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

NCT02493205 | Completed

• 1 other identifier: 201501RANA
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Implantable Cardiac Monitor; Stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cost-effectiveness for LINQ ICM holding area implants.

  90 days Post Implant

• Device functionality post-implant through patient trial exit visit.

  90 Days Post Implant

• Resource utilization for LINQ ICM holding area implants.

  90 Days Post Implant

• Procedures utilized during LINQ ICM holding area implants.

  90 Days Post Implant

• Techniques utilized during LINQ ICM holding area implants.

  90 Days Post Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patient is indicated for continuous arrhythmia monitoring with an Implantable Cardiac Monitor
• 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.
• Patient is 18 years of age or older.
• Patient is willing to provide informed consent and authorize disclosure of personal health information in accordance with state and national regulations.

You may not qualify if:

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

Sponsors & Collaborators

• Holy Cross Hospital, Florida: lead
• Medtronic: collaborator

Study Sites (1)

Jim Moran Heart and Vascular Research Institute

Fort Lauderdale, Florida, 33308, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 9, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 31, 2022

Record last verified: 2022-01

Locations

US (1)