CompletedNot Applicable

CS-03 Pressure-Volume Loop Sub-study With RV Lead Positioning

Czechia5 participantsStarted 2016-09-15

Plain-language summary

The position of the RV lead may have an important role in the effectiveness of the Programmable Hypertension Control (PHC) therapy by the Moderato pacemaker eliciting a lag from which RV signals (QRS) are identified. The study attempts to measure RV Pressure and RV Volume with PHC in two RV lead locations.

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 was included in the CS-03 study * Subject indicated for a de novo pulse generator implant Exclusion Criteria: * Subject was excluded from the CS-03 study * Subject is not 100% dependent on RV pacing * Subject receiving a pacemaker pulse generator exchange * Subject is unwilling or cannot provide Informed Consent for this sub 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

Change in the LV volumes (ml)

Timeframe: up to 2 hr

Change in the LV pressures (mmHg)

Timeframe: up to 2 hr

Trial details

NCT IDNCT02909868

SponsorBackBeat Medical Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-13

View on ClinicalTrials.gov More Hypertension trials