Phase 4
N=51
Quartet Lead and Resynchronization Therapy Options
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01295840 ↗Enrolled (actual)
51
Serious AEs
23.5%
Results posted
Mar 2015
Primary outcome: Primary: Number of Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet® Left Ventricular Electrode. — 27 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cardiac Resynchronization Therapy Defibrillator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet® Left Ventricular Electrode. |
27 | — |
| SECONDARY Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors |
11.69 | — |
| SECONDARY Cardiac Output (CO) With Different Configurations at Enrollment |
3.64; 4.16; 4.33 | — |
| SECONDARY Capture Threshold |
0.96; 1.21; 0.90 | — |
| SECONDARY Capture Threshold |
0.96; 1.21; 0.90 | — |
| SECONDARY Number of Vectors With Phrenic Nerve Stimulation (PNS) |
49; 69; 118 | — |
| SECONDARY Number of Vectors With Phrenic Nerve Stimulation (PNS) |
49; 69; 118 | — |
| SECONDARY Number of Patients With PNS in All Vectors |
7 | — |
| SECONDARY Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector |
5 | — |
| SECONDARY Number of Patients With PNS in All Vectors |
7 | — |
| SECONDARY Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector |
5 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients with a Cardiac resynchronization Therapy Defibrillator device (CRT-D) and a Quartet® quadripolar electrode from St Jude Medical (used in "Single Site Pacing" mode) implanted in the left ventricle.
- 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 echocardiographic study of the enrollment visit.
- Patients with valvular disease.
- Patients in functional class New York Heart Association (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
Data sourced from ClinicalTrials.gov (NCT01295840). 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.