Information for Healthcare Professionals
Cardiac Dimensions is reimagining the solutions available to patients suffering from heart failure (HF) with a completely different treatment approach to help patients live longer, higher quality lives.
Our Carillon Mitral Contour System® is a groundbreaking, non-surgical device developed with the goal to safely and effectively treat patients with mitral valve insufficiency.
The Carillon Therapy is the only indirect, no-touch, mitral valve repair option designed to produce an annuloplasty effect (i.e. cinching of the valve annulus). International studies have shown that patients treated with the Carillon Therapy often experience positive left ventricular remodeling and have favorable long-term (3-year) survival.1, 2, 3 The Carillon Device is a right-heart transcatheter mitral valve repair (TMVr) device designed to treat the main cause of functional mitral regurgitation (FMR)—not just the symptoms. The Carillon Therapy can also be used alongside other heart failure treatments should they be needed.4, 5
The distal and proximal anchors of the Carillon Device are connected by a shaping ribbon that utilizes the heart’s venous anatomy to cinch the mitral apparatus.
BEFORE Carillon Implant
AFTER Carillon Implant
The Carillon Implant is deployed using familiar catheter techniques. In addition, real time assessments of implant deployment safety and MR reduction efficacy can be assessed prior to release of the implant. This allows for complete recapture of the implant – if necessary.
Additional benefits of this simple right-heart approach include:
- No transseptal puncture
- Short 1-hour average implant time1,2,3
- Ability to treat less sick (MR grade 2+) patients
- Preserves future treatment options such as CRT
- Conscious sedation
- 10 Fr venous access
- No long-term DAPT
- Short user learning curve
To date, four separate trials have evaluated the safety and performance of the Carillon Therapy—AMADEUS, TITAN, TITAN II, and REDUCE FMR. The latest, the REDUCE FMR Trial, was a landmark fully randomized, blinded, sham-controlled trial of patients. A fifth U.S. pivotal trial, the EMPOWER Trial, is currently enrolling in the United States as well as select other geographies worldwide.
Results show that FMR patients treated with the Carillon Therapy experienced a mean acute regurgitant volume (RV) reduction of 8 ml and had favorable long-term (3-year) survival.6,7 In addition, the majority of the patients experience positive results in mechanistic and clinical end points through 12 months.
Results from the latest completed trial, REDUCE FMR, are summarized below.
REDUCE FMR Clinical Trial
The Carillon Therapy is the only TMVr therapy to demonstrate favorable left ventricular remodeling at one year and a significant reduction in RV in a double-blinded, randomized, sham-controlled trial (REDUCE FMR). The trial met its primary endpoints and results were consistent with the prior TITAN and TITAN II single-arm, multi-center studies.1,2,3
Key inclusion criteria
- MR Grade 2+ to 4+
- NYHA Class II–IV
- LVEF ≤50%
As a result of site assessed MR grade for the inclusion of patients (and subsequently reviewed by an independent core lab), the following breakout of patients by MR grade were enrolled in the trial:
Characteristics of Randomized Patients at Baseline According to ITT Analysis
|Total (N = 120)||Control (n = 33)||Treatment (n = 87)|
|Men||87 (72.5)||24 (72.7)||63 (72.4)|
|Mean age, yrs||69.8 ± 9.5||69.1 ± 8.9||70.1 ± 9.7|
|Ischemic heart disease||80 (66.7)||21 (63.6)||59 (67.8)|
|Nonischemic cardiomyopathy||40 (33.3)||12 (36.4)||28 (32.2)|
|Diabetes mellitus||36 (30.0)||12 (36.4)||24 (27.6)|
|BMI, kg/m2||27.1 ± 5.6||28.1 ± 6.2||26.7 ± 5.3|
|NYHA functional class|
|II||55 (45.8)||16 (48.5)||39 (44.8)|
|III||63 (52.5)||17 (51.5)||46 (52.9)|
|IV||2 (1.7)||0 (0.0)||2 (2.3)|
|Beta blockers||109 (90.8)||32 (97.0)||77 (88.5)|
|ACE inhibitor/ARB/ARNi||108 (90.0)||29 (87.9)||79 (90.8)|
|Diuretic agent||118 (98.3)||33 (100)||85 (97.7)|
|MRA diuretic agent||73 (60.8)||19 (57.6)||54 (62.1)|
|NT-pro-BNP||2,430 (1,092-4,440)||2,410 (1,151-4,820)||2,505 (1,095-4,386)|
|Device (ICD or PPM)||55 (45.8)||12 (36.4)||43 (49.4)|
|Atrial fibrillation||71 (59.2)||20 (60.6)||51 (58.6)|
|Baseline heart rate, beats/min||70 ± 12||70 ± 11||70 ± 13|
|Systolic BP, mmÿHg||119 ± 17||119 ± 19||118 ± 16|
|Diastolic BP, mmÿHg||70 ± 11||67 ± 13||71 ± 11|
|6-min walk test||302.6 ± 90.6||292.6 ± 91.5||306.4 ± 90.5|
|LVEF, %||34 ± 9||37 ± 9||34 ± 9|
|LVEDD, cm||6.4 ± 0.9||6.4 ± 0.9||6.4 ± 0.9|
|LVESD, cm||5.5 ± 1.0||5.3 ± 1.1||5.5 ± 1.0|
|LVEDV, ml||187.4 ± 67.9||188.6 ± 75.7||187.0 ± 65.6|
|LVESV, ml||126.1 ± 56.8||122.0 ± 59.8||127.4 ± 56.1|
|Mitral regurgitant volume, ml/beat||39.9 ± 23.8||38.1 ± 24.0||40.4 ± 23.9|
|Mitral regurgitant grade|
|1+||35 (29.7)||10 (32.3)||25 (28.7)|
|2+||42 (35.6)||8 (25.8)||34 (39.1)|
|3+||34 (28.8)||11 (35.5)||23 (26.4)|
|4+||7 (5.9)||2 (6.5)||5 (5.7)|
|Mean creatinine, mmol/l||114.1 ± 31.9||118.8 ± 34.1||112.3 ± 31.1|
Values are n (%), mean ± SD, or median (interquartile range). There were no significant differences between the groups on appropriate post hoc testing. Conversion factors: creatinine mmol/l × 0.011 = mg/dl.
ACE = angiotensin-converting enzyme inhibitor; ARB = aldosterone receptor blocker; ARNi = angiotensin receptor-neprilysin inhibitor; BMI = body mass index; BP = blood pressure; ICD = implantable cardioverter-defibrillator; ITT = intention to treat; LVEDD = left ventricular end-diastolic diameter; LVEDV = left ventricular end-diastolic volume; LVEF = left ventricular ejection fraction; LVESD = left ventricular end-systolic diameter; LVESV = left ventricular end-systolic volume; MRA = mineralocorticoid receptor antagonists; NT-pro-BNP = N-terminal pro–B-type natriuretic peptide; NYHA = New York Heart Association; PPM = permanent pacemaker.
Despite treating patients across all MR grades, including those with less severe regurgitation (i.e., MR 1+), the study still showed significance in its end points.
Change in regurgitant volume at one year, as assessed by a blinded, independent echo core lab.
120 patients in EU and Australia randomized 3:1
- 87 randomized to treatment (Carillon Therapy)
- 33 randomized to sham control (guideline-directed medical therapy)
Significant Reduction in Regurgitant Volume
Significant Favorable Left Ventricular Remodeling
Recurrent Heart Failure Hospitalizations and Total Heart Failure Admissions
AT = As-Treated Population (n=106)
ITT = Intention-to-Treat Population (n=120)
Positive Safety Profile
- 98.9% freedom from device-related major adverse events through 1 year*
- Low major adverse event rate at 30 days and 12 months in treatment-only group
*Events adjudicated by independent committee as related to device.
U.S. EMPOWER Clinical Trial Now Enrolling
IFU and MRI Information
- Siminiak T, et. al. Treatment of functional mitral regurgitation by percutaneous annuloplasty: Results of the TITAN Trial. Eur J Heart Fail. 2012;14:931-38.
- Lipiecki J, Siminiak T, Sievert H, et al. Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial. BMJ Open Heart. 2016; 3: e000411.
- Witte K, et al. A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation: The REDUCE FMR Trial. J Am Coll Cardiol HF. DOI: 10.1016/j.jchf.2019.06.011.
- Hoppe UC, Brandt MC, Degen H, et al. Percutaneous mitral annuloplasty device leaves free access to cardiac veins for resynchronization therapy. Catheter Cardiovasc Interv. 2009;74(3):506-11.
- Latib, A. “Coronary Sinus Annuloplasty.” New York, Montefiore Medical Center.
- Stöbe, Stephan, et al. “Echocardiographic Analysis of Acute Effects of Percutaneous Mitral Annuloplasty on Severity of Secondary Mitral Regurgitation.” ESC Heart Failure, 2 May 2020, doi:10.1002/ehf2.12719.
- Lipiecki, D.M. Kaye, K.K. Witte, et al., Long-term survival following transcatheter mitral valve repair: Pooled analysis of prospective trial…, Cardiovascular Revascularization Medicine.
- Data on file. Percent change calculated by averaging individual patient percent changes.
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NOTE: The Carillon Mitral Contour System has received CE Mark (0344) and is available for sale in Europe and other countries that recognize CE Mark.
CAUTION: Investigational Device. Limited by United States law to investigational use.