Search / Trial NCT00001894

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

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Nov 3, 1999

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Trial Information

Current as of December 07, 2023

Completed

Keywords

Hcm Alcohol Septal Ablation Pacemaker

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.

Gender

All

Eligibility 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.

Attachments

readout_NCT00001894_2023-12-07.pdf

4.5 MB

NCT00001894_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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