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Percutaneous Endocardial Septal Radiofrequency Ablation in the Treatment of Hypertrophic Obstructive Cardiomyopathy: a Prospective, Multicenter, Single-arm Objective Performance Criteria Trial

Percutaneous Endocardial Septal Radiofrequency Ablation in the Treatment of Hypertrophic Obstructive Cardiomyopathy: a Prospective, Multicenter, Single-arm Objective Performance Criteria Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300079220
Enrollment
Unknown
Registered
2023-12-27
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic cardiomyopathy

Interventions

Study group:PESA treatment

Sponsors

Fuwai Hospital, CAMS
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

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

MeasureTime frame
Reduction in LVOT gradiant/midventricular gradient;

Secondary

MeasureTime frame
6 minute walking test;NYHA;NTproBNP;cTnI;cTnT;KCCQ-(CSS);Transthoracic echocardiographic parameters;Cardiac magnetic resonance parameters;

Countries

China

Contacts

Public ContactLingmin Wu

Fuwai Hospital, CAMS&PUMC

wlmxt2008@126.com+86 188 1048 8351

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026