Heart FailureQUARTO-IINCT01733368
QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead
An observational study of Heart Failure, run by Abbott Medical Devices at 1 site in Spain.
Trial summary
Optimization and evolution of the patient will be evaluated over 6 months after the implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 198 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2012to Aug 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart failure patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational 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.
Read the detailed description
Patient will be enrolled into the study after Informed Consent signature and CRT-D+quadripolar (QuartetTM) LV lead.
- Conditions
- Heart Failure
- Keywords
- CRT, Optimization, Responders
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 6 months after implant
Secondary outcomes (2)
Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector
Response is defined as a reduction >15% in LVESV, measured 6 months after implant.
Non-conventional pacing vectors are the pacing vectors exclusive to the Quartet LV quadripolar lead, not available in the conventional bipolar leads.
Measured: 6 months after implant
Number of Responder Patients With Conventional Left Ventricular Pacing Vector
Response is defined as a reduction >15% in LVESV, measured 6 months after implant.
Conventional pacing vectors are the pacing vectors available both in the Quartet LV quadripolar lead and in the conventional bipolar leads.
Measured: 6 months after implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Javier Alzueta, MD, Principal investigator, Hospital Clínico Universitario Virgen de la Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733368
- Sponsor's protocol ID
- CR-1 2-015-SP-HF
- Acronym
- QUARTO-II
- Status last verified
- Jan 2019
- First submitted
- 2 Oct 2012
- Last updated
- 4 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No plan
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead
- ClinicalTrials.gov ID
- NCT01733368
- Acronym / sponsor ID
- QUARTO-II / CR-1 2-015-SP-HF
- Conditions
- Heart Failure
- Keywords
- CRT, Optimization, Responders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Posted 1 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Optimization and evolution of the patient will be evaluated over 6 months after the implant.
Detailed description
Patient will be enrolled into the study after Informed Consent signature and CRT-D+quadripolar (QuartetTM) LV lead.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Responder Patients (Structural Remodelling)
Time frame: 6 months after implant
Structural remodelling is defined as a reduction >15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant.
Safety Outcomes in CRT Responders and Non-Responders
Time frame: 6 months after implant
* Mortality rate, * Rate of cardiovascular hospitalizations and for any cause or * Combined endpoint (death and all-cause hospitalization)
2 secondary outcomes
Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector
Time frame: 6 months after implant
Number of Responder Patients With Conventional Left Ventricular Pacing Vector
Time frame: 6 months after implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Alzueta, MD principal investigator
Hospital Clínico Universitario Virgen de la Victoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Abbott Medical Devices at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Responder Patients (Structural Remodelling) (time frame: 6 months after implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.