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Pacemaker lead position may unlock better blood pressure control

NCT ID NCT02909868

Knowledge-focused Sponsor: BackBeat Medical Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether the position of a pacemaker lead in the right ventricle can improve how well the BackBeat Moderato system controls blood pressure. Five people with hypertension who already have a pacemaker will have their heart pressures and volumes measured with the therapy on and off. The goal is to understand which lead location works best, which could lead to more effective blood pressure management.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BackBeat Moderato pacemaker with Programmable Hypertension Control (PHC) therapy
What this could lead to
If successful, this could help refine pacemaker placement to better control blood pressure in people with hypertension.
What could go wrong
This is a very small sub-study with only 5 participants, so results may not apply to everyone. It is designed to gather data, not to prove a treatment works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

5 people

The number who actually took part.

Started

Sep 2016

Finished

May 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hypertensive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension

Contacts and locations

Locations

  • Na Homolce Hospital

    Prague, Czechia

More trials for these conditions

Other studies related to the condition(s) this trial covers.