Ventricular TachycardiaVTFMNCT05708131
Outcomes of Functional Substrate Mapping of Ventricular Tachycardia
An observational study of Ventricular Tachycardia, run by Mid and South Essex NHS Foundation Trust at 8 sites in 4 countries.
Trial summary
The goal of this registry database is to demonstrate the safety and effectiveness of functional ventricular tachycardia (VT) ablation using SENSE protocol in patients with ischaemic VT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- How many people
- 70 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 13 Jul 2022to 1 Dec 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital
Who may be able to join
- One of the following VT events (within the last 6 months) + Ejection Fraction <40%:
- A: ≥3 episodes of VT treated with anti-tachycardia pacing (ATP), at least one of which is symptomatic.
- B: ≥1 appropriate ICD shock. C: ≥3 VT episodes within 24 hr. D: Sustained VT below the detection rate of the ICD.
Who cannot join
- Contraindication to VT ablation
- Renal failure (CrCl < 15 mL/min)
- NYHA IV or CCS IV angina
- STEMI within 1 month
- CABG within 3 months
- PCI within 1 month
- Pregnant
- Life expectancy < 1 year
Trial locations and contacts
8 sites in 4 countries.
Fatima Bangash, MBBS contact
8 sites in 4 countries
United Kingdom4 sites, 4 recruiting
- Recruiting
Basildon University Hospital
Basildon
Neil Srinivasan, MBBS, +(44)1268 524900 ext. 44100, neil.srinivasan2@nhs.net
- Recruiting
Royal Sussex County Hospital
Brighton
John Silberbauer
- Recruiting
Royal Brompton & Harefield hospital
London
Chen Zhong
- Recruiting
St Bartholomew's Hospital
London
Ross Hunter
Spain2 sites, 2 recruiting
- Recruiting
Virgen de las Nieves University Hospital
Granada
Pablo J Sánchez-Millán
- Recruiting
Arrhythmia Unit, University Hospital Ramón y Cajal
Madrid
Javier Moreno
United States1 site, 1 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pasquale Santangeli
Greece1 site, 1 recruiting
- Recruiting
Onassis Cardiac Surgery Center
Athens
Konstantinos G Vlachos
About this study
Official title: Outcomes of Functional Substrate Mapping of Ventricular Tachycardia (Func-VT) - an International Propensity-matched Prospective Registry
The goal of this registry database is to demonstrate the safety and effectiveness of functional ventricular tachycardia (VT) ablation using SENSE protocol in patients with ischaemic VT. Mortality and the need for ICD therapies at 12 months post-ablation will be compared with propensity-matched controls undergoing substrate-based ablation alone.
Read the detailed description
This is an international multicentre prospective registry. Participating centres will collect data during the pre-assessment, procedure, and follow-up visits at 6 and 12 months, according to standard practice. It is anticipated that the enrolment duration will be approximately 12 months, with the data being matched with that collected from a control group of patients undergoing conventional Ventricular tachycardia ablation methods.
- Conditions
- Ventricular Tachycardia
- Medical subject headings
- Tachycardia, Ventricular
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of cardiovascular mortality and ICD therapy
Composite of cardiovascular mortality and implantable cardioverter-defibrillator (ICD) therapy
Measured: 12 months
Secondary outcomes (2)
Length of hospital stay
Length of hospital stay
Measured: 1 month
Left ventricular function on echocardiogram
Left ventricular function on echocardiogram
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start13 Jul 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Neil Srinvasan, MBBS, Principal investigator, Mid and South Essex NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708131
- Sponsor's protocol ID
- 315453
- Acronym
- VTFM
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Functional Substrate Mapping of Ventricular Tachycardia (Func-VT) - an International Propensity-matched Prospective Registry
- ClinicalTrials.gov ID
- NCT05708131
- Acronym / sponsor ID
- VTFM / 315453
- Conditions
- Ventricular Tachycardia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this registry database is to demonstrate the safety and effectiveness of functional ventricular tachycardia (VT) ablation using SENSE protocol in patients with ischaemic VT. Mortality and the need for ICD therapies at 12 months post-ablation will be compared with propensity-matched controls undergoing substrate-based ablation alone.
Detailed description
This is an international multicentre prospective registry. Participating centres will collect data during the pre-assessment, procedure, and follow-up visits at 6 and 12 months, according to standard practice. It is anticipated that the enrolment duration will be approximately 12 months, with the data being matched with that collected from a control group of patients undergoing conventional Ventricular tachycardia ablation methods.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital
Key inclusion criteria (3 listed)
- A: ≥3 episodes of VT treated with anti-tachycardia pacing (ATP), at least one of which is symptomatic.
- B: ≥1 appropriate ICD shock. C: ≥3 VT episodes within 24 hr. D: Sustained VT below the detection rate of the ICD.
Key exclusion criteria (8 listed)
- Contraindication to VT ablation
- Renal failure (CrCl < 15 mL/min)
- NYHA IV or CCS IV angina
- STEMI within 1 month
- CABG within 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite of cardiovascular mortality and ICD therapy
Time frame: 12 months
Composite of cardiovascular mortality and implantable cardioverter-defibrillator (ICD) therapy
2 secondary outcomes
Length of hospital stay
Time frame: 1 month
Left ventricular function on echocardiogram
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
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Assessment of Combined CCM and ICD Device in HFrEF
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatima Bangash, MBBS contact
Neil Srinvasan, MBBS principal investigator
Mid and South Essex NHS FT
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia, run by Mid and South Essex NHS Foundation Trust at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Spain, United States, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neil Srinivasan, MBBS (+(44)1268 524900 ext. 44100, neil.srinivasan2@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of cardiovascular mortality and ICD therapy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.