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Search / Trial NCT02628730

Pulmonary Vein Reconnection Following Ablation Index-guided Ablation: a Success Evaluation

Launched by LIVERPOOL HEART AND CHEST HOSPITAL NHS FOUNDATION TRUST · Dec 9, 2015

Trial Information

Current as of June 12, 2025

Unknown status

Keywords

Atrial Fibrillation Ablation Pulmonary Vein Isolation Ablation Index

ClinConnect Summary

The study is a prospective cohort study in 40 patients with Persistent AF. It will comprise two groups:

1. Active Group (AI guided ablation): An initial pulmonary vein isolation (PVI) procedure will be performed guided by AI targets. All patients (regardless of AF recurrence) will undergo a repeat EP study at 8-10 weeks to identify and re-ablate site(s) of PV reconnection
2. Historical control group (Contact Force Guided Ablation): will be formed by the 40 patients enrolled to the repeat study arm of the PRESSURE study (ClinicalTrials.gov Identifier: NCT01942408). All 40 patients underwent...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Aged over 18 years
  • Persistent AF (defined, according to the ESC/EHRA Guidelines for the Management of Atrial Fibrillation 2010, as AF episode that either lasts longer than 7 days or requires termination by cardioversion, either with drugs or by direct current cardioversion (DCC) ).
  • Symptomatic in spite of drug treatment
  • Due to undergo pulmonary vein isolation by RF ablation
  • Exclusion Criteria:
  • Inability or unwillingness to receive oral anticoagulation with a Vitamin K antagonist (VKA) or non-VKA (NOAC) agent
  • Previous catheter or surgical ablation procedure for AF
  • Unwillingness or inability to complete the required follow-up arrangements
  • Current pattern of paroxysmal AF
  • Long standing persistent AF (continuous AF longer than 12 months before ablation)
  • Prior prosthetic mitral valve replacement or severe structural cardiac abnormality
  • Known infiltrative cardiomyopathy
  • Known severe left ventricular systolic function (ejection fraction \<35%)
  • Pregnancy

About Liverpool Heart And Chest Hospital Nhs Foundation Trust

Liverpool Heart and Chest Hospital NHS Foundation Trust is a leading healthcare institution in the UK, specializing in cardiothoracic care and research. Renowned for its commitment to clinical excellence and innovative practices, the Trust plays a pivotal role in advancing medical knowledge through rigorous clinical trials. With a multidisciplinary team of experts, it focuses on developing and evaluating new treatments and interventions for heart and lung conditions, ensuring high standards of patient safety and care. The Trust's dedication to enhancing patient outcomes and contributing to the field of cardiology and thoracic medicine positions it as a key player in the NHS's research landscape.

Locations

Newcastle Upon Tyne, , United Kingdom

Milan, , Italy

Liverpool, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Dhiraj Gupta, MD, DM, FRCP

Study Chair

Liverpool Heart and Chest Hospital, Liverpool, UK

Ahmed A Hussein, MRCP, MSc

Principal Investigator

Liverpool Heart and Chest Hospital, Liverpool, UK

Moloy Das

Principal Investigator

Freeman Hospital, Newcastle, UK

Antonio D Russo

Principal Investigator

Centro Cardiologico Monzino

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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