N/A
N=178
Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00990665 ↗Enrolled (actual)
178
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Freedom From Left Ventricular Lead-Related Complications Through 3 Months — 96 percentage probability
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CRT-D and LV lead (Quartet™ lead and Promote Q® device system) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Left Ventricular Lead-Related Complications Through 3 Months |
96 | — |
| PRIMARY Freedom From System-related Complications Through 3 Months |
92 | — |
| PRIMARY The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months. |
79.2; 83.3 | — |
Summary
The objective of this study is to assess the safety and efficacy of the Quartet™ lead and Promote Q® device system in a patient population indicated for cardiac resynchronization therapy.
Eligibility Criteria
Inclusion Criteria
- Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or lifethreatening ventricular tachyarrhythmia(s)
- Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement.
- Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria
- Have had a recent CVA or TIA within three months of enrollment
- Have a contraindication for an emergency thoracotomy
- Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
- Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months
- Have undergone a cardiac transplantation within 40 days of enrollment
- Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA, Stent or CABG) within 40 days of enrollment
- Are currently participating in a clinical investigation that includes an active treatment arm
- Are pregnant or planning to become pregnant during the duration of the study
- Have a life expectancy of less than 6 months due to any condition
- Are less than 18 years of age
- Are unable to comply with the follow up schedule
Data sourced from ClinicalTrials.gov (NCT00990665). 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.