Status:
COMPLETED
Validation of the Advisor HD Grid Mapping Catheter in Atrial Fibrillation Ablation
Lead Sponsor:
University of Calgary
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Brief Summary
The primary study concept is to evaluate the superiority of the HD Grid high-density mapping catheter over the current standard 20-pole circular mapping catheter in pulmonary vein isolation (PVI) in a...
Detailed Description
Background and Rationale: The main target in atrial fibrillation ablation is the isolation of the pulmonary veins (PVI). This is performed by point-by-point ablation with radiofrequency energy creati...
Eligibility Criteria
Inclusion
- Patients with symptomatic paroxysmal or persistent atrial Fibrillation.1
- Patients referred for a clinically indicated catheter ablation with a plan for PVI only.
- 18-85 year of age at time of consent.
- Able and willing to comply with all protocol requirements.
- Signed patient Informed Consent (ICF).
Exclusion
- History of prior left-sided catheter or surgical ablation for AF or atypical atrial flutter, including MAZE or mini MAZE. Prior ablation for typical atrial flutter or left-sided ablation for WPW, AV-node reentry tachycardia or right-sided focal ectopic atrial tachycardia may be included.
- Planned for left atrial ablation beyond PVI.
- Uncontrolled heart Failure or NYHA Class III or IV heart failure.
- Left ventricular ejection fraction \< 35 %
- Left atrial size \> 55 mm diameter on echocardiogram.
- Severe Pulmonary Hypertension
- Reversible causes of AF (electrolyte imbalance, thyroid disease…)
- Poor candidate for general anesthesia or deep sedation
- Anticipated survival \< 1 year
- MI or CABG within 3 months, severe valvular disease
- Any documented thromboembolic event within 6 months.
- Contraindication to systemic oral anticoagulation therapy.
- Significant congenital anomaly or medical condition that may affect the integrity of study data.
- Women who are pregnant or breastfeeding.
- Active enrollment in another investigational study involving a drug or device.
Key Trial Info
Start Date :
September 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04850508
Start Date
September 27 2021
End Date
November 1 2022
Last Update
November 15 2022
Active Locations (1)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6