Alcohol Septal Ablation in Obstructive Hypertrophic Cardiomyopathy: A Pilot Study

NCT00035386 | Completed Phase 2

• 2 other identifiers: 02012502-H-0125
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Cardiomyopathy

Keywords

Outflow Obstruction; ICE; HCM; Hypertrophic Cardiomyopathy; OHC; Obstructive HCM; Cardiomyopathy

Interventions

trans-right ventricular alcohol septal ablation (TRVASA) PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Positive pregnancy test.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• McIntosh CL, Maron BJ. Current operative treatment of obstructive hypertrophic cardiomyopathy. Circulation. 1988 Sep;78(3):487-95. doi: 10.1161/01.cir.78.3.487. No abstract available.

  PMID: 3409494 BACKGROUND

• Krajcer Z, Leachman RD, Cooley DA, Coronado R. Septal myotomy-myomectomy versus mitral valve replacement in hypertrophic cardiomyopathy. Ten-year follow-up in 185 patients. Circulation. 1989 Sep;80(3 Pt 1):I57-64.

  PMID: 2766539 BACKGROUND

• Delahaye F, Jegaden O, de Gevigney G, Genoud JL, Perinetti M, Montagna P, Delaye J, Mikaeloff P. Postoperative and long-term prognosis of myotomy-myomectomy for obstructive hypertrophic cardiomyopathy: influence of associated mitral valve replacement. Eur Heart J. 1993 Sep;14(9):1229-37. doi: 10.1093/eurheartj/14.9.1229.

  PMID: 8223738 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Cardiomyopathies

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 2, 2002
• First Posted: May 3, 2002
• Study Start: April 1, 2002
• Study Completion: April 1, 2003
• Last Updated: March 4, 2008

Record last verified: 2003-04

Locations

US (1)