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New Diamond-Tipped catheter takes on heart rhythm disorder
NCT ID NCT06028919
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial tested a new ablation catheter (DiamondTemp) against the current standard (Tacticath/Tactiflex) for treating ventricular tachycardia (VT), a life-threatening fast heart rhythm. 61 adults with VT who needed ablation took part. The goal was to see if the new catheter is as safe and effective at reducing VT episodes over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DiamondTemp ablation catheter (device) vs Tacticath/Tactiflex ablation catheter (device)
- What this could lead to
- If the DiamondTemp catheter works as well as the standard one, it could offer doctors another safe and effective tool to treat VT and reduce the need for painful shocks from defibrillators.
- What could go wrong
- This is a small, completed trial with only 61 people, so results may not apply to everyone. The new catheter might not be as effective or safe as the current standard, and any ablation procedure carries risks like bleeding or heart damage.
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
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61 people
The number who actually took part.
- Started
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Sep 2022
- Finished
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Nov 2025
- Lead sponsor
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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
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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: * ≥ 18 years of age to give informed consent specific to national legal requirements. * Subject with 1 of the following: 1. Symptomatic VT (despite optimal medical therapy), 3 or more episodes of VT within 24 h (VT storm). 2. At least 3 episodes of VT requiring anti-tachycardia pacing (ATP) 3. At least one appropriate ICD shock. * Referred for VT ablation by Consultant Electrophysiologist * Subject discussed at cardiac EP MDT * Suitable candidate for intra-cardiac mapping and ablation of arrhythmia. * Subject agrees to comply with study procedures and be available for routine follow up visits for at least 12 months after enrolment. * Subject is willing and able to provide written consent Exclusion Criteria: * BMI \>40kg/m2 * Presence of intramural thrombus, tumour or abnormality that precludes vascular access, catheter introduction or manipulations. * Coagulopathy, bleeding diathesis or suspected pro-coagulant state. * Sepsis, active systemic infection or fever (\>100.5 F/38 C) within a week prior to the ablation procedure. * Significant restrictive or obstructive pulmonary disease or chronic respiratory condition. * Renal failure requiring dialysis or renal compromise that in the investigators judgement would increase risk to the subject or deem the subject inappropriate to participate in the study. * Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that can't be adequately pre-treated prior to the ablation procedure. * Positive pregnancy test results for female subjects of childbearing or potential or breast feeding. * Enrolment in a concurrent clinical study that in the judgement of the investigator would increase risk to the subject or deem the subject inappropriate to participate in the study. * Significant GI bleed.
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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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University Hospital Coventry and Warwickshire NHS Trust
Coventry, West Midlands, CV22DX, United Kingdom
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University Hospitals Sussex NHS Foundation Trust
Brighton, BN2 1ES, United Kingdom
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Other studies related to the condition(s) this trial covers.
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