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A temporary wire that keeps hearts beating on cue

NCT ID NCT07820072

Disease control Sponsor: FIAB SpA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

Researchers are studying the SPIKE FLOW endocardial lead, a temporary wire placed inside the heart to keep it beating during surgery or while doctors check a slow heart rhythm. The study enrolls 131 adults who need short-term cardiac pacing. Doctors implant the lead, measure how well it captures the heartbeat and senses natural heart signals, then remove it and follow participants for 30 days to track safety.

What this could mean

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

Active substance
SPIKE FLOW endocardial lead, a temporary heart pacing wire
What this could lead to
If the lead performs well, it could give doctors a reliable option for temporary pacing during surgery or while they work out whether a slow heart rhythm is short-lived or permanent.
What could go wrong
This is a single-arm study with no comparison group, so it cannot prove the lead is better than other options. Temporary pacing leads can shift, fail to capture the heartbeat, or cause bleeding or infection, and the study runs at a small number of sites in Italy.

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

About 131 people

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

Started

Aug 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

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 undergoing a surgical or an interventional procedure, requiring temporary cardiac pacing per investigator's medical judgment or subjects with bradycardia who are under evaluation to determine if the cause is transient or permanent; * Subject is at least 18 years of age; * Subject provides written informed consent to the study. Exclusion Criteria: * Subject has a co-existing temporary pacing or an implanted active permanent pacemaker or a cardiac defibrillator; * Subject in cardiogenic shock; * Subject is currently in atrial fibrillation; * Subject is pregnant or breastfeeding; * Subject had a stroke within 6 months prior to enrollment; * Subject has renal insufficiency with creatinine \>2 mg/dl; * Subject with known bleeding diathesis; * Subject with a history of deep vein thrombosis or pulmonary embolism within 6 months; * Subject with known tricuspid valve disease that may impede catheter advancement to and withdrawal from the right ventricle; * Subject with known intracardiac thrombus or vegetation on echocardiography; * Subject with significant neck abnormalities such that placement of a right and/or left internal jugular vein line would be difficult; * Subject has an active systemic infection or local infection at or around the insertion site; * Subject is involved in another clinical study that could influence the safety or outcome measures of this study.

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Conditions

The condition(s) this trial relates to.

acute myocardial infarction atrioventricular block Bradycardia cardiac arrest ventricular tachycardia

As listed by the trial registrant

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

Acute myocardial infarction (AMI) Asystole Av block Bradycardia The objective of this study is to assess the safety and performance of the spike flow endocardial lead Ventricular tachyarrhythmia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, Pisa, 56126, Italy

  • Ospedale Generale Regionale "F. Miulli"

    NOT_YET_RECRUITING

    Acquaviva delle Fonti, Bari, 70021, Italy

  • Ospedale del Cuore 'G. Pasquinucci' Fondazione Toscana 'Gabriele Monasterio'

    NOT_YET_RECRUITING

    Massa, Massa-Carrara, 54100, Italy

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