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HCM-AF Ablation With ACUTUS

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ClinicalTrials.gov Identifier: NCT04090437
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
Acutus Medical
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

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 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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Hypertrophic Cardiomyopathy Procedure: Catheter ablation procedure Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, double-arm, randomised, observational study that will recruit 20 HCM-AF patients (10 for each group)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dipole Intracardiac Mapping With ACUTUS System for Catheter Ablation of Atrial Fibrillation in Hypertrophic Cardiomyopathy
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : February 1, 2021


Arm Intervention/treatment
Active Comparator: Group1 - PVI first step

Catheter ablation procedure:

Dipole map of RA and LA at baseline (5 times for both, each for 20sec, +/- Adenosine IV)

  • PVI as first step
  • Remap to assess any change in activation
  • Ablate all rotors (API) in LA until SR or DCCV
  • Deployment of RA CTI line and demonstration of bidirectional block
Procedure: Catheter ablation procedure
Catheter ablation procedure using Acutus mapping system

Active Comparator: Group2 - PVI last step

Catheter ablation procedure:

Dipole map of RA and LA at baseline (5 times for both, each for 20sec, +/- Adenosine IV)

  • Ablate all rotors (API) in LA until SR or DCCV
  • Remap to assess any change in activation
  • PVI as last step even when SR achieved earlier
  • Deployment of RA CTI line and demonstration of bidirectional block
Procedure: Catheter ablation procedure
Catheter ablation procedure using Acutus mapping system




Primary Outcome Measures :
  1. Clinical efficacy to achieve SR defined as time (in minutes) to termination of AF into stable SR [ Time Frame: 12 months ]
    • 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

  2. Acute procedural safety assessed by incidence (number and type) of acute procedure-related Adverse Events [ Time Frame: 12 months ]
    • Absence of acute adverse events due to the use of ACUTUS mapping system during AF ablation

  3. Chronic procedural safety assessed by incidence (number and type) of chronic procedure-related Adverse Events [ Time Frame: 12 months ]
    • Evidence of chronic adverse events due to the use of ACUTUS mapping system guided catheter ablation during the 12 months F/U period

  4. 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 [ Time Frame: 12 months ]
    • Safety endpoint of the entire mapping and ablation strategy


Secondary Outcome Measures :
  1. Overall RF time delivered till SR [ Time Frame: 12 months ]
    • RF time to termination of AF to AT

  2. clinical long term outcome [ Time Frame: 12 months ]
    • Freedom from AF/flutter/tachycardia (> 30 sec) at the end of the 12 months F/U period

  3. Time to first recurrence [ Time Frame: 12 months ]
    • Time to first recurrence of AF/flutter/tachycardia (> 30 sec)

  4. Clinical outcome including drugs [ Time Frame: 12 months ]
    • Freedom of AF/flutter/tachycardia on previously failed anti-arrhythmic medication



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090437


Contacts
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Contact: Sabine IS Ernst, MD PhD +442073518612 s.ernst@rbht.nhs.uk
Contact: Edita Sremac-Radivoj +442073518612 e.sremac-radivoj@rbht.nhs.uk

Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Acutus Medical

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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04090437     History of Changes
Other Study ID Numbers: ACUTUS-RBH01
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases