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Substrate Remodelling and Targeted Ablation in AF

Study acronym: STRATA-AF
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Nov 18, 2025 to Nov 18, 2029
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2025 to Nov 7, 2025
    v3
  2. Notable Primary completion date: Aug 2029 to Nov 18, 2025
    • Study completion date: Aug 2029 to Aug 18, 2030
    • Start date: Aug 2025 to Sep 2025
    • Interventions: Pulmonary vein reisolation and ganglionic plexi ablation (Procedure), Pulmonary vein reisolation, ganglionic plexi ablation and conduction… to Ganglionic plexi ablation (Procedure), Pulmonary vein reisolation (Procedure), Substrate ablation (Procedure)
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Atrial fibrillation (AF) is the most common heart rhythm disorder, affecting millions worldwide and causing symptoms such as palpitations, fatigue and breathlessness. It also increases the risk of stroke and heart failure, so effective treatment is essential. A treatment for AF involves catheter ablation, a minimally invasive procedure where problematic areas of the heart are targeted using controlled energy. This is done by passing wires called catheters, through blood vessels at the top of the leg all the way to the heart. However, this isn't effective for everyone and approximately half of patients experience a return of AF despite treatment. In this researcher-led study at St Bartholomew's Hospital , the investigators will use a method called electroanatomical mapping to make a 3D picture of the left atrium, the heart's upper left chamber. To make this picture more detailed, information will be collected - such as how strong electrical signals are (voltage), how fast and in which direction they travel through the heart to describe abnormal areas and areas of scar within the heart. Information will also be gathered about the routes electricity takes and the nerve activity in the heart muscle. These detailed maps will help to understand why AF can continue indefinitely in some people, why ablation works for some people and not others, and improve how ablations are done to make them more effective. All participants will undergo catheter ablation with these mapping methods integrated into the procedure. If AF recurs, patients will be invited for a second ablation targeting specific abnormal areas depending on the amount of scar found. This will be standardised across patients. Patients will be followed for 12 months, with structured visits at 3, 6, 9 and 12 months and 48-hour ECG recorders at 6 and 12 months. By tracking how the heart's structure and electrical behaviour evolve, the aim is to to see if map-guided ablation reduces the need for further procedures, lowers healthcare costs and improves quality of life. Ultimately, this study will provide clear, reproducible insights into AF mechanisms and yield practical guidance so clinicians can predict who will benefit from standard ablation treatment and who may require extra, map-guided treatment.
Trial Details
NCT Number NCT07047235
Lead Sponsor Barts & The London NHS Trust
Conditions
(from sponsor)
Atrial Fibrillation (AF), Atrial Fibrillation Mechanisms, Catheter Ablation, Low Voltage Areas
Related terms Atrial Fibrillation
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov