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A Comparison of Two Treatments: Pacemaker and Percutaneous Transluminal Septal Ablation for Hypertrophic Cardiomyopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001894
First Posted: November 4, 1999
Last Update Posted: January 23, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

This study will compare two treatments: pacemaker implantation and percutaneous transluminal septal ablation (PTSA) for patients with hypertrophic cardiomyopathy (HCM), a condition in which the heart muscle thickens and obstructs the flow of blood out of the heart. The reduced blood flow can cause chest pain, shortness of breath, palpitations, tiredness, lightheadedness and fainting.

Patients with HCM who cannot be helped by drug therapy may participate in the study. The standard treatment for such patients is septal myectomy, an operation in which the surgeon shaves the muscle obstructing the blood flow. Another treatment option is implantation of a type of pacemaker that causes the heart to contract in a certain way that reduces blood flow obstruction and improves symptoms. The pacemaker is implanted under local anesthesia and usually takes less than an hour. PTSA is an experimental treatment that may provide a third option. In PTSA, a thin tube (catheter) is inserted into the blood vessel that feeds the heart muscle causing the blood flow obstruction. A small amount of alcohol is injected through the catheter to destroy some of the muscle and relieve the obstruction.

Candidates will have the following screening tests: chest X-ray, electrocardiogram, echocardiogram, exercise tests, exercise radionuclide angiography, exercise thallium scintigraphy, Holter monitoring, cardiac catheterization, electrophysiology study, and coronary angiography. Participants will be assigned to one of the two treatments groups: pacemaker implantation or PTSA. Patients in the PTSA group will also have magnetic resonance imaging scans at the start of the study, 3 to 7 days after PTSA, and at the end of the study, in order to observe changes in the heart's shape. All patients will fill out a questionnaire answering questions about their quality of life.

Patients' progress will be followed with monthly phone calls. In addition, various tests, such as exercise tests and echocardiography, will be done during repeat visits at three and six months to measure treatment results. Patients will again complete quality-of-life questionnaires at both of those visits.


Condition Intervention Phase
Hypertrophic Cardiomyopathy Procedure: pacemaker implantation Procedure: percutaneous transluminal septal ablation (PTSA) Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Randomized Prospective Comparison of DDD Chamber Pacing and Percutaneous Transluminal Septal Ablation in Obstructive Hypertrophic Cardiomyopathy Associated With Severe Drug-Refractory Symptoms

Resource links provided by NLM:


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

Estimated Enrollment: 70
Study Start Date: August 1999
Estimated Study Completion Date: September 2002
Detailed Description:
Patients with obstructive HCM and drug-refractory symptoms are referred for left ventricular myotomy and myectomy (LVMM) or mitral valve replacement. As alternative therapies to cardiac surgery, we propose to compare the abilities of dual chamber (DDD) pacing and percutaneous transluminal septal ablation (PTSA) to reduce left ventricular (LV) outflow pressure gradients and to improve exercise performance in patients with obstructive HCM and severe symptoms who have failed to benefit from pharmacotherapy.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patients of either gender, aged 18-80 years.

NYHA functional class III/IV, or syncope, or greater than or equal to 2 presyncope despite verapamil and/or Beta-blocker therapy.

LV outflow tract gradient greater than or equal to 30 mm Hg at rest or greater than or equal to 50 mm Hg following isoproterenol infusion to a heart rate of greater than 100 bpm.

No patients with mid-cavity obstructive HCM.

No patients with LV septal wall thickness less than 15 mm estimated by echocardiography.

No patients with greater than 50 percent luminal narrowing in a major coronary artery vessel.

No patients with chronic atrial fibrillation.

No patients with a positive pregnancy test.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001894


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

Publications:
ClinicalTrials.gov Identifier: NCT00001894     History of Changes
Other Study ID Numbers: 990150
99-H-0150
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: January 23, 2007
Last Verified: September 2002

Keywords provided by National Institutes of Health Clinical Center (CC):
HCM
Alcohol
Septal Ablation
Pacemaker

Additional relevant MeSH terms:
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases