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

Keywords

ClinConnect Summary

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.