Coronary Artery DiseaseHALTNCT02493205
The Holding Area LINQ (Reveal LINQ Insertable Cardiac Monitor) Trial is a Prospective, Non-randomized, Single Center Post-market Clinical Trial
An observational study of Coronary Artery Disease, run by Holy Cross Hospital, Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 and older indicated for continuous arrhythmia monitoring with an Implantable Cardiac Monitor
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jim Moran Heart and Vascular Research Institute
Fort Lauderdale, Florida, 33308
About this study
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
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.
Read the 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
- Keywords
- Implantable Cardiac Monitor, Stent
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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-
Measured: 90 days post-implant.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90 Days Post Implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holy Cross Hospital, Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Wilson Burke, Holy Cross Hospital, Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493205
- Sponsor's protocol ID
- 201501RANA
- Acronym
- HALT
- Status last verified
- Jan 2022
- First submitted
- 30 Jun 2015
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02493205
- Acronym / sponsor ID
- HALT / 201501RANA
- Conditions
- Coronary Artery Disease
- Keywords
- Implantable Cardiac Monitor, Stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Holy Cross Hospital, FloridaUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 and older indicated for continuous arrhythmia monitoring with an Implantable Cardiac Monitor
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of procedure-related complications within 90 days of implant which require resolution by surgical intervention.
Time frame: 90 days post-implant.
-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-
5 secondary outcomes
Cost-effectiveness for LINQ ICM holding area implants.
Time frame: 90 days Post Implant
Device functionality post-implant through patient trial exit visit.
Time frame: 90 Days Post Implant
Resource utilization for LINQ ICM holding area implants.
Time frame: 90 Days Post Implant
Procedures utilized during LINQ ICM holding area implants.
Time frame: 90 Days Post Implant
Techniques utilized during LINQ ICM holding area implants.
Time frame: 90 Days Post Implant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Holy Cross Hospital, Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of procedure-related complications within 90 days of implant which require resolution by surgical intervention. (time frame: 90 days post-implant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.