NCT05771987

Permanent Pacing for Drug-refractory Symptomatic Patients With Obstructive Hypertrophic Cardiomyopathy.

Permanent Pacing as a Treatment for Drug-refractory Symptomatic Patients With Obstructive Hypertrophic Cardiomyopathy.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Istituto Auxologico Italiano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The present trial is undertaken as a pilot study on selected patients, to evaluate the ability of acute hemodynamic testing to optimize pacing therapy and to predict the response of Obstructive Hypertrophic Cardiomyopathy (OHCM) to pacing, in terms of reduction of Left Ventricular Outflow Tract (LVOT) pressure gradient and functional capacity improvement. The Primary Objective is to demonstrate a long-term reduction in LVOT obstruction at rest and/or after Valsalva/Exercise \> 30% in patients responding to acute stimulation test

Conditions

• Obstructive Hypertrophic Cardiomyopathy

Interventions

Type	Name	Description
PROCEDURE	pace maker implant guided by acute hemodynamic testing	To evaluate the ability of acute hemodynamic testing to optimize pacing therapy and to predict the response of HOCM to pacing

Timeline

• Start date: 2018-06-28
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2023-03-16
• Last updated: 2023-03-16

Locations

1 site across 1 country: Italy