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A Randomised Control Trial of Power Versus Temperature-controlled Irrigated Radiofrequency Ablation for the Treatment of Ventricular Tachycardia (DTinVT)

Primary Purpose

Ventricular Tachycardia

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Temperature controlled DiamondTemp (DT) ablation catheter
Tacticath/Tactiflex (TF) ablation catheter
Sponsored by
University Hospitals Coventry and Warwickshire NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia focused on measuring temperature controlled irrigated radiofrequency ablation, ventricular tachycardia, clinical outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥ 18 years of age to give informed consent specific to national legal requirements. Subject with 1 of the following: Symptomatic VT (despite optimal medical therapy), 3 or more episodes of VT within 24 h (VT storm). At least 3 episodes of VT requiring anti-tachycardia pacing (ATP) 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.

Sites / Locations

  • University Hospital Coventry and Warwickshire NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Temperature controlled DiamondTemp (DT) ablation catheter

Power controlled Tacticath/Tactiflex ablation catheter

Arm Description

Intervention arm

Control arm

Outcomes

Primary Outcome Measures

Assessing the efficacy of the DT versus the TF ablation catheter for the treatment of VT
The efficacy of each ablation catheter will be compared by measuring the VT burden 12 months post-ablation.
Assessing the safety of the DT versus the TF ablation catheter for the treatment of VT
The efficacy of each ablation catheter will be compared by measuring the freedom from a composite of pre-specified procedure-related complications (adverse outcomes).

Secondary Outcome Measures

Perceived health benefit of treatment
The patient's health benefit will be measured using a EQ-5D-5L questionnaire.

Full Information

First Posted
August 31, 2023
Last Updated
August 31, 2023
Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
Collaborators
Medtronic, Coventry University
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1. Study Identification

Unique Protocol Identification Number
NCT06028919
Brief Title
A Randomised Control Trial of Power Versus Temperature-controlled Irrigated Radiofrequency Ablation for the Treatment of Ventricular Tachycardia
Acronym
DTinVT
Official Title
A Randomised Control Trial of Power Versus Temperature-controlled Irrigated Radiofrequency Ablation for the Treatment of Ventricular Tachycardia (VT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
Collaborators
Medtronic, Coventry University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Ventricular Tachycardia (VT) is a life threatening heart rhythm that comes from the bottom chambers of the heart (the ventricles) and is a leading cause of sudden cardiac death. The majority of patients that are at risk of VT or suffer a cardiac arrest will have an Internal Cardiac Defibrillator (ICD) in situ to treat the abnormal heart rhythm. The ICD can deliver a painful shock to restore normal heart rhythm but importantly does not treat the underlying cause. Current treatment for the prevention of recurrent VT include catheter ablation (CA) or medication. Long-term results with global 12 month VT-free survival rates with CA are around 50%. The trial is to compare 2 different types of ablation catheter that are used to cauterise small areas of unhealthy tissue within the heart that are responsible for VT: Diamond Temp (DT) and Tacticath/Tactiflex (TF). Our hypothesis is that the DT ablation catheter will provide comparable efficacy and safety for the treatment of VT as the current industry gold standard (TF).
Detailed Description
This trial compares 2 different types of ablation catheter for the treatment of ventricular tachycardia (VT). VT is a life threatening heart rhythm that comes from the bottom chambers of the heart (the ventricles) and is associated with poor patient prognosis, outcomes and is a leading cause of sudden cardiac death in developed countries. Current treatments for VT include catheter ablation (CA), medication and having an internal cardiac defibrillator (ICD) implanted, each treatment has advantages and disadvantages. The ICD can deliver a lifesaving shock but this doesn't treat the cause of the VT and can be very painful and upsetting for the patient. Medications can reduce the amount and rate of VT but can have dangerous side effects. CA involves small tubes being placed in the heart and small areas of unhealthy heart tissue are burnt (ablated) to stop the VT. This is the only treatment that treats the underlying cause but long-term success is about 50% after 1 year. We want to improve the success rates of VT ablation. There is a new ablation catheter called Diamond Temp which works differently to the current industry gold standard (Tacticath/Tactiflex Catheter). We think the Diamond Temp catheter will be better than the Tacticath catheter but need to do this trial to prove it. This trial will be at University Hospital Coventry and Warwickshire and University Hospitals Sussex involving patients that suffer VT, have an ICD and need an ablation. If a patient wishes to participate they will give consent and be chosen at random to receive ablation with either Diamond temp or Tacticath/Tactiflex. All other treatment will be the same as after a normal ablation procedure. Participants will be followed up at 6 months and 1 year after the procedure as well as being monitored by the ICD clinic. The study will have 54 patients and be completed in 2025.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
temperature controlled irrigated radiofrequency ablation, ventricular tachycardia, clinical outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patient-blinded, prospective, multi centre, two-arm, randomised controlled trial
Masking
Participant
Masking Description
The patient will be blinded to which trial arm they have been assigned.
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Temperature controlled DiamondTemp (DT) ablation catheter
Arm Type
Other
Arm Description
Intervention arm
Arm Title
Power controlled Tacticath/Tactiflex ablation catheter
Arm Type
Other
Arm Description
Control arm
Intervention Type
Device
Intervention Name(s)
Temperature controlled DiamondTemp (DT) ablation catheter
Intervention Description
The DiamondTemp catheter is a new ablation catheter that uses 6 industrial grade diamonds to actually measure the temperature of the surface tissue being cauterised. This enables the DiamondTemp catheter to control the amount of power being delivered from the ablation catheter into the tissue being ablated by maintaining a constant temperature at the surface of the heart.
Intervention Type
Device
Intervention Name(s)
Tacticath/Tactiflex (TF) ablation catheter
Intervention Description
The Tactiflex ablation catheter is currently the market leader and routinely used for VT ablation.
Primary Outcome Measure Information:
Title
Assessing the efficacy of the DT versus the TF ablation catheter for the treatment of VT
Description
The efficacy of each ablation catheter will be compared by measuring the VT burden 12 months post-ablation.
Time Frame
12 months post ablation
Title
Assessing the safety of the DT versus the TF ablation catheter for the treatment of VT
Description
The efficacy of each ablation catheter will be compared by measuring the freedom from a composite of pre-specified procedure-related complications (adverse outcomes).
Time Frame
within 30 days or 6 months after index ablation procedure
Secondary Outcome Measure Information:
Title
Perceived health benefit of treatment
Description
The patient's health benefit will be measured using a EQ-5D-5L questionnaire.
Time Frame
at baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 18 years of age to give informed consent specific to national legal requirements. Subject with 1 of the following: Symptomatic VT (despite optimal medical therapy), 3 or more episodes of VT within 24 h (VT storm). At least 3 episodes of VT requiring anti-tachycardia pacing (ATP) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tarv Dhanjal, PhD
Phone
02476 965668
Email
Tarv.dhanjal@uhcw.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Cristiana Huhulea, MSc
Phone
024 7696 7476
Email
Dtinvt@uhcw.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarv Dhanjal, PhD
Organizational Affiliation
University Hospitals Coventry and Warwickshire NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Coventry and Warwickshire NHS Trust
City
Coventry
State/Province
West Midlands
ZIP/Postal Code
CV22DX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristiana Huhulea, MSc
Phone
024 7696 7476
Ext
27476
Email
cristiana.huhulea@uhcw.nhs.uk
First Name & Middle Initial & Last Name & Degree
Violet Matthews, BA
Phone
024 7696 6197
Ext
26197
Email
Violet.Matthews@uhcw.nhs.uk
First Name & Middle Initial & Last Name & Degree
Tarv Dhanjal, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be made available to other researchers.

Learn more about this trial

A Randomised Control Trial of Power Versus Temperature-controlled Irrigated Radiofrequency Ablation for the Treatment of Ventricular Tachycardia

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