Cardiac Resynchronization Therapy
Conditions
Brief summary
Pilot, perspective, multi-center non-randomized study comparing Multi-point pacing and conventional CRT through non-invasive hemodynamics measurement and Global Longitudinal Strain assessment
Interventions
DEVICECardiac Resynchronization Therapy device programming
Implanted CRT-D devices settings will be programmed based on the best acute hemodynamic response assessed non-invasively
Sponsors
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recent or scheduled implantation of CRT-D system with quadripolar lead and MPP technology in patient with indications to CRT according to current guidelines
Exclusion criteria
* Patients in Atrial Tachycardia (AT) or Atrial Fibrillation (AF) at the time of the enrollment or with persistent or long-standing persistent/chronic AF * NYHA IV patients * Right Bundle Branch Block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute improvement in cardiac function (1) | 24-48 hours after CRT-D implantation | change in dP/dtmax, expressed in mmHg/s, assessed through photoplethysmography. This assessment represents in a non-invasive fashion, the rise in pressure (P) developed inside left ventricle during contraction over time. |
| Acute improvement in cardiac function (2) | 24-48 hours after CRT-D implantation | change in global longitudinal strain, assessed through echocardiography. This assessment elucidates longitudinal shortening of the left ventricle as a percentage (change in length as a proportion to baseline length). GLS is derived from speckle tracking, and analyzed by post-processing of apical images of the left ventricle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delayed response (1) | 3 Months | change in GLS. Participants will investigate whether left ventricular remodeling upon patient-tailored biventricular stimulation will behave differentially according to type of stimulation; the total amount of CRT-responder patients will be therefore considered |
| Delayed response (2) | 3 Months | change in NYHA class. Participants will check if functional status will change after optimized biventricular stimulation therapy and will provide clinical data on CRT responders. |
Countries
Italy
Outcome results
None listed