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HCM-AF Ablation With ACUTUS

NCT04090437 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-09-19

No results posted yet for this study

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

Interventions

PROCEDURE

Catheter ablation procedure

Catheter ablation procedure using Acutus mapping system

Sponsors & Collaborators

  • Acutus Medical

    collaborator INDUSTRY

  • Royal Brompton & Harefield NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2020-06-30
Completion
2021-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04090437 on ClinicalTrials.gov