Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this trial

The goal of this clinical trial is to compare the rhythm control effect in hypertrophic non-obstructive patients with non-paroxysmal atrial fibrillation by either concomitant catheter endocardial and thoracoscopic epicardial ablation or catheter ablation alone. The study aims to see if concomitant hybrid ablation can more effectively achieve rhythm control effect than catheter ablation alone in non-paroxysmal atrial fibrillation patients with hypertrophic cardiomyopathy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients' age is ≥18 y

Clinically diagnosed hypertrophic cardiomyopathy (any left ventricular wall segment thickness ≥15 mm in genetical negative (or unknown genetical status) patients or ≥13mm in genetical positive ones-as measured by any imaging technique (echocardiography, cardiac magnetic resonance imaging or computed tomography)-that is not explained solely by loading conditions)

Non-obstructed left ventricular outflow obstruction with peak gradients <30mmHg

Concomitant with persistent atrial fibrillation (7 days<sustained episode lasting<3 years) with drug-refractory symptoms.

Disqualifiers

Patients with left atrial size >60 mm (2-dimensional echocardiography, parasternal long-axis view)

Contraindicated to systemic anticoagulation

Left ventricular ejection fraction ≤40%

Concomitant with left atrium or left atrial appendage emboli

Trial design

Design model

Parallel

Treatments tested in this trial

  • hybrid ablation

    Procedure/Surgery

    simultaneous thoracoscopic epicardial and catheter endocardial ablation

  • catheter ablation

    Procedure/Surgery

    catheter endocardial ablation

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: hybrid ablationExperimental treatment 1 intervention
Group B: catheter ablationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Freedom from documented recurrence (off-AADs)

freedom from documented AF/AT episodes \>30 seconds (off-AADs) by 72-hour holter monitoring

Time frame
within 3-12 months

Secondary outcomes

1

All cause mortality

death by any reason

Time frame
within 12 months
2

Cardiovascular related mortality

death that related to cardiogenic causes

Time frame
within 12 months
3

Cerebral infarction/ischemia

Any stroke or TIA diagnosed in the clinical record after the completion of the intervention

Time frame
within 12 months
4

Periferal arterial embolism

Periferal arterial embolism

Time frame
within 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.