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FEATHERNCT07116525

A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved at least 4 months later, primary endpoint(s) modified.

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Record History

All 12 versions: 8 with changes below, 4 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 30, 2026 to Feb 7, 2027
  2. Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 2 of 5 entries
  3. Study sites: 6 to 5v10
  4. Primary endpoint(s) modified
    • Secondary endpoints revised (5)
    v9
  5. Enrollment increased: 60 → 90 participants
    • Study completion pushed from Sep 30, 2026 to Feb 7, 2027
    • Site details revised at 1 of 6 sites
    v7
Show 2 earlier versionsHide 2 earlier versions
  1. Site details revised at 3 of 6 sitesv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 6 of 6 sites
    v3
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Occurrence of Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter When Used for Endocardial Mapping
Timeframe: Up to 7 days post index procedure
Occurrence of Completion of All Pre-Ablation Endocardial Mapping Requirements and Any Clinically Indicated Endocardial Mapping
Timeframe: Up to 7 days post index procedure

Secondary (5)

Investigator Assessment of Deployment; Visualization; Maneuverability and Signal Quality
Occurrence of SAEs Related to the Investigational Catheter When Used for Epicardial Mapping as per Physician's Discretion
Occurrence of all Other SAEs Not Related to the Investigational Catheter
Occurrence of Non-serious Adverse Events (AEs) Related to the Investigational Catheter
Occurrence of Completion of all Pre-ablation Epicardial Mapping Requirements and Any Clinically Indicated Epicardial Mapping With the Investigational Catheter as Per Physician's Discretion

Arms and interventions

Arrhythmia Mapping by a Paddle-shaped, High-density, Multi-electrode Mapping CatheterExperimental

Participants scheduled to have a clinically indicated mapping and ablation procedure for the management of cardiac arrhythmias. The investigational paddle-shaped, high-density, multi-electrode catheter is used for mapping purposes only.

Devices: Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter

Sites

5 sites in 3 countries

Belgium 2, France 2, Lithuania 1