Clinical Outcomes of PIMSRA Treating for Hypertrophic Obstructive Cardiomyopathy: A Large-Sample Study

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 90 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: Patients who are diagnosed with HOCM and with drug-refractory symptoms underwent PIMSRA in Xijing Hospital from 2016 to 2025.

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Clinical Outcomes of Percutaneous Intramyocardial Septal Radiofrequency Ablation Treating for Hypertrophic Obstructive Cardiomyopathy: A Large-Sample Study

Conditions

Hypertrophic Obstructive Cardiomyopathy (HOCM)

Being tested

Percutaneous Intramyocardial Septal Radiofrequency Ablation

Keywords

Cardiomyopathy, hypertrophic, Treatment outcome, safety, efficacy, Percutaneous intramyocardial septal radiofrequency ablation

Medical subject headings

Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Percutaneous Intramyocardial Septal Radiofrequency AblationProcedure or surgery

  With the real-time guidance of TTE, a radiofrequency electrode needle was percutaneously inserted via the transapical intramyocardial approach into the hypertrophied septum for thermal ablation. Intraoperative TTE and 12-lead electrocardiographic monitoring were employed to assess the ablation extent and prevent vascular and cardiac conduction bundle injury. The success of ablation was confirmed by evaluating contrast medium perfusion defects in the ablated areas and comparing them with the preprocedural hypertrophied septum.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Major adverse cardiovascular events

   Major adverse cardiovascular events including but not limited to:

   1. All-cause death;
   2. Arrhythmic events: resuscitated cardiac arrest or ventricular tachycardia/fibrillation, appropriate implantable cardioverter-defibrillator discharge, atrioventricular block, pacemaker implantation and atrial fibrillation;
   3. Acute heart failure: acute pulmonary edema, new-onset NYHA class Ⅲ-IV symptoms, and heart failure-related hospitalization;
   4. Cardiogenic shock: cardiac disorder that results in a systolic blood pressure <90 mmHg for ≥30 min (or the need for vasopressors, inotropes or mechanical circulatory support to maintain systolic blood pressure ≥90 mmHg) with evidence of hypoperfusion;
   5. Severe systolic anterior motion: the proximal portion of the anterior mitral leaflet moved excessively close to the septum, resulting in extreme LVOT obstruction and acute haemodynamic collapse;
   6. Cerebrovascular events: all stroke (ischemic or hemorrhagic) and transient ischemic attacks.

   Measured: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.

2. Procedure-related adverse events

   Any instrument or procedure-related complications, including but not limited to death, emergency surgery, pericardial tamponade requiring pericardiocentesis or surgery, bleeding, procedure-related stroke.

   Measured: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.

3. Interventricular septal thickness

   Maximum septal thickness as measured by echocardiography.

   Measured: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.

4. Left ventricular outflow tract gradient

   Left ventricular outflow tract gradient as measured by echocardiography.

   Measured: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted4 Jun 2025
2. Study start29 Apr 2025
3. Primary completion30 Jun 2027 (estimated)
4. Study completion30 Jun 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Hypertrophic Obstructive Cardiomyopathy (HOCM)Studies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.