Outcomes of Functional Substrate Mapping of Ventricular Tachycardia

NCT ID: NCT05708131

Last Updated: 2024-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-13

Study Completion Date

2024-12-01

Brief Summary

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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

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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

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Ventricular Tachycardia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Mid and South Essex NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil Srinvasan, MBBS

Role: PRINCIPAL_INVESTIGATOR

Mid and South Essex NHS FT

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Onassis Cardiac Surgery Center

Athens, , Greece

Site Status RECRUITING

Virgen de las Nieves University Hospital

Granada, , Spain

Site Status RECRUITING

Arrhythmia Unit, University Hospital Ramón y Cajal

Madrid, , Spain

Site Status RECRUITING

Basildon University Hospital

Basildon, , United Kingdom

Site Status RECRUITING

Royal Sussex County Hospital

Brighton, , United Kingdom

Site Status RECRUITING

Royal Brompton & Harefield hospital

London, , United Kingdom

Site Status RECRUITING

St Bartholomew's Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United States Greece Spain United Kingdom

Central Contacts

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Neil Srinivasan, MBBS

Role: CONTACT

+(44)1268 524900 ext. 44100

Fatima Bangash, MBBS

Role: CONTACT

Facility Contacts

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Pasquale Santangeli

Role: primary

Konstantinos G Vlachos

Role: primary

Pablo J Sánchez-Millán

Role: primary

Javier Moreno

Role: primary

Neil Srinivasan, MBBS

Role: primary

+(44)1268 524900 ext. 44100

John Silberbauer

Role: primary

Chen Zhong

Role: primary

Ross Hunter

Role: primary

Other Identifiers

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315453

Identifier Type: -

Identifier Source: org_study_id

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