Heart FailureINTELLECT 2-HFNCT03247829
Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™
An observational study of Heart Failure, run by Abbott Medical Devices at 23 sites in United States.
Trial summary
This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional status, quality of life, and readmissions Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Hemodynamic management using CardioMEMS HF System
- Type of treatment
- Medical device
- How many people
- 101 participants
- Where
- 23 sitesUnited States
- Study dates
- 24 Aug 2017to 30 Jun 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart Failure patients will be recruited from the clinicians practice based on the presence of both devices under study
Who may be able to join
- Subject has CardioMEMS HF PA Sensor and a commercially-approved HeartMate LVAD (Group A) OR Subject has commercially-approved HeartMate LVAD, is experiencing NYHA class III symptoms, and has had a previous HF hospitalization and meets FDA indications for CardioMEMS. The CardioMEMS PA Sensor must be implanted within 72 hours of consent (Group B)
- Signed an informed consent form and agreed to provide access to patient and device data (including CardioMEMS Merlin.net data)
- No connectivity or transmission problems with CardioMEMS
- On HeartMate LVAD support for at least 3 months
- Age ≥ 18 years
Who cannot join
- Current participation in an investigation that is likely to confound study results or affect study outcome
- Current participation in the MOMENTUM3 IDE Clinical trial and has not completed the two year follow-up for that trial
- Inability to perform 6MHW test due to conditions other than heart failure (e.g. severe arthritis, orthopedic issues, amputation etc.)
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27607
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Palmetto Health Richland
Columbia, South Carolina, 29203
Ohio Sate University
Columbus, Ohio, 43210
The Methodist Hospital
Houston, Texas, 77030
Scripps Health
La Jolla, California, 92037
University of Kentucky
Lexington, Kentucky, 40536
USC University Hospital
Los Angeles, California, 90033
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
North Shore University Hospital
Manhasset, New York, 11030
Aurora Medical Center
Milwaukee, Wisconsin, 53215
University of Minnesota
Minneapolis, Minnesota, 55455
New York-Presbyterian/Columbia University Medical Center
New York, New York, 10032
The Nebraska Medical Center
Omaha, Nebraska, 68105
Providence Heart and Vascular Institute
Portland, Oregon, 97225
University of North Carolina
Raleigh, North Carolina, 27607
University of Rochester Medical Center
Rochester, New York, 14642
St. Francis Hospital
Roslyn, New York, 11576
University of Utah Hospital
Salt Lake City, Utah, 84132
San Diego Cardiac
San Diego, California, 92123
California Pacific Medical Center - Van Ness Campus
San Francisco, California, 94109
About this study
Official title: Investigation to Optimize Hemodynamic Management of HeartMate II™ Left Ventricular Assist Device Patients Using the CardioMEMS™ Pulmonary Artery Pressure Sensor in Advanced Heart Failure
This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional status, quality of life, and readmissions
Read the detailed description
The study is an observational, single group study where all participants receive the same intervention. The study plans to enroll up to 100 patients at 25 US sites. All patients will have a HeartMate Left Ventricular Assist Device (LVAD) and a CardioMEMS device implanted as standard of care. After enrollment into the study, the patient will be followed until six month follow up completion. The objective of this clinical investigation is to understand the role of hemodynamic monitoring in LVAD patients and:
- Characterize PA pressure measurements with the CardioMEMS HF System in LVAD patients under different clinical and physiologic conditions
- Characterize the effects of PA pressure on functional status, quality of life, and hospital readmissions of LVAD patients
- Evaluate target ranges for PA pressure and assess the impact of medication and pump speed changes on PA pressures
- Conditions
- Heart Failure
- Being tested
- Hemodynamic management using CardioMEMS HF System
- Keywords
- CardioMEMS, Left Ventricular Assist Device, Hemodynamic Management
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamic management using CardioMEMS HF SystemDevice
Using the CardioMEMS HF System, clinicians will treat to target PA pressure ranges
| Study group | Role | What they receive |
|---|---|---|
| Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment | Patients with CardioMEMS PA Sensor and LVAD, previously implanted, will receive hemodynamic management using CardioMEMS HF System Receives: Device: Hemodynamic management using CardioMEMS HF System | |
| Group B: Patients with existing HeartMate LVAD implanted with CardioMEMS PA Sensor post enrollment | Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, will receive hemodynamic management using CardioMEMS HF System Receives: Device: Hemodynamic management using CardioMEMS HF System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six Minute Hall Walk (6MHW) Distance
Change in 6MHW distance compared to baseline. The six-minute hall walk (6MHW) test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start24 Aug 2017
- Primary completion6 Mar 2020
- Study completion30 Jun 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kartik Sundareswaran, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247829
- Sponsor's protocol ID
- SJM-CIP-10178
- Acronym
- INTELLECT 2-HF
- Status last verified
- Jan 2021
- First submitted
- 4 Aug 2017
- Last updated
- 26 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thohan V, Abraham J, Burdorf A, Sulemanjee N, Jaski B, Guglin M, Pagani FD, Vidula H, Majure DT, Napier R, Heywood TJ, Cogswell R, Dirckx N, Farrar DJ, Drakos SG; INTELLECT 2-HF Investigators. Use of a Pulmonary Artery Pressure Sensor to Manage Patients With Left Ventricular Assist Devices. Circ Heart Fail. 2023 Jun;16(6):e009960. doi: 10.1161/CIRCHEARTFAILURE.122.009960. Epub 2023 Apr 20.
PubMed 37079511
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation to Optimize Hemodynamic Management of HeartMate II™ Left Ventricular Assist Device Patients Using the CardioMEMS™ Pulmonary Artery Pressure Sensor in Advanced Heart Failure
- ClinicalTrials.gov ID
- NCT03247829
- Acronym / sponsor ID
- INTELLECT 2-HF / SJM-CIP-10178
- Conditions
- Heart Failure
- Keywords
- CardioMEMS, Left Ventricular Assist Device, Hemodynamic Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Posted 26 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional status, quality of life, and readmissions
Detailed description
The study is an observational, single group study where all participants receive the same intervention. The study plans to enroll up to 100 patients at 25 US sites. All patients will have a HeartMate Left Ventricular Assist Device (LVAD) and a CardioMEMS device implanted as standard of care. After enrollment into the study, the patient will be followed until six month follow up completion. The objective of this clinical investigation is to understand the role of hemodynamic monitoring in LVAD patients and:
- Characterize PA pressure measurements with the CardioMEMS HF System in LVAD patients under different clinical and physiologic conditions
- Characterize the effects of PA pressure on functional status, quality of life, and hospital readmissions of LVAD patients
- Evaluate target ranges for PA pressure and assess the impact of medication and pump speed changes on PA pressures
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment | – | Device: Hemodynamic management using CardioMEMS HF SystemPatients with CardioMEMS PA Sensor and LVAD, previously implanted, will receive hemodynamic management using CardioMEMS HF System |
| Group B: Patients with existing HeartMate LVAD implanted with CardioMEMS PA Sensor post enrollment | – | Device: Hemodynamic management using CardioMEMS HF SystemPatients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, will receive hemodynamic management using CardioMEMS HF System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart Failure patients will be recruited from the clinicians practice based on the presence of both devices under study
Key inclusion criteria (5 listed)
- Subject has CardioMEMS HF PA Sensor and a commercially-approved HeartMate LVAD (Group A) OR Subject has commercially-approved HeartMate LVAD, is experiencing NYHA class III symptoms, and has had a previous HF hospitalization and meets FDA indications for CardioMEMS. The CardioMEMS PA Sensor must be implanted within 72 hours of consent (Group B)
- Signed an informed consent form and agreed to provide access to patient and device data (including CardioMEMS Merlin.net data)
- No connectivity or transmission problems with CardioMEMS
- On HeartMate LVAD support for at least 3 months
- Age ≥ 18 years
Key exclusion criteria (3 listed)
- Current participation in an investigation that is likely to confound study results or affect study outcome
- Current participation in the MOMENTUM3 IDE Clinical trial and has not completed the two year follow-up for that trial
- Inability to perform 6MHW test due to conditions other than heart failure (e.g. severe arthritis, orthopedic issues, amputation etc.)
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 |
|---|---|---|
| Hemodynamic management using CardioMEMS HF SystemUsing the CardioMEMS HF System, clinicians will treat to target PA pressure ranges | Device | Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment, Group B: Patients with existing HeartMate LVAD implanted with CardioMEMS PA Sensor post enrollment |
Primary outcome
Six Minute Hall Walk (6MHW) Distance
Time frame: Six Months
Change in 6MHW distance compared to baseline. The six-minute hall walk (6MHW) test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37079511Thohan V, Abraham J, Burdorf A, Sulemanjee N, Jaski B, Guglin M, Pagani FD, Vidula H, Majure DT, Napier R, Heywood TJ, Cogswell R, Dirckx N, Farrar DJ, Drakos SG; INTELLECT 2-HF Investigators. Use of a Pulmonary Artery Pressure Sensor to Manage Patients With Left Ventricular Assist Devices. Circ Heart Fail. 2023 Jun;16(6):e009960. doi: 10.1161/CIRCHEARTFAILURE.122.009960. Epub 2023 Apr 20.
- Individual participant dataSharing planned: No
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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.
Kartik Sundareswaran study director
Abbott
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Abbott Medical Devices at 23 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 5 inclusion and 3 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 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 26 Apr 2024). 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?
Six Minute Hall Walk (6MHW) Distance (time frame: Six Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03247829, which also lists 1 linked publication.
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 26 Apr 2024.