N/A
N=749
Quadripolar CRT-D On Currently Approved Lead SystemS
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02232984 ↗Enrolled (actual)
749
Serious AEs
2.1%
Results posted
Feb 2019
Primary outcome: Primary: Number of Vectors With Phrenic Nerve Stimulation (PNS) — 181; 189 Number of Pacing vectors with PNS
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Vectors With Phrenic Nerve Stimulation (PNS) |
181; 189 | — |
| SECONDARY Final Pacing Treshold at Pre-discharge |
1.93 | — |
| SECONDARY Final LV Lead Impedance at Pre-discharge |
1034.7 | — |
| SECONDARY Final Sensing Amplitude at Pre-discharge |
13.30 | — |
| SECONDARY Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems |
82.4; 87.8; 24.5; 29.8; 6.2; 7.8 | — |
Summary
The purpose of the study is to evaluate different ways to program around extracardiac stimulation.
Eligibility Criteria
Inclusion Criteria
- Subject is medically indicated for implantation with a Boston Scientific (BSC) DYNAGEN or INOGEN X4 CRT-D (or any future FDA approved BSC X4 CRT-D) and already implanted with/scheduled to receive a commercially available quadripolar left ventricular lead
- Subject is willing and capable of providing informed consent and participating in all testing and study visits associated with this investigation at an approved center and at the intervals defined by this protocol
- Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion Criteria
- Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
- Subject is enrolled in any other concurrent study, without prior approval from BSC
- Women of childbearing potential who are or might be pregnant at the time of study enrollment
Data sourced from ClinicalTrials.gov (NCT02232984). 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.