UnknownNot Applicable

Validation of Beat-to-beat Wavefront Direction Using Omnipolar Mapping

United Kingdom20 participantsStarted 2020-06-18

Plain-language summary

To validate omnipolar mapping in a well-described circuit within the heart (Atrial Flutter) and compare it with the gold standard of Local Activation Time (LAT) mapping during routine, clinically indicated procedures of Atrial Flutter ablation. A conventional, LAT map will be created during the procedure, prior to treatment, to guide the procedure. A repeat map will be performed after ablation during the procedure. The investigators will export the map files for off-line analysis with the omnipolar software.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Suitable candidate for catheter mapping/ablation of arrhythmias.
✓. Eighteen (18) to eighty-five (85) years of age.
✓. Body Mass Index (BMI) \<40 (Wt. in Kgs / Ht. in cm).
✓. Signed Informed Consent.

Exclusion criteria

✕. Severe cerebrovascular disease
✕. Moderate to severe renal impairment (eGFR\<30 ml/min/1.73m2)
✕. Active gastrointestinal bleeding.
✕. Active infection or fever.
✕. Short life expectancy.
✕. Significant anaemia.
✕. Severe uncontrolled systemic hypertension.
✕. Severe electrolyte imbalance.

What they're measuring

Omnipolar real time wavefront direction is non inferior to LAT map.

Timeframe: 1 year

Trial details

NCT IDNCT04900831

SponsorImperial College Healthcare NHS Trust

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-08-01

Contact for this trial

Dimitrios Panagopoulos

+447858778189 d.panagopoulos@nhs.net

View on ClinicalTrials.gov More Atrial Flutter Typical trials