Hypertrophic cardiomyopathy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with a diagnosis of hypertrophic cardiomyopathy; 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
Exclusion criteria: Midventricular obstruction rendered by isolated papillary muscle hypertrophy; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in LVOT gradiant/midventricular gradient; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6 minute walking test;NYHA;NTproBNP;cTnI;cTnT;KCCQ-(CSS);Transthoracic echocardiographic parameters;Cardiac magnetic resonance parameters; | — |
Countries
China
Contacts
Fuwai Hospital, CAMS&PUMC