Patients living with paroxysmal or persistent atrial fibrillation (afib) are at higher risk for stroke due to the frequent development of multiple blood clots in the left atrial appendage. In many cases, afib patients at high risk for stroke receive long-term medication management using anticoagulants, such as warfarin or apixaban, to reduce the risk of cardiovascular events.
Some patients must discontinue these medications after certain major bleeding events or when they reach a certain age. Other prohibitive factors, including hazardous careers like glass making, make the use of anticoagulants inappropriate.
In some cases, the discontinuation of long-term anticoagulant medications increases the risk of stroke and other cardiovascular events in patients with persistent or paroxysmal afib. The increased risk is due to the higher likelihood of blood clot formation in the left atrial appendage.
Pinnacle FLX Study Evaluates Watchman Procedure for Afib
Boston Scientific created the Watchman device as a permanent solution for people living with non-valvular afib who are at high risk for stroke. Doctors have effectively used older versions of the Watchman device as interventions for patients not eligible for long-term anticoagulant therapy.
Now, Sentara Cardiovascular Research Institute has a new clinical trial investigating the effectiveness of an updated Watchman device and delivery system for the minimally invasive surgical closure of the left atrial appendage. The clinical trial, in collaboration with Boston Scientific, is known as Pinnacle FLX.
The study evaluates the entire updated Watchman procedure, including the device, the delivery system and the surgical technique, to establish its safety and effectiveness. Participants include those who are at high risk for stroke and who are eligible for long-term anticoagulation therapy, but who have valid reasons for pursuing non-pharmacological alternative treatments.
Watchman Device Upgraded for Closure of Left Atrial Appendage
Earlier versions of the Watchman device were approximately the size of a quarter. It opened like an umbrella inside the left atrial appendage, covering and eventually endothelializing over the opening to prevent blood clot escape. The device is now smaller and features the addition of tiny prongs which allow the Watchman to actively pull the left atrial appendage opening closed, almost like a purse string.
The Watchman device is implanted via catheter during a minimally invasive surgical procedure accessing the femoral artery. Following surgery, patients remain on an anticoagulant medication regimen for 45 days, or until the left atrial appendage permanently closes. Depending on the patient’s unique medical history, they may require further therapy with clopidogrel for up to six months.
Is Your Atrial Fibrillation Patient Eligible?
As part of the clinical trial enrollment process, Sentara cardiovascular physicians will select candidates based on the following inclusion criteria:
- Patient has paroxysmal, persistent, permanent or long-term non-valvular atrial fibrillation (afib).
- Patient is eligible for the study’s protocol pharmacological regimen of anticoagulant medications following implantation of the Watchman device.
- Patient may discontinue anticoagulant therapy if the left atrial appendage is sealed.
- Patient’s CHADS2 score is two or greater, or their CHA2DS2-VASc score is three or greater.
- The patient is willing and able to return to Sentara for all follow-up appointments.
Nationwide, the estimated enrollment for the Pinnacle FLX study is close to 500 people. Currently, primary outcome measures will identify and investigate any procedural complications seven days post-op.
If you’re interested in learning more about the Pinnacle FLX study, including enrollment, please contact Sentara Cardiovascular Research Institute’s liaison Chelle Zulick at MRZULICK@sentara.com.