Alcohol Septal Ablation in Obstructive Hypertrophic Cardiomyopathy: A Pilot Study

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00035386
First received: May 2, 2002
Last updated: March 3, 2008
Last verified: April 2003
  Purpose

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.


Condition Intervention Phase
Hypertrophic Cardiomyopathy
Procedure: trans-right ventricular alcohol septal ablation (TRVASA)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: Trans-Right Ventricular Approach to Alcohol Septal Ablation in Obstructive Hypertrophic Cardiomyopathy: A Pilot Feasibility Study

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 12
Study Start Date: April 2002
Estimated Study Completion Date: April 2003
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

Patients of either gender, aged 18-85 years.

Symptomatic patients receiving clinically indicated evaluation for cardiomyopathy and found to have obstructive HCM.

LV outflow tract gradient greater than 30 mm Hg at rest by echocardiography or cardiac catheterization.

EXCLUSION CRITERIA:

Positive pregnancy test.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035386

Locations
United States, Maryland
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00035386     History of Changes
Other Study ID Numbers: 020125, 02-H-0125
Study First Received: May 2, 2002
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Outflow Obstruction
ICE
HCM
Hypertrophic Cardiomyopathy
OHC
Obstructive HCM
Cardiomyopathy

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Pathological Conditions, Anatomical
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014