Trials / Completed
CompletedNCT01510652
More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges
More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,078 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Postoperative Cardiac Complication
- Heart Failure
- Left Ventricular Cardiac Dysfunction
- Inappropriate Phrenic Nerve Stimulation
- Perioperative/Postoperative Complications
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | BiP Group | Implantation of standard Left Ventricular (LV) lead |
| DEVICE | Quad Group | Implantation of quadripolar Left ventricular (LV) lead Quartet |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2014-05-01
- Completion
- 2014-05-01
- First posted
- 2012-01-16
- Last updated
- 2019-02-15
- Results posted
- 2015-10-23
Locations
64 sites across 13 countries: Belgium, Canada, Finland, France, Germany, India, Israel, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01510652. Inclusion in this directory is not an endorsement.