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

China National Center for Cardiovascular Diseases1 site in 1 country120 target enrollmentJanuary 31, 2024

ConditionsObstructive Hypertrophic Cardiomyopathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obstructive Hypertrophic Cardiomyopathy
Sponsor: China National Center for Cardiovascular Diseases
Enrollment: 120
Locations: 1
Primary Endpoint: Change in LVOT gradiant/midventricular gradient
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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:

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

Registry

clinicaltrials.gov

Start Date

January 31, 2024

End Date

January 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

China National Center for Cardiovascular Diseases

Responsible Party

Sponsor

Eligibility 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

•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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

Change in Maximal wall thickness (MWT)(6 months,9 months and 12 months)
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 Left ventricular end-diastolic diameter (LVEDD)(6 months,9 months and 12 months)
Change in Left atrial diameter (LAD)(6 months,9 months and 12 months)
Change in Cardiac index (CI)(6 months,9 months and 12 months)
Change in Late gadolinium enhancement (LGE)(6 months,9 months and 12 months)
Change in Participant-reported Health-related Quality of Life as Assessed by the KCCQ Score(6 months,9 months and 12 months)
Change in NT-proBNP(6 months,9 months and 12 months)
Change in Left ventricular ejection fraction (LVEF)(6 months,9 months and 12 months)
Change in Left ventricular mass index (LVMi)(6 months,9 months and 12 months)