Clinical Trials

• Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
• An NIH study for patients who have significant narrowing of the carotid artery who have not experienced stroke symptoms (asymptomatic)
• This four-year study includes close monitoring and intense medical management to reduce stroke risk factors including control of high blood pressure, cholesterol, diabetes, smoking cessation, diet and exercise. The study compares carotid endarterectomy (CEA) with medical management vs carotid stenting (CAS) with medical management vs just medical management
• Open to enrollment

• A companion study to the CREST-2 trail offering CREST-2 approved and conditional approved interventionists an opportunity to expand their expertise in performing CAS so they can fully participate in C2
• All eligible CAS cases performed by study interventionists are registered so they can be reviewed
• Open to enrollment

• Edoxaban (a new, oral anticoagulant) Compared to Standard Care ( Coumadin)After Heart Valve Replacement Using a Catheter in Patients with Atrial Fibrillation
• Patients will be followed for 3 year
• Open to enrollment

• Trial to Assess Safety and Efficacy of a new stent platform for drug eluting stents for the coronary arteries
• Patients will be followed for 5 years
• Open to enrollment

• The objective of this trial is to evaluate safety of a 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing Percutaneous Coronary Intervention (PCI) with a Xience stent.
• Patients are followed for 1 year
• Open to enrollment

Sponsor = FARAPULSE.
Principal Investigator = Dr. John Harding

Pts are randomized to either cryo balloon PVI (50%) or pulse field ablation (50%).

1. Patients with drug-resistant paroxysmal AF meeting ALL the following criteria:
1. Paroxysmal: AF that terminates spontaneously or with intervention within 7 days of onset.
2. Frequency: within 12 months of enrollment: >2 episodes of clinically confirmed symptomatic PAF
   At least one documented episode by a recording such as ECG, event monitor, holter or telemetry strip.
3. Drug Failed: Failed antiarrhythmic drug (AAD) treatment, meaning therapeutic failure of at least one AAD (class I-IV) for efficacy or Intolerance.
2. Patients who are >18 and <75 years of age on day of enrollment
3. Patient participation requirements:
1. Willing and capable of providing Informed Consent to undergo study procedures
2. Willing to participate in all examinations and follow-up visits and tests associated with this clinical Study.

For more information call 215.933.0053

Sponsor = MEDTRONIC.
Principal Investigator = Dr. Rob Sangrigoli.

Patients are ALL receiving PVI via pulse field ablations.Inclusion criteria:

1. Failure of at least one AAD (class I or III) for AF as evidenced by recurrent symptomatic AF, or intolerable side effects due to AAD.
2. A diagnosis of recurrent symptomatic paroxysmal or persistent AF with the following documentation:
   1. Paroxysmal:
      1. Physician’s note indicating symptoms consistent with recurrent self-terminating(within 7 days)AF or paroxysmal AF;
      2. and any 24 continuous ECG recording documenting Persistent AF within 6 months of enrollment;
         OR (2) two ECGs from any form of rhythm monitoring showing continuous AF taken at least 7 days apart.
   2. Persistent:
      1. Physicians note indicating symptoms consistent with continuous AF episode lasting longer than 7 days but less than 1 year:
      2. and any EKG documented AF episode(s) within 12 months prior to enrollment.
3. Age 18-80 years old (or older than 18 if required by law).

For more information, call 215.933.0053