Status:
UNKNOWN
HCM-AF Ablation With ACUTUS
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Collaborating Sponsors:
Acutus Medical
Conditions:
Atrial Fibrillation
Hypertrophic Cardiomyopathy
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
BACKGROUND About 1/4 of patients with hypertrophic cardiomyopathy (HCM) seem to develop atrial fibrillation (AF) over their life-span. Typically, symptoms of heart failure and especially shortness of ...
Detailed Description
FOLLOW UP Patients will be followed up at 3, 6, and 12months with: * clinical visit, symptoms questionnaire, electrocardiogram (ECG), ECG Holter (3, 6, and 12 months); * trans-thoracic echocardiogra...
Eligibility Criteria
Inclusion
- Paroxysmal or persistent AF (time in persistent AF \< 12 months duration) including re-ablations
- Able to give written informed consent
- Age \>18 years old and ≤ 80 years
- Fulfil established clinical criteria for diagnosis of HCM and catheter ablation of atrial fibrillation
- Normal LV ejection fraction and no evidence of other significant structural heart disease
Exclusion
- Reversible causes of AF/flutter/tachycardia
- Recent cardiovascular event including TIA
- Intolerance or unwillingness to oral anticoagulation with Warfarin or NOAC
- Bleeding disorder
- Contraindication to CT or CMR scan
- Presence of intra-cardiac thrombus
- Vascular disorder preventing access to femoral veins
- Cardiac congenital abnormality different from HCM
- Severe, life threatening non cardiac disease
- Active malignant disease and recent (\<5 years) malignant disease
- Presence of ASD or PFO closure device
- Previous ASD or PFO surgical closure
- Unable or unwilling to comply with F/U requirements
- Pregnancy
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04090437
Start Date
October 1 2019
End Date
February 1 2021
Last Update
September 19 2019
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