Status:

ACTIVE_NOT_RECRUITING

Echocardiography-guided Percutaneous Septal Radiofrequency Ablation for Obstructive HCM After Alcohol Septal Ablation

Lead Sponsor:

Xijing Hospital

Conditions:

Hypertrophic Cardiomyopathy

Eligibility:

All Genders

18-80 years

Brief Summary

After alcohol ablation, some HOCM patients have serious clinical symptoms and adverse complications, and need to undergo invasive surgery again when adequate drug therapy is not effective or cannot to...

Detailed Description

Hypertrophic cardiomyopathy (HCM) is the most common inherited cardiovascular disease, mostly due to mutations in the gene encoding myocardial sarcomere contractile protein, with an incidence of about...

Eligibility Criteria

Inclusion

  • The patient is at least 18 years of age.
  • Hypertrophic cardiomyopathy with alcohol ablation, LVOT pressure difference at rest or after excitation ≥ 50mmHg;
  • The clinical symptoms are obvious, fatigue, shortness of breath, exhaustive angina pectoris, syncope, etc. seriously affect the quality of life, and the effect of adequate drug treatment is not good or the side effects of drugs cannot be tolerated;
  • After the informed consent of the patient and his family, he voluntarily underwent Liwen surgery.

Exclusion

  • Non-obstructive hypertrophic cardiomyopathy;
  • Left ventricular hypertrophy due to secondary causes, such as increased preload, history of taking drugs suspected of causing left ventricular hypertrophy, etc.
  • Preoperative complications with other heart diseases require surgical treatment.
  • The disease will make it difficult to evaluate treatment (e.g. cancer, severe metabolic diseases, mental illness, etc.).
  • Patients who have participated in any clinical trial of drugs and/or medical devices within 1 month before surgery or during follow-up;
  • Pregnant and breastfeeding women;
  • Patients with poor adherence may not cooperate during treatment or follow-up.

Key Trial Info

Start Date :

March 26 2024

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 31 2024

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT06496633

Start Date

March 26 2024

End Date

December 31 2024

Last Update

July 11 2024

Active Locations (1)

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Ultrasonic Diagnosis Department of Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China, 710032