Atrial Fibrillation Clinical Trial
Official title:
Dipole Intracardiac Mapping With ACUTUS System for Catheter Ablation of Atrial Fibrillation in Hypertrophic Cardiomyopathy
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 breath get much worse once AF is present. Catheter ablation of AF in
HCM has been proposed by several centres, but outcomes are much worse than in non-HCM AF.
Accurate mapping of the arrhythmia is crucial with regard to improving the procedural
outcome. Interestingly, intracardiac mapping during AF has demonstrated very long average
cycle length during ongoing AF in HCM which should make identification of the critical
re-entry/rotors much easier using dipole cardiac mapping (Acutus mapping system, Acutus
Medical, CA, USA).
POPULATION and PURPOSE This is a pilot trial recruiting a total of 20 patients with HCM and
AF (paroxysmal or persistent with <12 months duration time in persistent AF) eligible for
catheter ablation, without other significant structural heart disease Primary endpoints
Safety:
- Absence of acute adverse events due to the use of ACUTUS mapping system during AF
ablation
- Evidence of chronic adverse events due to the use of ACUTUS mapping system guided
catheter ablation during the 12 months F/U period
- Safety endpoint of the entire mapping and ablation strategy
Efficacy:
- Assessment on efficacy of ACUTUS mapping system guided AF ablation in HCM patients using
a double-arm study design
- RF time to termination of AF to SR Secondary endpoints
- RF time to termination of AF to atrial tachycardia (AT)
- Freedom from AF/flutter/tachycardia (> 30 sec) at the end of the 12 months follow up
(F/U) period
- Time to first recurrence of AF/flutter/tachycardia (> 30 sec)
- Freedom of AF/flutter/tachycardia on previously failed anti-arrhythmic medication
Ablation procedure First 10 patients (group 1): ablation will be carried out after
acquisition of a left atrium (LA) and right atrium (RA) dipole map at baseline, pre and
post administration of Adenosine IV. Then pulmonary vein isolation (PVI) as a first step
and subsequent remap and ablation of all patterns of interest in the LA until
restoration of sinus rhythm (SR) or decision to proceed with direct current
cardioversion (DCCV, 360J).
Second 10 patients (group 2): after the acquisition of a dipole map of LA and RA at baseline
(pre and post Adenosine IV administration), ablation of all identified areas of interest
(API) will be performed, followed by remap and finally PVI +/- DCCV.
For all patients: final step will be the deployment of a RA isthmus line and demonstration of
bidirectional block.
FOLLOW UP Patients will be followed up at 3, 6, and 12 months.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | February 1, 2021 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Paroxysmal or persistent AF (time in persistent AF < 12 months duration) including re-ablations 2. Able to give written informed consent 3. Age >18 years old and = 80 years 4. Fulfil established clinical criteria for diagnosis of HCM and catheter ablation of atrial fibrillation 5. Normal LV ejection fraction and no evidence of other significant structural heart disease Exclusion Criteria: 1. Reversible causes of AF/flutter/tachycardia 2. Recent cardiovascular event including TIA 3. Intolerance or unwillingness to oral anticoagulation with Warfarin or NOAC 4. Bleeding disorder 5. Contraindication to CT or CMR scan 6. Presence of intra-cardiac thrombus 7. Vascular disorder preventing access to femoral veins 8. Cardiac congenital abnormality different from HCM 9. Severe, life threatening non cardiac disease 10. Active malignant disease and recent (<5 years) malignant disease 11. Presence of ASD or PFO closure device 12. Previous ASD or PFO surgical closure 13. Unable or unwilling to comply with F/U requirements 14. Pregnancy |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Royal Brompton & Harefield NHS Foundation Trust | Acutus Medical |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical efficacy to achieve SR defined as time (in minutes) to termination of AF into stable SR | • Assessment on efficacy of ACUTUS mapping system guided AF ablation in HCM patients using a double-arm study design. Time to termination of AF to SR | 12 months | |
Primary | Acute procedural safety assessed by incidence (number and type) of acute procedure-related Adverse Events | • Absence of acute adverse events due to the use of ACUTUS mapping system during AF ablation | 12 months | |
Primary | Chronic procedural safety assessed by incidence (number and type) of chronic procedure-related Adverse Events | • Evidence of chronic adverse events due to the use of ACUTUS mapping system guided catheter ablation during the 12 months F/U period | 12 months | |
Primary | Overall safety of the entire mapping and ablation strategy defined by incidence (number and type) of acute and chronic Adverse Events, differentiated into those related to the mapping system (ACUTUS) and those related to the ablation procedure | • Safety endpoint of the entire mapping and ablation strategy | 12 months | |
Secondary | Overall RF time delivered till SR | • RF time to termination of AF to AT | 12 months | |
Secondary | clinical long term outcome | • Freedom from AF/flutter/tachycardia (> 30 sec) at the end of the 12 months F/U period | 12 months | |
Secondary | Time to first recurrence | • Time to first recurrence of AF/flutter/tachycardia (> 30 sec) | 12 months | |
Secondary | Clinical outcome including drugs | • Freedom of AF/flutter/tachycardia on previously failed anti-arrhythmic medication | 12 months |
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