N/A
Completed N=198
QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead
Source: ClinicalTrials.gov NCT01733368 ↗Enrolled (actual)
198
Serious AEs
25.3%
Results posted
Mar 2018
Primary outcomePrimary: Number of Responder Patients (Structural Remodelling) — 94 Participants
Summary
Optimization and evolution of the patient will be evaluated over 6 months after the implant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Responder Patients (Structural Remodelling) |
94 | — |
| PRIMARY Safety Outcomes in CRT Responders and Non-Responders |
0; 6; 17; 16; 17; 20 | — |
| SECONDARY Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector |
38 | — |
| SECONDARY Number of Responder Patients With Conventional Left Ventricular Pacing Vector |
56 | — |
Eligibility Criteria
Inclusion Criteria
- Patient with implanted CRT-D device and a QuartetTM quadripolar lead by St. Jude Medical in the left ventricle.
- Patient with an echocardiographic study performed during 1 month prior to the implant and in whom End Systolic Volume of the Left Ventricle (LVESV) has been measured
- Patients who have granted their informed consent.
- Patients above 18 years.
Exclusion Criteria
- Patients that have been previously resynchronized.
- Patients with aortic stenosis or aortic valve prosthesis
- Patients who are or may potentially be pregnant.
- Patients with a life expectancy <12 months.
- Patients who cannot attend the monitoring visits established by the protocol.
Data sourced from ClinicalTrials.gov (NCT01733368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.