QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead
Optimization and evolution of the patient will be evaluated over 6 months after the implant.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Observational Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead|
- Optimization method [ Time Frame: From implant procedure until 6 months post-implant ] [ Designated as safety issue: No ]
Optimization method. The primary endpoint of this study is to evaluate the usual management (according to the different methods of optimisation used) of patients undergoing Cardiac Resynchronization Therapy (CRT), that have a QuartetTM quadripolar lead with a CRT-D Device implanted during the 6 months post-implant.
Information about the optimization method used, parameters and variables used with them and number of optimization during 6months post-implant will be collected.
- Safety [ Time Frame: From implant procedure until 6 months post-implant ] [ Designated as safety issue: Yes ]Number of patients with device-related adverse events as a measure of safety, deaths, cardiovascular hospitalizations and hospitalisations for any reason, assessed up to 6 months post-implant.
- Percentage of responder patients (structural remodelling) [ Time Frame: 6 Months after implant ] [ Designated as safety issue: No ]Structural remodelling is defined as a reduction >15% in End Systolic Volume of the Left Ventricle (LVESV), measured 6months after implant.
- Demographic data [ Time Frame: Up to 10 days post-implant ] [ Designated as safety issue: No ]Collect demographic information (gender, age, height, weight), medical and cardiovascular history.
- Treated TV/FV episodes incidence [ Time Frame: From implant procedure until 6 months post-implant ] [ Designated as safety issue: No ]Number of treated TV/FV episodes over the 6 months post-implant
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Patient will be enrolled into the study after Informed Consent signature and CRT-D+quadripolar (QuartetTM) LV lead.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733368
|Contact: Elena Llorenteemail@example.com|
|Contact: Antonio Ruizfirstname.lastname@example.org|
|Principal Investigator:||Javier Alzueta, MD||Hospital Clínico Universitario Virgen de la Victoria|