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RecruitingNCT06224621Updated May 20, 2024

Percutaneous Endocardial Septal Radiofrequency Ablation in Obstructive Hypertrophic Cardiomyopathy

An interventional study of Percutaneous Endocardial Septal Radiofrequency Ablation in Obstructive Hypertrophic Cardiomyopathy, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-05-20.

Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

This prospective, multicenter, single-arm objective performance criteria trial is designed to assess the efficacy and safety of the Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) procedure in the treatment of obstructive hypertrophic cardiomyopathy (oHCM). The primary objectives include investigating:

  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.
02

Conditions studied

  • Obstructive Hypertrophic Cardiomyopathy
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's planned enrollment of 120 is above the median of 51 across 609 interventional studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Study group

    Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) is used to ablatethe hypertrophied septum of obstructive hypertrophic cardiomyopathy (oHCM) patients.

    Procedure: Percutaneous Endocardial Septal Radiofrequency Ablation

Interventions

  • ProcedurePercutaneous Endocardial Septal Radiofrequency Ablation

    Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) is used to ablatethe hypertrophied septum of obstructive hypertrophic cardiomyopathy (oHCM) patients.

06

What researchers measure

Primary outcomes

  1. Change in LVOT gradiant/midventricular gradient

    Change in Left ventricular outflow tract gradient pre- and post- intervention

    Time frame: 6 months,9 months and 12 months

Secondary outcomes

  1. Change in 6 minute walking test

    Change in 6 minute walking distance pre- and post- intervention

    Time frame: 6 months,9 months and 12 months

  2. Change in NYHA cardiac function class

    A system used to categorize the severity of heart failure based on the functional limitations of individuals.

    Time frame: 6 months,9 months and 12 months

  3. Change in cTnT

    Cardiac biomarker

    Time frame: 6 months,9 months and 12 months

  4. Change in cTnI

    Cardiac biomarker

    Time frame: 6 months,9 months and 12 months

  5. Change in NT-proBNP

    Cardiac biomarker

    Time frame: 6 months,9 months and 12 months

  6. Change in Participant-reported Health-related Quality of Life as Assessed by the KCCQ Score

    The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a patient reported outcome instrument with minimum score = 0 and maximum score = 100 where higher score indicates better health status. There are no units to the score. The instrument utilizes a recall period of 2 weeks over which patients describe the frequency and severity of their symptoms, their physical and social limitations, and how they perceive their heart failure symptoms to affect their quality of life. quality of life

    Time frame: 6 months,9 months and 12 months

  7. Change in Left ventricular ejection fraction (LVEF)

    LVEF measured by echocardiography

    Time frame: 6 months,9 months and 12 months

  8. Change in Left ventricular end-diastolic diameter (LVEDD)

    LVEDD measured by echocardiography

    Time frame: 6 months,9 months and 12 months

  9. Change in Left atrial diameter (LAD)

    LAD measured by echocardiography

    Time frame: 6 months,9 months and 12 months

  10. Change in Maximal wall thickness (MWT)

    MWT measured by echocardiography

    Time frame: 6 months,9 months and 12 months

  11. Change in Left ventricular mass index (LVMi)

    LVMi measured by cardiac magnetic resonance

    Time frame: 6 months,9 months and 12 months

  12. Change in Late gadolinium enhancement (LGE)

    LGE measured by cardiac magnetic resonance

    Time frame: 6 months,9 months and 12 months

  13. Change in Cardiac index (CI)

    CI measured by cardiac magnetic resonance

    Time frame: 6 months,9 months and 12 months

07

Study locations

1 of 1 sites recruiting
  • Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
    Beijing, 100037, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06224621
Lead sponsor
China National Center for Cardiovascular Diseases
Responsible party
Sponsor
First posted
Jan 25, 2024
Start date
Jan 31, 2024
Primary completion
Jan 31, 2026 (estimated)
Completion
Jan 31, 2026 (estimated)
Last update
May 20, 2024

Study contacts

Lingmin Wu
Contact
wlmxt2008@126.com
18810488351

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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