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CCM in Heart Failure With Preserved Ejection Fraction

NCT03240237 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-04-23

No results posted yet for this study

Summary

This pilot study will evaluate the efficacy and safety of CCM therapy in heart failure patients with baseline EF≥50% (HFpEF) who have New York Heart Association (NYHA) Class II or III symptoms despite appropriate medication.

The terminology of the HF classification HFpEF is based on the 2016 European Society of Cardiology (ESC) Heart Failure Guidelines.

Conditions

  • Heart Failure, Diastolic

Interventions

DEVICE

Optimizer SMART

Cardiac Contractility Modulation

Sponsors & Collaborators

  • Impulse Dynamics

    lead INDUSTRY

Principal Investigators

  • Carsten Tschoepe, Prof. · University Hospital Charite Berlin

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2023-07-25
Completion
2023-07-25

Countries

  • Australia
  • Czechia
  • Germany
  • Italy
  • Poland
  • Portugal
  • Spain
  • Sweden

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 NCT03240237 on ClinicalTrials.gov