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NCT Number: NCT05610215

Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

After informed consent, 66 eligible admissions will be recruited in 2 centers. Eligible participants will be randomly divided (1:1) into either hybrid or catheter ablation arms, looking for a primary outcome of 1-year freedom from atrial arrhythmias.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Be able to understand the contents of the trial, and provide written informed consent to participate in this investigation.

Exclusion criteria

  • 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
  • Concomitant with a coronary or valvular disease that indicates intervention
  • Ischaemic stroke within 2 months
  • Previous ablation history
  • Uncontrolled hyper/hypothyroidism
  • End-staged kidney failure
  • Concomitantly involved in other trials
  • Pregnant or breastfeeding, or women of childbearing age not using a reliable contraceptive method
  • Concomitant with bacteremia or at an active phase of infection
  • Anatomically not suitable for thoracoscopic surgery(history of chest surgery or radiotherapy, etc.)
  • Unwilling or unable to comply with all peri-ablation and follow-up requirements

Treatment and study plan

Hybrid Ablation

Procedure

simultaneous thoracoscopic epicardial and catheter endocardial ablation

Catheter ablation

Procedure

catheter endocardial ablation

Primary outcomes

  1. Freedom from documented recurrence (off-AADs)

    Time frame: within 3-12 months

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

Secondary outcomes

  1. All cause mortality

    Time frame: within 12 months

    death by any reason

  2. Cardiovascular related mortality

    Time frame: within 12 months

    death that related to cardiogenic causes

  3. Cerebral infarction/ischemia

    Time frame: within 12 months

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

  4. Periferal arterial embolism

    Time frame: within 12 months

    Periferal arterial embolism

  5. All-cause rehospitalization

    Time frame: within 3-12 months

    Rehospitalized by any reason

  6. Heart failure related rehospitalization

    Time frame: within 3-12 months

    Rehospitalized by the cause of heart failure episode

  7. Freedom from documented recurrence (on-AADs)

    Time frame: within 3-12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yajie Tang, MD.PhD

CONTACT

[email protected]

+8618813019554

Zhe Zheng, MD.PhD

CONTACT

[email protected]

+86-010-88396051

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

Concomitant Hybrid Versus Catheter Ablation for Reinforcing Therapeutic Effect of Atrial Fibrillation With Hypertrophic Cardiomyopathy

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 9, 2022
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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