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The Predictive Value of Dobutamine Echo-stress in the Clinical Response to CCM Therapy in Advanced HF

NCT06973902 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-07-29

No results posted yet for this study

Summary

The goal of this observational cohort study, which is both retrospective and prospective, is to evaluate the long-term clinical and instrumental response to Cardiac Contractility Modulation (CCM) treatment in adult subjects suffering from symptomatic heart failure (HF) due to systolic left ventricular dysfunction, despite adequate medical therapy. Based on the response to stress echocardiography with preimplantation low-dose Dobutamine, the main questions it aims to answer are:

* What is the proportion of subjects who experience a clinical response to CCM therapy at 12 months (NYHA reduction ≥ 1 class)?
* There was a reduction in the number of hospitalizations, visits to the Emergency Department, and access to day hospital facilities for more than 4 hours compared to the year before the study (e.g., by intravenous infusion of cardiac inotropic drugs)?
* What is the estimated change in the quality-of-life score using the "Quality of Life Questionnaire with Heart Failure - Minnesota" (MLHFQ) between baseline and the end of follow-up?
* What is the change in walking distance between baseline and the end of the follow-up in the walk test (6MWT) (optional)?
* What is the difference in NT-proBNP levels between baseline and the end of follow-up? Participants are already receiving CCM support as part of their regular medical care for heart failure.

Conditions

  • Symptomatic Congestive Heart Failure

Interventions

DEVICE

Cardiac Contractility Modulation (CCM) implant

Subjects participating in the study carry or will carry the Cardiac Contractility Modulation (CCM) medical device "OPTIMIZER Smart Mini" by Impulse Dynamics (USA). It is indicated for use in patients over 18 years of age with symptomatic heart failure due to systolic left ventricular dysfunction, despite appropriate medical treatment. The OPTIMIZER Smart Mini Implantable Pulse Generator is a programmable device with an internal battery and telemetry functions. The OPTIMIZER Smart Mini is connected to two or three implantable leads, two of which are implanted in the right ventricle and one, optionally, in the right atrium.

Sponsors & Collaborators

  • Impulse Dynamics

    collaborator INDUSTRY

  • Quovadis Associazione

    lead OTHER

Principal Investigators

  • Francesco Zanon, MD · UO Cardiologia, S. Maria della Misericordia Hospital, ULSS5 Polesana, Rovigo (I)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-10
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • Italy

Study Locations

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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 NCT06973902 on ClinicalTrials.gov