Cardiac Resynchronization Therapy Clinical Trial
— IMAGE-CRTOfficial title:
Impact of MultiPoint Pacing Technology in CRT Patients With Reduced RV-to-LV Delay
| NCT number | NCT02713308 |
| Other study ID # | MP001 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2017 |
| Est. completion date | April 2021 |
| Verified date | March 2020 |
| Source | Monaldi Hospital |
| Contact | Antonio D'Onofrio, MD |
| donofrioant1[@]gmail.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Observational, retrospective and perspective study with acute and chronic endpoints
| Status | Recruiting |
| Enrollment | 248 |
| Est. completion date | April 2021 |
| Est. primary completion date | September 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - Indication to CRT-D system implantation according to current guidelines or CRT-D system already implanted in patient scheduled to CRT-D system implantation according to current guidelines Exclusion Criteria: - Right Bundle Branch Block - Severe Irreversible Renal Failure (eGFR<30) - NYHA IV - Atrio-Ventricular Block above the 1st grade - Prosthetic Valves - Atrial Fibrillation at implantation |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Monaldi Hospital | Naples | |
| Italy | Università della Campania "Luigi Vanvitelli" | Naples |
| Lead Sponsor | Collaborator |
|---|---|
| Monaldi Hospital |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of CRT responder patients | A patient is considered "responder" if Left Ventricular End-Systolic Volume at 6 Months from CRT-D system implantation is reduced at least of 15% towards the baseline value | 6 Months |
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