First-in-Man Early Feasibility Study for Transcatheter HOCM Septal Ablation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-21

Study Completion Date

2025-04-08

Brief Summary

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Transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices) to treat hypertrophic obstructive cardiomyopathy.

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Detailed Description

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The objective of this multi-center, open label, single arm, investigator initiated exploratory pilot study is to evaluation of safety and efficacy of transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices), in treating hypertrophic obstructive cardiomyopathy(HOCM).

Conditions

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Hypertrophic Obstructive Cardiomyopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

multi-center, open label, single arm, investigator initiated exploratory pilot study

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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TIRA

treated with transcatheter RF ablation system (TIRA catheter with its supplemental devices)

Group Type EXPERIMENTAL

TIRA catheter

Intervention Type DEVICE

treat hypertrophic obstructive cardiomyopathy

Interventions

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TIRA catheter

treat hypertrophic obstructive cardiomyopathy

Intervention Type DEVICE

Other Intervention Names

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CA10 and ohter 3 models

Eligibility Criteria

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Inclusion Criteria

* Males and females aged 20 years or older
* NYHA(New York Heart Association) Class Ⅱ to Ⅳ in spite of optimal medical treatment. (For optimal medical treatment, β-blocker or diuretic such as calcium antagonists should be given for at least 3 months.)
* Patients with left ventricular effusion gradient (LVOT) greater than (1) 30 mmHg at rest or (2) at least 50 mmHg at physiological exercise/dobutamine administration/balsalva manuver. (The pressure difference due to the left ventricle drain must be the proximal mitral valve-septal contact by the systolic motion of mitral valve (SAM).)
* Patients who voluntarily decide to participate in this clinical trial and provide written informed consent.
* Patients who are able to understand and follow instructions and participate for the entire duration of the clinical trial.

Exclusion Criteria

* Target area wall thickness ≤15mm
* LV ejection fraction ≤40%
* Subjects who have unsuitable septal vein and coronary sinus anatomy by cardiac CT or venogram
* Conduction disturbance; LBBB or RBBB
* Advanced AV block without permanent pacemaker
* Subjects who have experience in performing vascular stent procedures (PCI) or CABG on coronary arteries close to the coronary sinus within 3 months.
* Severe pulmonary HTN ≥70mmHg
* Patients who have cardiogenic shock and those who have an expected life expectancy of 12 months or less.
* Patients with other valve diseases (companion disease) that require surgical treatment (in this case, Systolic motion of the mitral valve (SAM) caused by systolic myocardia is not considered a companion disease).
* Patients who are pregnant, or lactating, or plan pregnacy during the clinical trials
* Patients who are participated in other clinical trials within 1 month of enrollment
* Patients who are deemed not to be eligible in this study by physician's discretion

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No