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

Coronary Artery Disease Clinical Trial

— HALT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02493205
• Other study ID #: 201501RANA
• Status: Completed
• Start date: June 2015
• Est. completion date: November 2016

Study information

• Verified date: January 2022
• Source: Holy Cross Hospital, Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
United States	Jim Moran Heart and Vascular Research Institute	Fort Lauderdale	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Holy Cross Hospital, Florida	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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