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Heart and Vascular

Clinical Trials

Clinical Trials

Doylestown Health's robust research program offers patients access to a broad range of clinical trials including heart and vascular studies. Clinical trials test new and innovative treatments and therapies, which are a critical part of advancing medicine. All clinical trials offered by Doylestown Health are approved and closely monitored by the IRB (Institutional Review Board).

Learn more about the importance of clinical trials

Doylestown Health Medical Research

The following trials are coordinated by the Doylestown Health Medical Research Department. For more information, please call 215.345.2119.

Active Trials - Open to Enrollment:

  • Narrowing of Carotid Artery (asymptomatic) - CREST-2

    • 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
  • CREST-2 Registry

    • 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
  • TAVR and Atrial Fibrillation – ENVISAGETAVI - AF

    • 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
  • Coronary Artery Disease - PIONEER III

    • 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
  • High Risk Bleeders needing Coronary Stenting – XIENCE- 90

    • 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
  • ADVENT

    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

  • PULSED

    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

Active Trials - Not Accepting New Patients:

  • Coronary Artery Disease - ABSORB III & IV

    • Enrolled patients in follow up through September 2021
  • Coronary Artery Disease – BIONICS

    • Enrolled patients in follow up through August 2020
  • Coronary Artery Disease – PROMUS CLOSED

    • Enrolled patients in follow up through April 2018
  • Heart Attack – ARTEMIS CLOSED

    • Enrolled patients in follow up through December 2017
  • Peripheral Artery Disease - MIMICS-2

    • Enrolled patients in follow up through June 2019
  • Paroxysmal or persistent atrial fibrillation with high blood pressure - SYMPLICITY AF

    • To evaluate the feasibility of performing both renal artery denervation and pulmonary vein isolation on the same patient to characterize both safety and effectiveness in patients with high blood pressure who have paroxysmal (occasional episodes) or persistent (lasting more than seven days) atrial fibrillation.

For more information about Doylestown Health's open trials visit the U.S. National Institutes of Health's Clinical Trials database.

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