CompletedNot Applicable

TD01 Master Study (Safety and Efficacy Study)

Austria, Germany30 participantsStarted 2014-08

Plain-language summary

This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Meet standard indication for ICD/CRT-D therapy * First ICD/CRT-D implantation or upgrade from pacemaker * Duly signed informed consent form * Willing to participate for the whole study duration * Patient accepts Home Monitoring concept and is able to activate and use the CardioMessenger * Patient has a legal capacity and ability to consent Exclusion Criteria: * Meet a standard contraindication for an ICD/CRT-D therapy * Age \< 18 years * Pregnant or breast-feeding * Cardiac surgery planned within the next six months * Enrollment in another cardiac clinical investigation with active treatment arm * Mechanical tricuspid valve prosthesis or severe tricuspid valve disease * Known dexamethasone acetate intolerance

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

TD01 Pacing Threshold

Timeframe: 3 month follow-up

TD01 Sensing Amplitude

Timeframe: 3 month follow-up

Trial details

NCT IDNCT02087189

SponsorBiotronik SE & Co. KG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-12

Results submitted2021-06-14

View on ClinicalTrials.gov More ICD/CRT-D Indication trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.