Recruiting

Observational Study

Sponsor:

Mid and South Essex NHS Foundation Trust

Code:

NCT05708131

Conditions

Ventricular Tachycardia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Ventricular Tachycardia

Study ID

NCT05708131

Start date

Jul 13, 2022

Status verified date

Jan, 2024

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Dec 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Neil Srinivasan, MBBS

+(44)1268 524900neil.srinivasan2@nhs.net

Fatima Bangash, MBBS

Fatima.bangash4@nhs.net

Locations

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

Mid and South Essex NHS Foundation Trust

Last update posted

Jan 12, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mid and South Essex NHS Foundation Trust on 2024-01-12.