Status:
UNKNOWN
Validation of Beat-to-beat Wavefront Direction Using Omnipolar Mapping
Lead Sponsor:
Imperial College Healthcare NHS Trust
Collaborating Sponsors:
Abbott
Conditions:
Atrial Flutter Typical
Eligibility:
All Genders
18-85 years
Brief 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 indi...
Detailed Description
Electroanatomical mapping of the chambers of the heart has revolutionised the way physicians treat heart rhythm disorders. However, there still are technical limitations that prevent us from gathering...
Eligibility Criteria
Inclusion
- Eligible patients on the waiting list for radiofrequency ablation of Atrial Flutter at the Hammersmith Hospital, Imperial College Healthcare NHS Trust.
- 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
- 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.
- Ejection fraction \<35%.
- Congestive heart failure (NYHA IV).
- Unstable angina requiring emergent PTCA (percutaneous transluminal coronary angioplasty) or CABG (Coronary Artery Bypass Grafting).
- Recent myocardial infarction.
- Bleeding or clotting disorders.
- Uncontrolled diabetes.
- Inability to receive IV or oral Anticoagulants.
- Unable to give informed consent (these patients would not be recruited).
- Previous catheter or surgical ablation treatment for Atrial Fibrillation.
- Previous catheter ablation treatment for Atrial Flutter.
- Pregnancy (urinary pregnancy test will be offered on the day of the procedure for all women of reproductive age)
- Drug and/or alcohol abuse.
- Patients who have participated in another study of an investigational medicinal product in the last 3 months.
Key Trial Info
Start Date :
June 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04900831
Start Date
June 18 2020
End Date
August 1 2022
Last Update
February 10 2022
Active Locations (1)
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1
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS