Health TrialsbyHealthPanel

The CardioClip Study

ConditionsHeart Failure With Reduced Ejection FractionMitral Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorColumbia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • CardioMEMS

    Device

    Hemodynamic-guided optimization will be performed using the CardioMEMS CardioClip device.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: CardioMemsExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

All-cause mortality rate at 12 months

All-cause mortality rate will be calculated at 12 months.

Time frame
12 months
2

Rate of HFH at 12 months

Heart failure hospitalization (HFH) rate will be calculated.

Time frame
12 months
3

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

Time frame
12 months
4

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.

Time frame
Baseline, 1 month, 6 months, 12 months post-mTEER

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

Abbott

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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