6 days ago
Mon Medical Center participates in trial for device that could revolutionize Afib treatment
dbeard@
MORGANTOWN – Vandalia Health Mon Medical Center is participating in a clinical trial that could forever change how patients with atrial fibrillation are treated.
The trial is called Catalyst, for the Abbott Medical Devices Amplatzer Amulet Left Atrial Appendage Occluder.
The Amulet is already in use for Afib patients who can't use oral anticoagulants (blood thinners), said Dr. Wissam Gharib, who is leading the trial at Mon Medical.
But this could broaden its use to all Afib patients, he said.
This trial, he said, follows a similar trial, called Champion-AF, for the Watchman device by Boston Scientific.
If the trials are successful, he said, 'This will be a paradigm shift in how we treat patients.'
Abbott describes Afib as irregular electrical impulses in the upper chambers of the heart that cause those chambers to fibrillate, or quiver. This results in an irregular and frequently rapid heart rate that affects the heart's ability to pump blood, allowing blood to pool and collect in the left atrial appendage.
Abbott explains that there is a muscular pouch connected to the left atrium of the heart called the left atrial appendage. If the blood clots are pumped from the appendage out into the body, the clots may flow to the brain and lead to stroke.
The Amulet and the Watchman are both inserted via catheter to seal off the left atrial appendage.
Gharib explains that patients diagnosed with Afib are first treated with blood thinners. For those who can't tolerate the medications, the Amulet and the Watchman provide an alternative approved by the FDA.
The Catalyst and Champion trials, he said, aim to learn if the devices function as well as blood thinners and could be offered as an immediate alternative to blood thinners for everyone.
Blood thinners, he said, carry various costs: among them are bleeding, clearances for dental work, pausing for surgical procedures, and the financial costs of being on the medications for life. If the trials prove the devices are as good as a blood thinner, a patient will have a choice.
'That's where these two trials are really pivotal in how we treat atrial fibrillation,' he said.
The Champion trial – conducted at 141 locations, including Mon Medical – is complete and waiting on five-year results.
Catalyst – being conducted at 132 locations, including Mon Medical – under way. Gharib said they have performed a number of procedures already and are still enrolling participants. He expects this portion of the trial will conclude at the end of the year.
Volunteers are split into two groups: half get the Amulet, half get blood thinners. Participants have regular follow-up appointments for the five-year study period.
Patients will know within a few weeks if the Amulet is working, he said, but the five-year period monitors long-term results and effects.
