Outcomes of Functional Substrate Mapping of Ventricular Tachycardia (VTFM)

January 11, 2024 updated by: Mid and South Essex NHS Foundation Trust

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Athens, Greece
        • Recruiting
        • Onassis Cardiac Surgery Center
        • Contact:
          • Konstantinos G Vlachos
  • Spain
      • Granada, Spain
        • Recruiting
        • Virgen de las Nieves University Hospital
        • Contact:
          • Pablo J Sánchez-Millán
      • Madrid, Spain
        • Recruiting
        • Arrhythmia Unit, University Hospital Ramón y Cajal
        • Contact:
          • Javier Moreno
  • United Kingdom
      • Basildon, United Kingdom
        • Recruiting
        • Basildon University Hospital
        • Contact:
      • Brighton, United Kingdom
        • Recruiting
        • Royal Sussex County Hospital
        • Contact:
          • John Silberbauer
      • London, United Kingdom
        • Recruiting
        • St Bartholomew's Hospital
        • Contact:
          • Ross Hunter
      • London, United Kingdom
        • Recruiting
        • Royal Brompton & Harefield hospital
        • Contact:
          • Chen Zhong
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Contact:
          • Pasquale Santangeli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hospital

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of cardiovascular mortality and ICD therapy
Time Frame: 12 months
Composite of cardiovascular mortality and implantable cardioverter-defibrillator (ICD) therapy
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: 1 month
Length of hospital stay
1 month
Left ventricular function on echocardiogram
Time Frame: 6 months
Left ventricular function on echocardiogram
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mid and South Essex NHS Foundation Trust

Collaborators

Abbott

Investigators

  • Principal Investigator: Neil Srinvasan, MBBS, Mid and South Essex NHS FT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 315453

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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