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

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 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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Jim Moran Heart and Vascular Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients 18 and older indicated for continuous arrhythmia monitoring with an Implantable Cardiac Monitor

Description

Inclusion Criteria:

1. Patient is indicated for continuous arrhythmia monitoring with an Implantable Cardiac Monitor
2. Patient is willing to undergo implant in holding area setting with only local anesthetic and/or oral anti-anxiety medications for sedation (2 mg of Valium or Ativan) at patient request.
3. Patient is 18 years of age or older.
4. Patient is willing to provide informed consent and authorize disclosure of personal health information in accordance with state and national regulations.

Exclusion Criteria:

1. Patient has reduced immune function or is otherwise at high risk for infection
2. Patient has had a recent (within 30 days) or otherwise unresolved infection.
3. Patient is implanted or indicated for implant with a pacemaker, Implantable Cardiac Device (ICD), Cardiac Resyncronization Therapy (CRT) or hemodynamic monitoring system.
4. Patient is participating in another clinical trial that may have an impact on the trial endpoints.
5. Patient has a super-therapeutic INR > 3.0.
6. Patient considered by Principal Investigator and/or sub-investigator to be inappropriate for the trial for any reason.
7. Patient's life expectancy is less than 1 year.
8. Patient is pregnant.
9. Patient has an unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure.
10. Inability to comply with planned trial procedures

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of procedure-related complications within 90 days of implant which require resolution by surgical intervention.	-For this study there is no formal hypothesis or performance criterion tested for this objective. Instead, the rate of these complications will be characterized by computing a point estimate and one-sided upper 95% confidence interval for the rate of procedure-related complications requiring surgical intervention 90 days post-implant-	90 days post-implant.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness for LINQ ICM holding area implants.	Procedure duration as well as the types of personnel and resources needed for LINQ implant will be collected on the implant case report form. This information will be summarized using summary statistics and/or graphical methods.	90 days Post Implant
Device functionality post-implant through patient trial exit visit.	Device functionality post-implant will be characterized by collecting R-wave amplitudes on the day of implant and at the 90-day follow-up visit. Following each implant, R-wave amplitude will be collected and recorded on the Implant e-CRF. In addition, R-wave amplitude will be collected and recorded at the 90-day follow-up visit or at an unscheduled visit should the patient exit the study prior to the 90-day follow-up visit. Summary statistics and/or graphical methods will be used to summarize the R-wave amplitude.	90 Days Post Implant
Resource utilization for LINQ ICM holding area implants.	Procedure duration as well as the types of personnel and resources needed for LINQ implant will be collected on the implant case report form. This information will be summarized using summary statistics and/or graphical methods.	90 Days Post Implant
Procedures utilized during LINQ ICM holding area implants.	Procedure duration as well as the types of personnel and resources needed for LINQ implant will be collected on the implant case report form. This information will be summarized using summary statistics and/or graphical methods.	90 Days Post Implant
Techniques utilized during LINQ ICM holding area implants.	Procedure duration as well as the types of personnel and resources needed for LINQ implant will be collected on the implant case report form. This information will be summarized using summary statistics and/or graphical methods.	90 Days Post Implant

Collaborators and Investigators

• Sponsor: Holy Cross Hospital, Florida
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: June 30, 2015
• First Submitted That Met QC Criteria: July 8, 2015
• First Posted (Estimate): July 9, 2015

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Stent; Implantable Cardiac Monitor
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 201501RANA