Outcomes of Functional Substrate Mapping of Ventricular Tachycardia

Outcomes of Functional Substrate Mapping of Ventricular Tachycardia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT05708131

Recruitment Status : **RECRUITING NOW**
First Posted : February 1, 2023
Last Update Posted : February 1, 2023

Sponsor:

Collaborator:

Information provided by (Responsible Party):
Mid and South Essex NHS Foundation Trust

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Brief 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. Mortality and the need for ICD therapies at 12 months post-ablation will be compared with propensity-matched controls undergoing substrate-based ablation alone.

Ventricular Tachycardia

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.

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Study Type :
Observational [Patient Registry]

Estimated Enrollment :
70 participants

Observational Model:
Case-Control

Time Perspective:
Prospective

Target Follow-Up Duration:
12 Months

Official Title:
Outcomes of Functional Substrate Mapping of Ventricular Tachycardia (Func-VT) – an International Propensity-matched Prospective Registry

Actual Study Start Date :
July 13, 2022

Estimated Primary Completion Date :
December 1, 2023

Estimated Study Completion Date :
December 1, 2024

Resource links provided by the National Library of Medicine

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Primary Outcome Measures :

Composite of cardiovascular mortality and ICD therapy [ Time Frame: 12 months ]
Composite of cardiovascular mortality and ICD therapy

Secondary Outcome Measures :

Length of hospital stay [ Time Frame: 1 month ]
Length of hospital stay

LV function on echocardiogram [ Time Frame: 6 months ]
LV function on echocardiogram

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Information from the National Library of Medicine
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Ages Eligible for Study:  
18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  
All

Accepts Healthy Volunteers:  
No

Sampling Method:  
Non-Probability Sample

Hospital

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

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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05708131

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Contact: Pasquale Santangeli         

Onassis Cardiac Surgery Center

Athens, Greece

Contact: Konstantinos G Vlachos         

Virgen de las Nieves University Hospital

Granada, Spain

Contact: Pablo J Sánchez-Millán         

Arrhythmia Unit, University Hospital Ramón y Cajal

Madrid, Spain

Contact: Javier Moreno         

Basildon University Hospital

Basildon, United Kingdom

Contact: Neil Srinivasan, MBBS    +(44)1268 524900 ext 44100    neil.srinivasan2@nhs.net   

Royal Sussex County Hospital

Brighton, United Kingdom

Contact: John Silberbauer         

Royal Brompton & Harefield hospital

London, United Kingdom

Contact: Chen Zhong         

St Bartholomew’s Hospital

London, United Kingdom

Contact: Ross Hunter         

Mid and South Essex NHS Foundation Trust
Abbott

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

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Responsible Party:
Mid and South Essex NHS Foundation Trust

ClinicalTrials.gov Identifier:
NCT05708131    

Other Study ID Numbers:
315453

First Posted:
February 1, 2023    Key Record Dates

Last Update Posted:
February 1, 2023

Last Verified:
January 2023

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Studies a U.S. FDA-regulated Drug Product:
No

Studies a U.S. FDA-regulated Device Product:
No

Additional relevant MeSH terms:

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TachycardiaTachycardia, VentricularArrhythmias, CardiacHeart Diseases
Cardiovascular DiseasesCardiac Conduction System DiseasePathologic Processes

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

February 2, 2023Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
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