CompletedNot Applicable

Imaging Study of Lead Implant for His Bundle Pacing

United States70 participantsStarted 2017-11-29

Plain-language summary

The purpose of this research study is to assess the implant success proportion of the Medtronic SelectSecure MRI SureScan Model 3830 pacing lead at the bundle of His for His bundle pacing.

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: * Subject has a Class I or II indication for implantation of an implantable pacemaker * Subject (or legally authorized representative) has signed and dated the study-specific Consent Form * Subject is 18 years of age or older, or is of legal age to give informed consent per local and national law * Subject is expected to remain available for follow-up visits Exclusion Criteria: * Subject is contraindicated for Cardiac CT * Subject has an existing or prior pacemaker, ICD or CRT device implant * Subject is intended to receive an implant of a LV lead or CRT device * Subject life expectancy is less than 1 year * Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence * Subjects with exclusion criteria required by local law (e.g. age or other) * Subject with a medical condition that precludes the patient from participation in the opinion of the investigator * Subject is enrolled in a concurrent study that may confound the results of this study.

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

Implant Success

Timeframe: Day of implant

Trial details

NCT IDNCT03294317

SponsorMedtronic Cardiac Rhythm and Heart Failure

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-04-24

Results submitted2021-04-13

View on ClinicalTrials.gov More Cardiac Pacemaker, Artificial 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.