HCM-AF Ablation With ACUTUS

NCT04090437 | Unknown

• 1 other identifier: ACUTUS-RBH01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation; Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Overall RF time delivered till SR

  12 months

• clinical long term outcome

  12 months

• Time to first recurrence

  12 months

• Clinical outcome including drugs

  12 months

Study Arms (2)

Group1 - PVI first step

ACTIVE COMPARATOR

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

Group2 - PVI last step

ACTIVE COMPARATOR

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

Interventions

Catheter ablation procedure PROCEDURE

Catheter ablation procedure using Acutus mapping system

Group1 - PVI first step; Group2 - PVI last step

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• Acutus Medical: collaborator

MeSH Terms

Conditions

Atrial Fibrillation; Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiomyopathies; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Central Study Contacts

Sabine IS Ernst, MD PhD

CONTACT

+442073518612; s.ernst@rbht.nhs.uk

Edita Sremac-Radivoj

CONTACT

+442073518612; e.sremac-radivoj@rbht.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, double-arm, randomised, observational study that will recruit 20 HCM-AF patients (10 for each group)

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 16, 2019
• Study Start: October 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: February 1, 2021
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share