Viewing Study NCT00035386



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Last Modification Date: 2024-10-26 @ 9:07 AM
Study NCT ID: NCT00035386
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 2002-05-02

Brief Title: Alcohol Septal Ablation in Obstructive Hypertrophic Cardiomyopathy A Pilot Study
Sponsor: National Heart Lung and Blood Institute NHLBI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Trans-Right Ventricular Approach to Alcohol Septal Ablation in Obstructive Hypertrophic Cardiomyopathy A Pilot Feasibility Study
Status: COMPLETED
Status Verified Date: 2003-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study will test the feasibility of a modified procedure for treating obstructive hypertrophic cardiomyopathy OHC Patients with OHC have a thickening of the heart muscle that obstructs blood flow out of the heart causing breathlessness chest pain palpitations tiredness lightheadedness and fainting

The current treatment for OHC is a procedure called alcohol septal ablation also percutaneous transluminal septal ablation or PTSA which involves injecting a small amount of alcohol into a tiny artery that supplies the part of muscle causing blood flow obstruction The success of PTSA is limited however by problems of heart anatomy and the ability to find the appropriate artery to inject Modifying the procedure by injecting the alcohol through the wall of the lower right chamber of the heart may improve its safety and effectiveness The new technique requires positioning a catheter a flexible tube into the appropriate area of the heart This study will test the ability to accurately guide the catheter to that area

Patients with OHC 18 years of age and older who are scheduled to have a cardiac catheterization may be eligible for this study At the end of the catheterization procedure participants will undergo intra-cardiac echocardiographic imaging For this test one of the catheters placed in the femoral artery at the top of the leg for cardiac catheterization will be substituted for a larger one Through this catheter a special catheter will be introduced and advanced to the heart to provide images This pilot feasibility study does not involve injection of alcohol
Detailed Description: Patients with obstructive hypertrophic cardiomyopathy HCM and drug-refractory symptoms have traditionally been referred for cardiac surgery to widen the left ventricular LV outflow tract More recently percutaneous transluminal septal ablation PTSA has also been shown to thin the subvalvular septum and thereby to reduce LV outflow pressure gradients and to improve symptoms in obstructive HCM However this procedure is not infrequently limited by septal coronary artery anatomy and inability to identify and cannulate the appropriate artery that supplies the septal region of interest Some attempts are also associated with coronary artery dissection particularly if there is associated coronary artery disease A trans-right ventricular RV alcohol septal ablation TRVASA would significantly simplify the procedure and increase its safety The purpose of this study is to initially test our ability to visualize and guide a delivery catheter to a targeted part of the anterior interventricular septum involved in the generation of the LV outflow obstruction using intracardiac echocardiography ICE No therapy is intended alcohol will not be injected into the septum in this initial study

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
02-H-0125 None None None