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A thin wire in the Heart's wiring: registry tracks a new pacing lead

NCT ID NCT07808554

Disease control Sponsor: Hospital SOS Cardio Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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)

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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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers in Brazil are following 300 adults who need a permanent pacemaker and whose doctors chose the Solia CSP S lead, a thin wire threaded into the heart's conduction system. The study observes routine care at up to 10 electrophysiology centers for 24 months, checking whether the lead keeps working, maintains capture, and avoids dislodgement or serious complications. It is an observational registry, so it describes real-world performance rather than comparing the lead against another treatment.

What this could mean

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

Active substance
Solia CSP S pacing lead, a thin wire placed in the heart's conduction system to deliver pacing
What this could lead to
If the lead performs well over two years, doctors could gain clearer real-world evidence for using conduction system pacing in people who need a permanent pacemaker.
What could go wrong
This is an observational registry, not a randomized trial, so it cannot prove the lead is better than other options. Lead dislodgement, rising electrical thresholds, or loss of capture could still occur, and results from Brazilian centers may not apply everywhere.

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.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Who is studied

Adult patients with a clinical indication for permanent ventricular pacing in whom the treating physician, based on routine clinical practice and independently of study participation, has decided to attempt conduction system pacing using the Solia CSP lead, preferably in the left bundle branch area. Participants will be consecutively enrolled at up to 10 electrophysiology centers in Brazil and followed for up to 24 months.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: \- Age ≥18 years. Clinical indication for a cardiac implantable electronic device requiring permanent ventricular pacing, according to contemporary guidelines. Treating physician's clinical decision to use the Solia CSP lead for conduction system pacing, preferably LBBAP. Planned implantation of a BIOTRONIK device with remote monitoring capability. Ability to comply with the study follow-up schedule for up to 24 months. Written informed consent. Exclusion Criteria: Exclusion Criteria: Inability to provide written informed consent. Active systemic infection or local infection at the implantation site. Life expectancy \<24 months due to a non-cardiovascular condition. Inability to comply with remote monitoring requirements. Participation in another cardiovascular device study with conflicting objectives or endpoints. Previous implantation of a CSP lead at the same anatomical site. Emergency procedure preventing standardized collection of baseline variables. Pregnancy or breastfeeding in women of childbearing potential.

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As listed by the trial registrant

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

Left bundle branch area pacing

How to take part

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  1. The official record

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