Heart Failure With Reduced Ejection FractionCardioClipNCT06241430
The CardioClip Study
A study testing CardioMEMS in people with Heart Failure With Reduced Ejection Fraction and Mitral Regurgitation, run by Columbia University at 1 site in United States.
Trial summary
The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Mitral Regurgitation
- What is being tested?
- CardioMEMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2024to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Significant (moderate-severe [3+] or severe [4+] secondary MR)
- Left ventricular dysfunction (ejection fraction >20% and <50%)
- New York Heart Association (NYHA) class II-IVa symptoms
- Sign informed consent to participate in the study
Who cannot join
- Left ventricular (LV) end-systolic dimension 70 mm
- PA systolic pressure 70 mmHg (fixed)
- Mitral valve (MV) orifice area <4.0 cm2
- Commissural MR jet or leaflet anatomy not suitable for mTEER
- Likely to undergo heart transplantation or LV assist device implantation in the next 12 months
- Recurrent (i.e., >1) pulmonary embolism or deep vein thrombosis
Show all 11Show fewer
- Complex congenital heart disease
- Mechanical right heart valve (tricuspid or pulmonic)
- Cardiac resynchronization therapy implanted within 3 months of enrollment
- Hypersensitivity to aspirin and/or clopidogrel
- History of medication non-adherence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, 10032
Kate Dalton, MS, RD, CCRC, keb2114@cumc.columbia.edu
Nir Uriel, MD
About this study
Official title: Hemodynamic-Guided Optimization With the CardioMEMS Device of Patients With Heart Failure and Secondary Mitral Regurgitation Undergoing Mitral Transcatheter Edge-to-Edge Repair With the MitraClip Device
The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin. The investigators want to find out if the sensor, by constantly sending information about heart function, can help improve patient outcomes. This means doctors could adjust medications based on real-time pressure changes detected by the sensor. The results from this study will help pave the way for future trials, asking if using these wireless sensors could benefit people with valve disease and heart failure.
Read the detailed description
Patients with heart failure suffer considerably. They experience an increased risk of death and are hospitalized with symptoms of heart failure frequently. Often times, heart failure results in abnormal function of the mitral valve (one of the key valves separating the heart's main pumping chamber - the left ventricle - from the left atrium, which collects oxygenated blood from arteries in the lung). This abnormal function causes the valve to leak - a condition called mitral regurgitation - that perpetuates and can exacerbate heart failure.
Recently, researchers have developed a procedure for patients with mitral regurgitation in the setting of heart failure called mitral transcatheter edge-to-edge repair (mTEER). In this procedure, a "clip" is deployed to grasp the mitral valve leaflet and re-approximate them, thereby reducing the amount of mitral regurgitation. This procedure is performed by accessing one of the large veins in the body and no surgical intervention is required. Patients typically recover within 24 hours and are discharged home without the prolonged recovery periods associated with traditional therapies for mitral regurgitation like open heart surgery and mitral valve repair or replacement. Moreover, the procedure is exceedingly safe, with a very low risk of significant adverse complications.
While mTEER reduces the risk of death and hospitalization for heart failure compared with the standard of care (i.e., medicines geared at improving heart function), many patients still suffer significant adverse events within a five year period. Accordingly, the investigators are interested in identifying strategies to further improve outcomes for patients with heart failure and significant mitral regurgitation. The CardioClip study endeavors to use another technology - a wireless pulmonary artery pressure sensor - that is implanted in a similar fashion to the way mTEER is performed (i.e., percutaneously, without surgery, through one of the veins in the groin), to see whether clinical outcomes can be improved further. The sensor continuously transmits information regarding heart function to clinicians who can optimize medications and their doses according to dynamic changes in pressure noted by the sensor.
- Being tested
- CardioMEMS
- Keywords
- Heart failure, Reduced ejection fraction, Mitral regurgitation, mTEER (mitral transcatheter edge-to-edge repair), CardioMems (implantable pulmonary artery pressure sensor), Guideline-directed medical therapy (GDMT), HF hospitalization (HFH), Clinical trial, Hemodynamic monitoring, Cardiovascular outcomes
- Medical subject headings
- Mitral Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioMEMSDevice
Hemodynamic-guided optimization will be performed using the CardioMEMS CardioClip device.
| Study group | Role | What they receive |
|---|---|---|
| CardioMems | Experimental | Participants randomized to this arm will receive hemodynamic-guided GDMT titration with CardioMems. Receives: Device: CardioMEMS |
| Usual Care | No intervention | Participants randomized to this arm will receive usual care involving GDMT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score between baseline (pre-mTEER) and 12 months after mTEER.
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. To facilitate interpretation, all scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life (i.e., higher score indicates a better outcome). The Overall Summary (OS) score is the mean of four subdomain scores, each ranging from 0 to 100. A higher OS score indicates better outcome.
Measured: 12 months
Secondary outcomes (20)
All-cause mortality rate at 12 months
All-cause mortality rate will be calculated at 12 months.
Measured: 12 months
Rate of HFH at 12 months
Heart failure hospitalization (HFH) rate will be calculated.
Measured: 12 months
Number of participants who achieve excellent clinical outcome
An excellent clinical outcome is defined by a) survival, b) KCCQ-OS >60 points, and c) no decline ≥10 points in the KCCQ-OS relative to baseline at 12 months
Measured: 12 months
KCCQ score - Physical Function domain
The KCCQ-OS evaluates health status from four principal domains: physical function, social function, symptoms, and quality of life. Participants receive a score for 0 to 100 in each domain, with higher scores indicating better health status in that specific domain. The score for each domain will be an individual secondary endpoint.
Measured: Baseline, 1 month, 6 months, 12 months post-mTEER
KCCQ score - Social Function domain
The KCCQ-OS evaluates health status from four principal domains: physical function, social function, symptoms, and quality of life. Participants receive a score for 0 to 100 in each domain, with higher scores indicating better health status in that specific domain. The score for each domain will be an individual secondary endpoint.
Measured: Baseline, 1 month, 6 months, 12 months post-mTEER
KCCQ score - Symptoms domain
The KCCQ-OS evaluates health status from four principal domains: physical function, social function, symptoms, and quality of life. Participants receive a score for 0 to 100 in each domain, with higher scores indicating better health status in that specific domain. The score for each domain will be an individual secondary endpoint.
Measured: Baseline, 1 month, 6 months, 12 months post-mTEER
KCCQ score - Quality of Life domain
The KCCQ-OS evaluates health status from four principal domains: physical function, social function, symptoms, and quality of life. Participants receive a score for 0 to 100 in each domain, with higher scores indicating better health status in that specific domain. The score for each domain will be an individual secondary endpoint.
Measured: Baseline, 1 month, 6 months, 12 months post-mTEER
Change in New York Heart Association (NYHA) Classification at 1-, 6-, and 12-months post-mTEER relative to baseline.
The different classes in the NYHA Classification of Heart Failure are:
Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.
Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.
Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.
Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Measured: Baseline, 1 month, 6 months, 12 months
6-minute walk test (6MWT) at 12 months
The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. The score of the test is the distance a patient walks in 6 minutes at 12 months.
Measured: 12 months
Change in 6-minute walk test (6MWT) from baseline to 12 months
The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. The score of the test is the distance a patient walks in 6 minutes. Change of score at baseline and then at 12 months will be calculated.
Measured: Baseline and 12 months
Win ratio
Win ratio for the hierarchical endpoint of KCCQ improvement ≥10 points at 12 months, NYHA functional class improvement ≥1 class at 12 months, 6MWT improvement ≥30 meters at 12 months, HFH at 12 months, and all-cause mortality at 12 months.
Measured: Baseline and 12 months
Echocardiographic estimates of RV-PA coupling indices
Right ventricular (RV)-pulmonary arterial (PA) (RV-PA) coupling indices will be measured (mm/mmHg) will be measured to determine how the right ventricle and pulmonary circulation interact.
Measured: 12 months
Device-related (MitraClip) complications at 12 (single-leaflet device detachment, device embolization, endocarditis requiring surgery, mitral stenosis requiring surgery)
MitraClip complications
Measured: 12 months
Single-leaflet Device Detachments
Device-related MitraClip complications: Total number of single-leaflet device detachment events.
Measured: 12 months
Device Embolizations (MitraClip)
Device-related MitraClip complications: Total number of device embolizations.
Measured: 12 months
Endocarditis (Requiring Surgery)
Device-related MitraClip complications: Total number of endocarditis events requiring surgery.
Measured: 12 months
Mitral Stenosis (Requiring Surgery)
Device-related MitraClip complications: Total number of mitral stenosis events requiring surgery.
Measured: 12 months
Device- or System-related Failures
Device-related CardioMEMS complications: Total number of device- or system-related failures.
Measured: 12 months
In Situ Pulmonary Thrombosis
Device-related CardioMEMS complications: Total number of in situ pulmonary thrombosis.
Measured: 12 months
Device Embolizations (CardioMEMS)
Device-related CardioMEMS complications: Total number of device embolizations
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start18 Dec 2024
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Evaluating the effect of hemodynamic-guided GDMT titration with CardioMems on HFH in individuals with functional MR and HF undergoing mTEER, compared to usual care involving GDMT.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Nir Uriel, Columbia University
- Investigators
- Nir Uriel, MD, Principal investigator, Columbia UniversityMichael Brener, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241430
- Sponsor's protocol ID
- AAAU9731
- Other IDs
- 1K23HL177311-01A1
- Acronym
- CardioClip
- Status last verified
- Jun 2026
- First submitted
- 27 Jan 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic-Guided Optimization With the CardioMEMS Device of Patients With Heart Failure and Secondary Mitral Regurgitation Undergoing Mitral Transcatheter Edge-to-Edge Repair With the MitraClip Device
- ClinicalTrials.gov ID
- NCT06241430
- Acronym / sponsor ID
- CardioClip / AAAU9731
- Keywords
- Heart failure, Reduced ejection fraction, Mitral regurgitation, mTEER (mitral transcatheter edge-to-edge repair), CardioMems (implantable pulmonary artery pressure sensor), Guideline-directed medical therapy (GDMT), HF hospitalization (HFH), Clinical trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Abbott, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 5 Feb 2024 (actual)
- 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 CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin. The investigators want to find out if the sensor, by constantly sending information about heart function, can help improve patient outcomes. This means doctors could adjust medications based on real-time pressure changes detected by the sensor. The results from this study will help pave the way for future trials, asking if using these wireless sensors could benefit people with valve disease and heart failure.
Detailed description
Patients with heart failure suffer considerably. They experience an increased risk of death and are hospitalized with symptoms of heart failure frequently. Often times, heart failure results in abnormal function of the mitral valve (one of the key valves separating the heart's main pumping chamber - the left ventricle - from the left atrium, which collects oxygenated blood from arteries in the lung). This abnormal function causes the valve to leak - a condition called mitral regurgitation - that perpetuates and can exacerbate heart failure.
Recently, researchers have developed a procedure for patients with mitral regurgitation in the setting of heart failure called mitral transcatheter edge-to-edge repair (mTEER). In this procedure, a "clip" is deployed to grasp the mitral valve leaflet and re-approximate them, thereby reducing the amount of mitral regurgitation. This procedure is performed by accessing one of the large veins in the body and no surgical intervention is required. Patients typically recover within 24 hours and are discharged home without the prolonged recovery periods associated with traditional therapies for mitral regurgitation like open heart surgery and mitral valve repair or replacement. Moreover, the procedure is exceedingly safe, with a very low risk of significant adverse complications.
While mTEER reduces the risk of death and hospitalization for heart failure compared with the standard of care (i.e., medicines geared at improving heart function), many patients still suffer significant adverse events within a five year period. Accordingly, the investigators are interested in identifying strategies to further improve outcomes for patients with heart failure and significant mitral regurgitation. The CardioClip study endeavors to use another technology - a wireless pulmonary artery pressure sensor - that is implanted in a similar fashion to the way mTEER is performed (i.e., percutaneously, without surgery, through one of the veins in the groin), to see whether clinical outcomes can be improved further. The sensor continuously transmits information regarding heart function to clinicians who can optimize medications and their doses according to dynamic changes in pressure noted by the sensor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Evaluating the effect of hemodynamic-guided GDMT titration with CardioMems on HFH in individuals with functional MR and HF undergoing mTEER, compared to usual care involving GDMT.
| Arm | Type | Receives |
|---|---|---|
| CardioMems | Experimental | Device: CardioMEMSParticipants randomized to this arm will receive hemodynamic-guided GDMT titration with CardioMems. |
| Usual Care | No intervention | –Participants randomized to this arm will receive usual care involving GDMT. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Significant (moderate-severe [3+] or severe [4+] secondary MR)
- Left ventricular dysfunction (ejection fraction >20% and <50%)
- New York Heart Association (NYHA) class II-IVa symptoms
- Sign informed consent to participate in the study
Key exclusion criteria (11 listed)
- Left ventricular (LV) end-systolic dimension 70 mm
- PA systolic pressure 70 mmHg (fixed)
- Mitral valve (MV) orifice area <4.0 cm2
- Commissural MR jet or leaflet anatomy not suitable for mTEER
- Likely to undergo heart transplantation or LV assist device implantation in the next 12 months
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 |
|---|---|---|
| CardioMEMSHemodynamic-guided optimization will be performed using the CardioMEMS CardioClip device. | Device | CardioMems |
Primary outcome
The change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score between baseline (pre-mTEER) and 12 months after mTEER.
Time frame: 12 months
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. To facilitate interpretation, all scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life (i.e., higher score indicates a better outcome). The Overall Summary (OS) score is the mean of four subdomain scores, each ranging from 0 to 100. A higher OS score indicates better outcome.
20 secondary outcomes
All-cause mortality rate at 12 months
Time frame: 12 months
Rate of HFH at 12 months
Time frame: 12 months
Number of participants who achieve excellent clinical outcome
Time frame: 12 months
KCCQ score - Physical Function domain
Time frame: Baseline, 1 month, 6 months, 12 months post-mTEER
KCCQ score - Social Function domain
Time frame: Baseline, 1 month, 6 months, 12 months post-mTEER
KCCQ score - Symptoms domain
Time frame: Baseline, 1 month, 6 months, 12 months post-mTEER
KCCQ score - Quality of Life domain
Time frame: Baseline, 1 month, 6 months, 12 months post-mTEER
Change in New York Heart Association (NYHA) Classification at 1-, 6-, and 12-months post-mTEER relative to baseline.
Time frame: Baseline, 1 month, 6 months, 12 months
6-minute walk test (6MWT) at 12 months
Time frame: 12 months
Change in 6-minute walk test (6MWT) from baseline to 12 months
Time frame: Baseline and 12 months
Win ratio
Time frame: Baseline and 12 months
Echocardiographic estimates of RV-PA coupling indices
Time frame: 12 months
Device-related (MitraClip) complications at 12 (single-leaflet device detachment, device embolization, endocarditis requiring surgery, mitral stenosis requiring surgery)
Time frame: 12 months
Single-leaflet Device Detachments
Time frame: 12 months
Device Embolizations (MitraClip)
Time frame: 12 months
Endocarditis (Requiring Surgery)
Time frame: 12 months
Mitral Stenosis (Requiring Surgery)
Time frame: 12 months
Device- or System-related Failures
Time frame: 12 months
In Situ Pulmonary Thrombosis
Time frame: 12 months
Device Embolizations (CardioMEMS)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- 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.
Nir Uriel, MD principal investigator
Columbia University
Michael Brener, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardioMEMS in people with Heart Failure With Reduced Ejection Fraction and Mitral Regurgitation, run by Columbia University 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 11 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kate Dalton, MS, RD, CCRC ((347) 514-3366, keb2114@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score between baseline (pre-mTEER) and 12 months after mTEER. (time frame: 12 months). 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 29 Jun 2026.