NCT06224621

Brief 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. 1.the treatment efficacy and safety of PESA treatment in oHCM patients with either left ventricular outflow tract obstruction (LVOTO) or midventricular obstruction;
  2. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

January 31, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

May 20, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

January 2, 2024

Last Update Submit

May 16, 2024

Conditions

Obstructive Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • Change in LVOT gradiant/midventricular gradient

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

    6 months,9 months and 12 months

Secondary Outcomes (13)

  • Change in 6 minute walking test

    6 months,9 months and 12 months

  • Change in NYHA cardiac function class

    6 months,9 months and 12 months

  • Change in cTnT

    6 months,9 months and 12 months

  • Change in cTnI

    6 months,9 months and 12 months

  • Change in NT-proBNP

    6 months,9 months and 12 months

  • +8 more secondary outcomes

Study Arms (1)

Study group

EXPERIMENTAL

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

Percutaneous Endocardial Septal Radiofrequency AblationPROCEDURE

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

Study group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100037, China

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Central Study Contacts

Lingmin Wu

CONTACT

18810488351wlmxt2008@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 25, 2024

Study Start

January 31, 2024

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

May 20, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF

Locations

CN(1)