QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead
QUARTO-II
Observational Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead
1 other identifier
observational
198
1 country
1
Brief Summary
Optimization and evolution of the patient will be evaluated over 6 months after the implant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedFirst Posted
Study publicly available on registry
November 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
March 1, 2018
CompletedFebruary 4, 2019
January 1, 2019
2.7 years
October 2, 2012
May 31, 2017
January 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Responder Patients (Structural Remodelling)
Structural remodelling is defined as a reduction \>15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant.
6 months after implant
Safety Outcomes in CRT Responders and Non-Responders
* Mortality rate, * Rate of cardiovascular hospitalizations and for any cause or * Combined endpoint (death and all-cause hospitalization)
6 months after implant
Secondary Outcomes (2)
Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector
6 months after implant
Number of Responder Patients With Conventional Left Ventricular Pacing Vector
6 months after implant
Eligibility Criteria
Heart failure patients
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario Virgen de la Victoria
Málaga, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Javier Alzueta Rodríguez
- Organization
- Hospital Clinico Universitario Virgen de la Victoria
Study Officials
- PRINCIPAL INVESTIGATOR
Javier Alzueta, MD
Hospital Clínico Universitario Virgen de la Victoria
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2012
First Posted
November 27, 2012
Study Start
November 1, 2012
Primary Completion
August 1, 2015
Study Completion
August 1, 2016
Last Updated
February 4, 2019
Results First Posted
March 1, 2018
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share
No plan