Freezing heart tissue may stop deadly rhythms
NCT ID NCT04893317
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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64 people
The number who actually took part.
- Started
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May 2021
- Finished
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Sep 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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CHU-Bordeaux, Pôle cardio-thoracique, Hôpital Haut-Lévêque
Bordeaux, France
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Herzzentrum Leipzig Universitätsklinik für Kardiologie
Leipzig, Germany
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McGill University Health Centre
Montreal, Canada
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Montreal Hear Institute
Montreal, Canada
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Nemocnice na Homolce
Prague, Czechia
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Onze Lieve Vrouwziekenhuis
Aalst, Aalst, 9300, Belgium
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St Antonius Ziekenhuis
Nieuwegein, Netherlands
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