N/A
N=1,074
More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges
Postoperative Cardiac Complication · Heart Failure · Left Ventricular Cardiac Dysfunction · Inappropriate Phrenic Nerve Stimulation · Perioperative/Postoperative Complications
Bottom Line
View on ClinicalTrials.gov: NCT01510652 ↗Enrolled (actual)
1,074
Serious AEs
50.6%
Results posted
Oct 2015
Primary outcome: Primary: Lead Performance — 83; 74.4 % of patients with freedom from event
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BiP Group (Procedure); Quad Group (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lead Performance |
83; 74.4 | — |
| SECONDARY Percentage of Cardiac Resynchronization Therapy Responders |
62.0; 56.0 | — |
| SECONDARY Implant Duration |
100.4; 101.1 | — |
Summary
This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads.
Eligibility Criteria
Inclusion Criteria
- Patients are indicated for Cardiac Resynchronization Therapy with Defibrillation backup device (CRT-D) implantation, as per current international certified guidelines
- Patients age is 18 years or greater
- Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form
- Patients must be willing and able to comply with all study requirements
Exclusion Criteria
- Patients with a life expectancy <12 months.
- Patients who are or may potentially be pregnant.
- Patient has suffered any of the following in the 4 weeks prior to enrolment:
- Myocardial Infarction (MI)
- Coronary Artery Bypass Graft (CABG)
- Unstable Angina Pectoris
- Patient has primary valvular disease which has not been corrected
Data sourced from ClinicalTrials.gov (NCT01510652). 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.