Percutaneous Endocardial Septal Radiofrequency Ablation in Obstructive Hypertrophic Cardiomyopathy

May 16, 2024 updated by: China National Center for Cardiovascular Diseases

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) is used to ablatethe hypertrophied septum of obstructive hypertrophic cardiomyopathy (oHCM) patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in LVOT gradiant/midventricular gradient
Time Frame: 6 months,9 months and 12 months
Change in Left ventricular outflow tract gradient pre- and post- intervention
6 months,9 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6 minute walking test
Time Frame: 6 months,9 months and 12 months
Change in 6 minute walking distance pre- and post- intervention
6 months,9 months and 12 months
Change in NYHA cardiac function class
Time Frame: 6 months,9 months and 12 months
A system used to categorize the severity of heart failure based on the functional limitations of individuals.
6 months,9 months and 12 months
Change in cTnT
Time Frame: 6 months,9 months and 12 months
Cardiac biomarker
6 months,9 months and 12 months
Change in cTnI
Time Frame: 6 months,9 months and 12 months
Cardiac biomarker
6 months,9 months and 12 months
Change in NT-proBNP
Time Frame: 6 months,9 months and 12 months
Cardiac biomarker
6 months,9 months and 12 months
Change in Participant-reported Health-related Quality of Life as Assessed by the KCCQ Score
Time Frame: 6 months,9 months and 12 months
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
6 months,9 months and 12 months
Change in Left ventricular ejection fraction (LVEF)
Time Frame: 6 months,9 months and 12 months
LVEF measured by echocardiography
6 months,9 months and 12 months
Change in Left ventricular end-diastolic diameter (LVEDD)
Time Frame: 6 months,9 months and 12 months
LVEDD measured by echocardiography
6 months,9 months and 12 months
Change in Left atrial diameter (LAD)
Time Frame: 6 months,9 months and 12 months
LAD measured by echocardiography
6 months,9 months and 12 months
Change in Maximal wall thickness (MWT)
Time Frame: 6 months,9 months and 12 months
MWT measured by echocardiography
6 months,9 months and 12 months
Change in Left ventricular mass index (LVMi)
Time Frame: 6 months,9 months and 12 months
LVMi measured by cardiac magnetic resonance
6 months,9 months and 12 months
Change in Late gadolinium enhancement (LGE)
Time Frame: 6 months,9 months and 12 months
LGE measured by cardiac magnetic resonance
6 months,9 months and 12 months
Change in Cardiac index (CI)
Time Frame: 6 months,9 months and 12 months
CI measured by cardiac magnetic resonance
6 months,9 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2024

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-ZX012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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