- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04902079
Observational and Prospective Registry on Cardiac Contractility Modulation (CCM) Therapy (REPORT-CCM)
June 2, 2021 updated by: Antonio D'Onofrio, Monaldi Hospital
Observational and perspective study with acute and chronic endpoint.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This registry includes patients who have undergone implantation of the cardiac contractility modulation device due to the presence of heart failure with reduced left ventricular systolic function and symptomatic despite optimal therapy, as indicated in the guidelines of the ESC of 2016 and the Expert Consensus Document of the ESC Heart Failure group published in May 2019 for to assess the benefits after the CCM device.
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Antonio D'Onofrio, MD
- Phone Number: 337768956
- Email: donofrionat1@gmail.com
Study Contact Backup
- Name: Giuliano D'Alterio, MD
- Phone Number: 3332785271
- Email: gdalterio@libero.it
Study Locations
-
-
-
Naples, Italy, 80131
- Recruiting
- Monaldi Hospital
-
Contact:
- Antonio D'Onofrio, MD
- Email: donofrioant1@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with standard indication to CardiaC Contractility Modulation (CCM) therapy device system implantation
Description
Inclusion Criteria:
- Male or non-pregnant female, aged 18 or older;
- chronic heart failure with symptomatic left ventricular systolic function; (NYHA class II-IVa) with or without device already implanted (for example AICD, pace-maker);
- Appropriate and optimized medical therapy
- Patient signed and dated informed consent form at enrollment;
- life expectancy> 1 year due to the absence of comorbidities that reduce the prognosis
Exclusion Criteria:
- absence of venous access available for implant;
- contraindication to the interventional procedure of CCM device implant (for example presence of Mechanical tricuspid vale);
- pregnant patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement Quality of Life
Time Frame: 12 months
|
Evaluatation of the impact on CCM Therapy on Quality of Life evaluated from the reduction of MLWHFQ score at FU post implant of CCM device compared to baseline
|
12 months
|
Functional Capacity
Time Frame: 12 months
|
Evaluation of the impact on CCM Therapy on Functional Capacity evaluated from the gain of distance traveled in the 6MWT at FU post implant of CCM device compared to baseline
|
12 months
|
Reduction of HF Hospitalizations and Emergency Ward accesses
Time Frame: 12 months
|
Reduction of HF Hospitalizations and Emergency Ward accesses at FU post implant of CCM device compared to number of HF hospitalization an Emergency Ward accesses collected 1 year before the implant of CCM therapy
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Antonio D'Onofrio, MD, AO dei Colli - Monaldi Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 8, 2021
Primary Completion (Anticipated)
June 30, 2022
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
May 15, 2021
First Submitted That Met QC Criteria
May 20, 2021
First Posted (Actual)
May 26, 2021
Study Record Updates
Last Update Posted (Actual)
June 3, 2021
Last Update Submitted That Met QC Criteria
June 2, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCM-001Mon
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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