TCT 2018: Cardiac Dimensions meets endpoints in Carillon trial

Cardiac Dimensions said yesterday that a study of its Carillon mitral valve repair device met its primary endpoint, with the data presented at the annual Transcatheter Cardiovascular Therapeutics meeting in San Diego.

Kirkland, Wash.-based Cardiac Dimensions said the Reduce FMR trial was a sham-compared study of patients treated with Carillon, which is designed to use a distal anchor and proximal anchor, connected by a shaping ribbon, to re-form the mitral annulus by bending the coronary sinus. Late last year the FDA granted an investigational device exemption for a 400-patient pivotal trial of the Carillon device. That pivotal study enrolled its first patients just this month.

Results from the 120-patient Reduce FMR study revealed yesterday showed statistically significant reductions in functional mitral regurgitation in both the treatment arm and an intention-to-treat analysis. Of the 87 patients treated with Carillon, the FMR rate fell -22% after a year, compared with an 8% increase for the 33 patients in the sham control arm.

The study also showed a lower adverse event rate for the treatment arm compared with the control arm, at 16% versus 18%, respectively, with recurrent heart failure hospitalizations at 11% for the treatment arm compared with 21% for the control arm.

Secondary analyses showed that left ventricular end diastolic volumes were reduced in the treatment group and increased for the control arm at a year (-8.6 vs +6.5, respectively); left ventricular end systolic volumes were likewise reduced for the Carillon-treated population but increased for the control arm (-4.8 vs +6.1, respectively.

“I am impressed the trial results are consistent with the positive outcomes I’ve seen in my practice,” Dr. Horst Sievert, who presented the data at TCT 2018, said in prepared remarks. “When we designed this study, we knew a blinded, sham-controlled trial would be challenging, but the validity of the results would therefore be very compelling. And it is.”

“We are pleased with these positive results, which come on the heels of enrollment of the first patient in our Carillon pivotal trial, announced last week – the next step toward bringing the Carillon device to patients in the United States,” added Cardiac DImension CMO Dr. Steve Goldberg. “We look forward to gathering further clinical evidence to increase our understanding of the benefits of the Carillon device.”

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