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Freezing heart tissue may stop deadly rhythms

NCT ID NCT04893317

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new freezing method (cryoablation) to treat a fast, dangerous heart rhythm called ventricular tachycardia. 64 adults who had not responded well to medication took part. The goal was to see if freezing the small area causing the problem could safely stop the rhythm for at least 6 months.

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

64 people

The number who actually took part.

Started

May 2021

Finished

Sep 2024

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: IC 1 Male or female the ages of ≥ 18 years IC 2 Eligible for a catheter ablation due to Ischemic and/or non-ischemic recurrent symptomatic sustained monomorphic Ventricular Tachycardia also defined as having a similar QRS configuration from beat to beat. IC 3 Has or will be receiving an ICD prior to hospital discharge post procedure. IC 4 Refractory to at least one AAD (Refractory is defined as an AAD not able to treat the arrhythmia satisfactorily or induces unwanted side effects). IC 5 Subject has LVEF \> 20%, confirmed by echo or comparable technique in the previous 3 months or during baseline evaluation IC 6 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study IC 7 Willingness and ability to give an informed consent Exclusion Criteria: EC 1 Any known objective contraindication to ventricular tachycardia ablation, TEE, or anticoagulation, including but not limited to the identification of any cardiac thrombus or evidence of sepsis EC 2 Any duration of continuous arrythmia that is not monomorphic ventricular tachycardia. Multiple monomorphic tachycardia is acceptable, but polymorphic VT is not. EC 3 Any VT ablation within 4 weeks prior to enrollment EC 4 More than one prior (\>4 weeks) Ventricular Tachycardia ablation or prior surgical treatment for ventricular tachycardia EC 5 Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause EC 6 Structural heart disease as described below: 1. Class IV heart failure 2. Aortic aneurysm 3. Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to the procedure 4. Interatrial baffle, closure device, patch, or PFO occlusion device 5. IVC filter 6. Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure 7. Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE 8. Cardiac myxoma 9. Significant congenital anomaly 10. Recent Myocardial Infarct (MI) or unstable angina, within 60 days prior to the ablation procedure 11. Mechanical aortic or mitral valve EC 7 Any previous history of cryoglobulinemia EC 8 History of blood clotting or bleeding disease EC 9 Any prior history of documented cerebral vascular accident (CVA), TIA or systemic embolism (excluding a post-operative Deep Vein Thrombosis, DVT), within 6 months prior to the ablation procedure. EC 10 Breastfeeding, pregnant, or anticipated pregnancy during study follow-up EC 11 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study EC 12 Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, candidate for heart transplantation, patient with ventricular assist device, or terminal illness with a life expectancy less than 12 months)

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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

  • CHU-Bordeaux, Pôle cardio-thoracique, Hôpital Haut-Lévêque

    Bordeaux, France

  • Herzzentrum Leipzig Universitätsklinik für Kardiologie

    Leipzig, Germany

  • McGill University Health Centre

    Montreal, Canada

  • Montreal Hear Institute

    Montreal, Canada

  • Nemocnice na Homolce

    Prague, Czechia

  • Onze Lieve Vrouwziekenhuis

    Aalst, Aalst, 9300, Belgium

  • St Antonius Ziekenhuis

    Nieuwegein, Netherlands

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