QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead
This study is not yet open for participant recruitment.
Verified November 2012 by St. Jude Medical
Sponsor:
St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01733368
First received: October 2, 2012
Last updated: November 20, 2012
Last verified: November 2012
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Purpose
Optimization and evolution of the patient will be evaluated over 6 months after the implant.
| Condition |
|---|
|
Heart Failure |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Observational Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead |
Resource links provided by NLM:
Further study details as provided by St. Jude Medical:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 200 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Heart failure patients
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733368
Contacts
| Contact: Elena Llorente | +34917278940 | ellorente@sjm.com |
| Contact: Antonio Ruiz | +347278928 | aruiz@sjm.com |
Sponsors and Collaborators
St. Jude Medical
Investigators
| Principal Investigator: | Javier Alzueta, MD | Hospital Clínico Universitario Virgen de la Victoria |
More Information
No publications provided
| Responsible Party: | St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT01733368 History of Changes |
| Other Study ID Numbers: | CR-1 2-015-SP-HF |
| Study First Received: | October 2, 2012 |
| Last Updated: | November 20, 2012 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by St. Jude Medical:
|
CRT Optimization Responders |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013