Quartet Lead and Resynchronization Therapy Options (QUARTO)
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Purpose
The purpose of this Clinical Trial is to determine the percentage of patients whose hemodynamic response improves with the different configurations offered by the new Quartet® left ventricular lead, as a result of its four electrodes, with respect to the configurations offered by a standard bipolar lead.
Furthermore, the optimal stimulation configuration will be determined from a comparison with traditional configurations.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Device: Cardiac Resynchronization Therapy Defibrillator |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | QUARTET LEAD AND RESYNCHRONIZATION THERAPY OPTIONS To Investigate the Stimulatory Possibilities Offered by the Different Configurations Available for the Quartet Lead and Their Effect on Haemodynamic and Clinical Response. |
- The percentage of patients whose cardiac output value in acute, as measured echocardiographically, improves with the different stimulation vectors offered by the Quartet® left ventricular electrode. [ Time Frame: The trial involves a single data-collection visit, which will be undertaken in the seven days after implantation of the device. ] [ Designated as safety issue: No ]The clinical response will be assessed on the basis of the change in each patient's cardiac output using the different stimulation configurations offered by the Quartet® electrode in comparison with conventional stimulation with a bipolar left ventricular electrode (with the reference configurations LV Point-LV Loop, LV Point-RD Coil, LV Loop-RD Coil) as well as the baseline values, in other words without stimulation.
- Width of the QRS. [ Time Frame: The trial involves a single data-collection visit, which will be undertaken in the seven days after implantation of the device. ] [ Designated as safety issue: No ]The width of the QRS complex will be measured and its correlation with each patient's cardiac output will be determined for each of the different stimulation configurations used.
- Presence of mitral regurgitation. [ Time Frame: The trial involves a single data-collection visit, which will be undertaken in the seven days after implantation of the device. ] [ Designated as safety issue: No ]The presence of mitral regurgitation will be assessed echocardiographically for each of the configurations used.
- The optimization AV and VV delay values. [ Time Frame: The trial involves a single data-collection visit, which will be undertaken in the seven days after implantation of the device. ] [ Designated as safety issue: No ]
The optimization AV and VV delay values used for each of the configurations studied will be noted.
Attempts will be made to determine the optimal stimulation configuration for each patient's hemodynamics using the measurements undertaken.
- Capture and phrenic threshold. [ Time Frame: The trial involves a single data-collection visit, which will be undertaken in the seven days after implantation of the device. ] [ Designated as safety issue: No ]
Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.
Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.
- The final position of the electrode. [ Time Frame: The trial involves a single data-collection visit, which will be undertaken in the seven days after implantation of the device. ] [ Designated as safety issue: No ]Information regarding the final position of the electrode and its relationship with the other parameters evaluated, namely electrical measurements of the capture and phrenic thresholds, QRS width and cardiac output and mitral regurgitation values, will also be collected.
- Final stimulation vector programmed. [ Time Frame: The trial involves a single data-collection visit, which will be undertaken in the seven days after implantation of the device ] [ Designated as safety issue: No ]Information regarding the final stimulation vector program selected by the physician for patients with a Quartet® lead implanted in the left ventricle will also be collected.
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: CRT therapy
Cardiac Resynchronization Therapy Defibrillator (CRT-D)
|
Device: Cardiac Resynchronization Therapy Defibrillator
Cardiac Resynchronization Therapy Defibrillator
Other Names:
|
Detailed Description:
This is a prospective, non-randomised, multi-centre, national, interventional clinical trial of a medical device.
This trial involves a single visit, which will be undertaken in the seven days following implantation. Resynchronization therapy in those patients suitable for participation in this trial is expected to begin once the trial visit has been completed.
The trial involves a single data-collection visit, which will be undertaken in the seven days after implantation of the device. It is recommended that this visit be undertaken as soon as possible after implantation, although the time window allows the timing to be adapted to each centre's standard practice. Resynchronization therapy in those patients suitable for participation in this trial is expected to begin once this visit has been completed.
Once the trial and data collection have been completed, final device programming will be based on each investigator's criteria and will be undertaken following the standard practice of each centre.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with a CRT-D and a Quartet® quadripolar electrode from St Jude Medical (used in "Single Site Pacing" mode) implanted in the left ventricle.
- Non-ischemic patients.
- Patients who have provided written informed consent
- Patients who are in sinus rhythm.
- Patients older than 18 years of age.
Exclusion Criteria:
- Patients in atrial fibrillation at the time of the trial.
- Patients with valvular disease.
- Ischemic patients.
- Patients in functional class NYHA IV
- Patients for whom echocardiography images suitable for determining the cardiac output cannot be obtained.
- Patients whose device has been changed/upgraded.
- Pregnant patients.
- Patients who do not fulfill all the inclusion criteria.
- Patients who are unable to provide written informed consent
Contacts and Locations| Spain | |
| Hospital Clínico Universitario Virgen de la Victoria | |
| Málaga, Spain, 29010 | |
| Principal Investigator: | Dr. Francisco Javier Alzueta Rodríguez, PhD | Hospital Clínico Universitario Virgen de la Victoria |
More Information
No publications provided
| Responsible Party: | St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT01295840 History of Changes |
| Other Study ID Numbers: | CR 10-046-SP-HF |
| Study First Received: | February 3, 2011 |
| Last Updated: | November 28, 2011 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013