N/A
N=105
Quartet Lead and Resynchronization Therapy Options III (QUARTO_III)
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02476201 ↗Enrolled (actual)
105
Serious AEs
15.2%
Results posted
Aug 2020
Primary outcome: Primary: Number of CRT Responders — 53 Participants — p=0.0435
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MPP ON (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of CRT Responders |
53 | 0.0435 sig |
| SECONDARY Changes in LV Echocardiographic Parameters |
-25.33; -14.90; -10.72; -7.23; 9.37 | — |
| SECONDARY Number of CRT Super-responders |
27 | — |
| SECONDARY Rates of Hospitalization and Mortality |
2; 12; 1; 4; 2; 6 | — |
| SECONDARY Change in NYHA Classification |
26; 2; 54 | — |
Summary
The purpose of the study is to assess prospectively at 6 months the percentage of responder patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.
Eligibility Criteria
Inclusion Criteria
- Patient that will be implanted with a Cardiac Resynchronization Therapy (CRT-D) with the MultiPoint Pacing (MPP) feature under the current Guidelines indications for CRT-D implant (including upgrades from single or dual chamber Defibrillator or Pacemaker).
- Patient that will be implanted with a Quartet Left Ventricular (LV) quadripolar lead.
- In sinus rhythm at baseline visit.
- Patients with Left Bundle Branch Block (LBBB)
- Must be willing and able to comply with study requirements.
- Older than 18 years
- Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form.
Exclusion Criteria
- Already has a CRT device implanted.
- Myocardial Infarction or unstable angina within 40 days prior the enrollment.
- New York Heart Association (NYHA) Class IV
- Recent cardiac revascularization in the 4 weeks prior to enrollment.
- Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment.
- Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months.
- Primary valvular disease requiring surgical intervention.
- Atrial Fibrillation (AF):
- Persistent AF at the time of enrollment or 30 days prior the enrollment
- Permanent AF not treated with Atrio-Ventricular node ablation within 2 weeks after the CRT-D implant
- History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment
- Patient for whom suitable Transthoracic echocardiographic images for determining the cardiac output (CO) and LV volumes cannot be obtained.
- Undergone a cardiac transplantation or being waiting for it
- Life expectancy < 6 months
- Pregnancy or planning to become pregnant
- Unable to comply with the follow up schedule
- Currently participating in any other clinical investigation.-
Data sourced from ClinicalTrials.gov (NCT02476201). 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.