Cardiac Contractility Modulation (CCM) and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY

The primary objective of this study is to evaluate the impact of Cardiac Contractility Modulation (CCM) therapy on the initiation and up-titration of Guideline-Directed Medical Therapy (GDMT) in patients with heart failure (HF). This will be assessed by the change in Quad Medication Score (QMS) from baseline (pre-CCM) to 6-month following post-CCM device implant.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults (≥18 years) diagnosed with symptomatic heart failure

• Patients with Heart failure with reduced Ejection Fraction (HFrEF) where the Ejection Fraction (EF) is ≤40%

• \- Historical LVEF assessed up to 6 months prior to consent by any modality can be used if available

• Patients can have an active concomitant CRT device already - implanted provided the following criteria:

‣ CRT device has been implanted \>1 year

⁃ Patients are functional class NYHA III-IV

Locations
Other Locations
Italy
AO dei Colli - O.Monaldi
RECRUITING
Napoli
Gemelli University Hospital
RECRUITING
Rome
Contact Information
Primary
Gary Cranke
gcranke@impulsedynamics.com
(856) 642-9933
Backup
Rachael Riccitello
rriccitello@impulsedynamics.com
(856) 642-9933
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 200
Related Therapeutic Areas
Sponsors
Leads: Impulse Dynamics

This content was sourced from clinicaltrials.gov