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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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Ages Eligible for Study: Â
18 Years and older  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Accepts Healthy Volunteers: Â
No
Sampling Method: Â
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      Â
Onassis Cardiac Surgery Center
Athens, Greece
Contact: Konstantinos G Vlachos      Â
Virgen de las Nieves University Hospital
Granada, Spain
Contact: Pablo J Sánchez-Millán      Â
Arrhythmia Unit, University Hospital RamĂłn y Cajal
Madrid, Spain
Contact: Javier Moreno      Â
Basildon University Hospital
Basildon, United Kingdom
Contact: Neil Srinivasan, MBBS   +(44)1268 524900 ext 44100   neil.srinivasan2@nhs.net  Â
Royal Sussex County Hospital
Brighton, United Kingdom
Contact: John Silberbauer      Â
Royal Brompton & Harefield hospital
London, United Kingdom
Contact: Chen Zhong      Â
St Bartholomew’s Hospital
London, United Kingdom
Contact: Ross Hunter      Â
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 Â Â
Other Study ID Numbers:
315453
First Posted:
February 1, 2023 Â Â 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.
