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

NCT05771987 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-03-16

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Istituto Auxologico Italiano

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-28
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05771987 on ClinicalTrials.gov