Heart FailureAPVSNCT02943941
Pressure Variability Study
A study testing Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body. in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in United States.
Trial summary
The purpose of this study is to understand how the pressure in the pulmonary artery changes under different conditions of posture, respiration and exertion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Investigator believes the patient's condition is sufficiently stable to safely participate in the study procedures
- Subject is currently implanted with a commercially available pulmonary artery pressure sensor and device communication has been reliable (recent history of successful communications with patient communication system)
Who cannot join
- Subject has a history of primary PAH
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Lindner Research Center
Cincinnati, Ohio, 45219
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Aquarius Pressure Variability Study
The purpose of this study is to understand how the pressure in the pulmonary artery changes under different conditions of posture, respiration and exertion.
Read the detailed description
This is a prospective, multi-center, observational study with enrollment up to 30 subjects at 2 U.S. sites. All study data can be collected on a single day as a one-time visit (lasting approximately 90-120 minutes).
This study is a Non-Significant Risk (NSR) Investigational Device Exemption (IDE) study as LINQ™ HF investigational RAMware is required to activate additional sensors in the Reveal LINQ ICM.
The patient will come to the clinic for a single in-office visit. PA pressure will be measured while the patient is in a variety of positions and during different respiratory exercises and after brief exertion. Data will be collected on eCRFs.
The effects of the different postures, respiration and exertion will be quantified using descriptive statistics (mean, standard deviation).
- Conditions
- Heart Failure
- Being tested
- Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.Other
Also called Interventions included: Changing posture, changing respiration, and changing exertion
Cardiac Monitor with LINQ™ HF Investigational RAMware download
| Study group | Role | What they receive |
|---|---|---|
| All participants | Other | All participants enrolled in a single arm to evaluate effect of variables (posture, respiration, exertion) on pulmonary artery pressure (PAP) Receives: Other: Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture
Posture defined as lying left side down compared to baseline supine
Measured: Same day as enrollment (during office visit, maximum of 30 minutes after baseline masurement)
Secondary outcomes (2)
Change in PAP During Change in Respiration
Outcome measure defined as PAP during coughing compared to PAP during normal breathing respiration at baseline.
Measured: Same day as enrollment (during office visit, maximum of 30 minutes after baseline measurement)
Change in PAP as Measured After Mild Exertion Compared to Initial Baseline PAP at Rest.
Measured: Same day as enrollment (during office visit, maximum of 10 minutes after baseline measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Verla Laager, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943941
- Sponsor's protocol ID
- Pressure
- Acronym
- APVS
- Status last verified
- Apr 2019
- First submitted
- 8 Aug 2016
- Last updated
- 12 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aquarius Pressure Variability Study
- ClinicalTrials.gov ID
- NCT02943941
- Acronym / sponsor ID
- APVS / Pressure
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 25 Oct 2016 (estimated)
- Results
- Posted 12 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand how the pressure in the pulmonary artery changes under different conditions of posture, respiration and exertion.
Detailed description
This is a prospective, multi-center, observational study with enrollment up to 30 subjects at 2 U.S. sites. All study data can be collected on a single day as a one-time visit (lasting approximately 90-120 minutes).
This study is a Non-Significant Risk (NSR) Investigational Device Exemption (IDE) study as LINQ™ HF investigational RAMware is required to activate additional sensors in the Reveal LINQ ICM.
The patient will come to the clinic for a single in-office visit. PA pressure will be measured while the patient is in a variety of positions and during different respiratory exercises and after brief exertion. Data will be collected on eCRFs.
The effects of the different postures, respiration and exertion will be quantified using descriptive statistics (mean, standard deviation).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Other | Other: Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.All participants enrolled in a single arm to evaluate effect of variables (posture, respiration, exertion) on pulmonary artery pressure (PAP) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Investigator believes the patient's condition is sufficiently stable to safely participate in the study procedures
- Subject is currently implanted with a commercially available pulmonary artery pressure sensor and device communication has been reliable (recent history of successful communications with patient communication system)
Key exclusion criteria (1 listed)
- Subject has a history of primary PAH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.Also: Interventions included: Changing posture, changing respiration, and changing exertionCardiac Monitor with LINQ™ HF Investigational RAMware download | Other | All participants |
Primary outcome
Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture
Time frame: Same day as enrollment (during office visit, maximum of 30 minutes after baseline masurement)
Posture defined as lying left side down compared to baseline supine
2 secondary outcomes
Change in PAP During Change in Respiration
Time frame: Same day as enrollment (during office visit, maximum of 30 minutes after baseline measurement)
Change in PAP as Measured After Mild Exertion Compared to Initial Baseline PAP at Rest.
Time frame: Same day as enrollment (during office visit, maximum of 10 minutes after baseline measurement)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Verla Laager study director
Medtronic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body. in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites 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 2 inclusion and 1 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 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 12 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture (time frame: Same day as enrollment (during office visit, maximum of 30 minutes after baseline masurement)). 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 12 Apr 2019.