Validation of Beat-to-beat Wavefront Direction Using Omnipolar Mapping
ATOM
1 other identifier
observational
20
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 18, 2020
CompletedFirst Submitted
Initial submission to the registry
May 20, 2021
CompletedFirst Posted
Study publicly available on registry
May 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedFebruary 10, 2022
January 1, 2022
2.1 years
May 20, 2021
January 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Omnipolar real time wavefront direction is non inferior to LAT map.
Maps will be compared post EP Study.
1 year
Study Arms (1)
Group 1
Interventions
Analyse intracardiac EGMs collected with the HD Grid catheter (Abbott, Chicago, IL) during routine Atrial Flutter ablation using the Omnipolar algorithm.
Eligibility Criteria
Patients with persistent Atrial Flutter that have been listed on a clinical basis to have a Cavotricuspid Isthmus ablation (Atrial Flutter Ablation).
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Healthcare NHS Trustlead
- Abbottcollaborator
Study Sites (1)
Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2021
First Posted
May 25, 2021
Study Start
June 18, 2020
Primary Completion
August 1, 2022
Study Completion
August 1, 2022
Last Updated
February 10, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share
No IPD will be shared.