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New Dual-Energy catheter aims to stop deadly heart rhythms

NCT ID NCT06816368

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new catheter that uses two types of energy (radiofrequency and pulsed field) to destroy the tiny areas of heart tissue causing ventricular tachycardia, a fast and dangerous heart rhythm. Thirty patients with recurrent episodes will undergo the procedure. The goal is to see if the new technology can safely eliminate the abnormal rhythms during the procedure and prevent them from coming back for at least six months.

What this could mean

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

Active substance
catheter ablation using radiofrequency and pulsed field energy
What this could lead to
If successful, this could offer a more effective and safer way to control ventricular tachycardia, reducing the need for repeated procedures.
What could go wrong
This is a small, early-stage study with only 30 participants, so results may not apply to everyone. There are risks of complications like bleeding or heart damage from the ablation.

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 30 people

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

Started

Jul 2025

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: 1. Patients with two or more documented spontaneous episodes of sustained symptomatic VT within 3 months or 1 sustained episode of VT or VT storm (two or more VTs in 24 hours) which required device therapy (shock or anti-tachycardia pacing), external cardioversion, escalated antiarrhythmic therapy, and / or hospitalization * Documented episodes assessment will be performed by a review of ECGs, hospitalization records, and/or Implantable Cardioverter Defibrillator (ICD) interrogation * Patients must have an ICD implanted 2. Age ≥18 years 3. LVEF ≥ 30% as estimated by echocardiography, contrast ventriculography, radionuclide imaging or cardiac magnetic resonance imaging within the previous 30 days. 4. Willing and capable of understanding the objective, risk, and requirement of the study, and providing consent. 5. Able and willing to comply with all pre-, post- and follow-up testing and requirements. Exclusion Criteria: 1. Definite protruding LV thrombus on pre-ablation imaging. 2. Myocardial infarction (MI) within the preceding 2 months. Patients with incessant VT (present 50% of the time with intervention for a period \>12 hrs) may be enrolled if their MI is at least 3 weeks old. 3. Absence of vascular access to the heart chambers. 4. Other disease process likely to limit survival to less than 6 months. 5. Class IV heart failure. 6. Serum creatinine of ≥ 2.5 mg/dl (221 umol/L). 7. Thrombocytopenia (\< 50 x 109/L) or coagulopathy. 8. Contraindication to heparin. 9. Women who are pregnant. 10. Cardiac surgery (i.e. ventriculotomy, atriotomy) within the past 2 months. Patients with incessant VT may be enrolled if their surgery is at least 3 weeks old. 11. Acute illness or active systemic infection. 12. Severe aortic stenosis or flail mitral valve. 13. Uncontrolled heart failure. 14. Significant congenital anomaly or medical problem that in the opinion of the principal Investigator would preclude enrollment in the study. 15. Enrolled in an investigational study evaluating another device or drug. 16. Unwilling to participate in the study or unavailable for follow up visits. 17. Previous VT ablation within a year. 18. Epicardial mapping or ablation is anticipated or planned before the VT ablation procedure.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • IUCPQ

    Québec, Quebec, Canada

  • McGill University Health Centre

    Montreal, Quebec, Canada

  • Montreal Heart Institute

    Montreal, Quebec, Canada

More trials for these conditions

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