NCT02493205

The Holding Area LINQ (Reveal LINQ Insertable Cardiac Monitor) Trial is a Prospective, Non-randomized, Single Center Post-market Clinical Trial

The Holding Area LINQ Trial is a Prospective, Non-randomized, Single Center Post-market Clinical Trial Designed to Occur in the Holding Area of a Hospital Operating Room or Cardiac Catheterization/Electrophysiology Laboratory

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Holy Cross Hospital, Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Holding Area LINQ Trial is a clinical trial designed to compare the benefits in conducting impant procedures in the holding area of a hospital operating room vs cardiac catheterization/electrophysiology laboratory.

Detailed description

The Holding Area LINQ Trial is a prospective, non-randomized, single center post-market clinical trial designed to occur in the holding area of a hospital operating room or cardiac catheterization/electrophysiology laboratory. The primary objective is to characterize the rate of procedure-related complications within 90 days of the implant procedure which require resolution by surgical intervention. Twenty (20) patients with established clinical indications for the LINQ ICM (Reveal LINQ Insertable Cardiac Monitor) will be implanted using standard of care techniques and procedures. Implants will be required to take place in a hospital holding area rather than the traditional facility locations such as the hospital operating room, cardiac catheterization lab, or electrophysiology lab. A physical description of the holding area is a small patient examination room separated from other patient exam bay by walls and a door. There is a sink in the patient exam room, laminate flooring, ceiling A/C vent, wall mounted Hemodynamic monitoring equipment, and wall mounted oxygen/suction lines. Patient sedation will be limited to local anesthetics and/or oral anti-anxiety medications. Intravenous access will be obtained only for emergency resuscitative measures. Due to the low complication rate for this type of implant and practical limitations on the sample size, there are no formal hypotheses tested in this trial. This study will characterize all procedure-related adverse events that occur within 90 days of the implant procedure. Data will be collected at implant, 7-10 day post-op visit, and 90-day post-implant visits.

Conditions

• Coronary Artery Disease

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-06-01
• Completion: 2016-11-01
• First posted: 2015-07-09
• Last updated: 2022-01-31

Locations

1 site across 1 country: United States