

This page links back to the public source record so people can verify details directly with the registry and research team.

If you want the full study description, eligibility criteria, locations, and sponsor information in the original format, this is the place to check before taking the next step.

Open source record

Need help deciding?

Ask HopeStage to review this study with me

This form records your interest so HopeStage can follow up with practical guidance. It is not a medical eligibility decision and it does not guarantee a study spot.

Study reference: NCT01076361. We only ask for your email here. HopeStage can help you review the study, but this is not a medical eligibility decision.

In practice

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.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

Study clarity

Things to check before joining

Sponsor: Medtronic
Sponsor type: Unknown or unclear
Main activity: digital app or tool
Time commitment: long follow-up or multiple visits
Study phase: Not available
Enrollment: Not available
Recruitment status: Completed
Source: Official registry link

FAQ

Questions about this study

What is Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study?

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.

Who is behind this study, and what type of sponsor is it?

This study is sponsored by Medtronic. We could not clearly classify the sponsor type from the available data. Check the official source record to verify who is responsible for the study.

What does participation involve, what phase is it, and what should I ask about safety?

This study may involve digital app or tool, study visits, and assessments. The time commitment is long follow-up or multiple visits. The study phase is not available in HopeStage data. Check the official source record to see whether a phase is listed. Enrollment is not available in HopeStage data. HopeStage cannot say whether a study is safe or right for you. Before joining, ask the research team about possible risks, time commitment, visits, side effects, compensation, safety monitoring, and whether participation may affect your current care.

Where can I verify the study details?

Use the official source record linked on this page to check the full study description, recruitment status, eligibility criteria, locations, sponsor information, phase, enrollment, contact details, and any listed risks or requirements.