At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,078 enrolled
Drug / intervention
BiP Group +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges
In Brief
A clinical study evaluating BiP Group and Quad Group for Postoperative Cardiac Complication and 4 related conditions. Completed, enrolled 1,078 participants across 64 sites in 13 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Cardiac Complication, Heart Failure, Left Ventricular Cardiac Dysfunction, Inappropriate Phrenic Nerve Stimulation, Perioperative/Postoperative Complications
CountriesBelgium, Canada, Finland, France, Germany, India, Israel, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
First PostedJan 2012
Primary CompletionMay 2014
TodayJul 2026
First PostedJan 16, 2012
Enrollment StartNov 1, 2011
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.5 years ago
Interventions
BiP Groupprocedure
Implantation of standard Left Ventricular (LV) lead
Quad Groupdevice
Implantation of quadripolar Left ventricular (LV) lead Quartet