Percutaneous Endocardial Septal Radiofrequency Ablation in Obstructive Hypertrophic Cardiomyopathy
NCT ID: NCT06224621
Last Updated: 2024-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-01-31
2026-01-31
Brief Summary
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1. the treatment efficacy and safety of PESA treatment in oHCM patients with either left ventricular outflow tract obstruction (LVOTO) or midventricular obstruction;
2. the impact of PESA treatment on the functional capacity, quality of life and long-term prognosis of oHCM patients with either LVOTO or midventricular obstruction.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study group
Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) is used to ablatethe hypertrophied septum of obstructive hypertrophic cardiomyopathy (oHCM) patients.
Percutaneous Endocardial Septal Radiofrequency Ablation
Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) is used to ablatethe hypertrophied septum of obstructive hypertrophic cardiomyopathy (oHCM) patients.
Interventions
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Percutaneous Endocardial Septal Radiofrequency Ablation
Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) is used to ablatethe hypertrophied septum of obstructive hypertrophic cardiomyopathy (oHCM) patients.
Eligibility Criteria
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Inclusion Criteria
* At least 18 years old;
* The presence of a resting or maximum provoked LVOT/midventricular gradient of ≥50 mmHg with symptoms, despite maximum tolerated medical therapy;
* Willing to receive PESA treatment;
* LVEF≥55%;
* Signed and dated written informed consent and willing to return for clinical follow-up.
Exclusion Criteria
* Complete right bundle branch block;
* Acute decompensation heart failure with NYHA IV;
* Previous septal reduction therapy including surgical and interventional procedures;
* Combination of other diseases requiring surgical treatment (including but not limited to coronary artery bypass grafting and apical aneurysm);
* Contraindications of radiofrequency ablation procedure;
* Women who are pregnant or lactating, or who plan to become pregnant while in the trial;
* Currently enrolled in another investigational device or drug trial;
* Combining any other clinical condition with a life expectancy less than 1 year.
18 Years
85 Years
ALL
No
Sponsors
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China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Locations
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Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-ZX012
Identifier Type: -
Identifier Source: org_study_id
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