Current Clinical Trials

HEAL-LAA Clinical Trial; Site # 0752
  1. Leon Feldman, MD
    Leon Feldman, MD
  2. for people 18 Years and up (full criteria)
  3. Rancho Mirage, CA
  4. study started September 2023
  5. Leon Feldman, MD
  6. Accepting new patients

Description

Summary

The purpose of this study is to collect and analyze clinical information on patients who have received the WATCHMAN FLX™ Pro device. The information that is collected in this study may be used in the future to help get this new version of the device on the market outside of the United States.

Official Title

HEAL-LAA: Post-Market Real World Outcomes in WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device

Keywords

Non-valvular Atrial Fibrillation

Eligibility

for people 18 Years and up
Inclusion criteria are listed below. IC1. Subject is of legal age to participate in the study. IC2. Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve). IC3. Subject is clinically indicated for and is treated or attempted to be treated with a WATCHMAN FLX™ Pro device. IC4. Subject or legal representative is able to understand and willing to provide written informed consent ... more
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Inclusion criteria are listed below.
IC1. Subject is of legal age to participate in the study.
IC2. Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve).
IC3. Subject is clinically indicated for and is treated or attempted to be treated with a WATCHMAN FLX™ Pro device.
IC4. Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study.
IC5. Subject is able and willing to return for required follow-up visits and examinations.
Released

Exclusion criteria are listed below.
EC1. Subject has a documented life expectancy of less than 6 months.
EC2. Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment.
EC3. Intracardiac thrombus is present.
EC4. An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present.
EC5. The LAA anatomy will not accommodate a Closure Device.
EC6. The patient has known hypersensitivity to any portion of the device material or the individual components such that the use of the WATCHMAN FLX™ Pro Device is contraindicated.
EC7. Any of the customary contraindications for other percutaneous catheterization procedure (e.g., patient size too small to accommodate TEE probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present.
EC8. There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor.
EC9. Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment per study physician’s discretion).

Lead Scientists at Eisenhower Health

Leon Feldman, MD
Leon Feldman, MD, FACC, has received Board Certification in internal medicine, cardiovascular disease and clinical cardiac electrophysiology. In addition, he also received a Bachelor of Arts degree with distinction in psychology from Cornell University College of Arts and Sciences in Ithaca, New York before attending Tufts University School of Medicine in Boston, Massachusetts. He completed his internship and residency at the UCLA Center for Health Sciences, prior to completing two fellowships i... more
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Leon Feldman, MD, FACC, has received Board Certification in internal medicine, cardiovascular disease and clinical cardiac electrophysiology. In addition, he also received a Bachelor of Arts degree with distinction in psychology from Cornell University College of Arts and Sciences in Ithaca, New York before attending Tufts University School of Medicine in Boston, Massachusetts. He completed his internship and residency at the UCLA Center for Health Sciences, prior to completing two fellowships in cardiology and cardiac electrophysiology at Oregon Health and Science University in Portland.

I went into cardiology because I thought it was the most fascinating aspect of internal medicine,” says Dr. Feldman. “The heart is at the core of a patient’s physical and emotional life.  I am honored by the trust patients and their families give me every time I step into the electrophysiology laboratory to perform a procedure or study.”

Dr. Feldman treats people with all aspects of cardiovascular disease but has special training and interest in cardiac arrhythmias. “The first time I put on a gown and mask to perform a procedure I was hooked,” says Dr. Feldman. “One aspect of my work is to implant pacemakers and defibrillators for patients with serious heart rhythm issues. These devices are small sophisticated electronic marvels and save patient’s lives.” 

As Co-Director of the Electrophysiology (EP) Laboratory/Arrhythmia Center at Eisenhower Medical Center, Dr. Feldman’s expertise includes implanting pacemakers, defibrillators, heart failure devices and performing cardiac ablations. He remains actively involved in bringing the latest technologies and techniques to the EP lab for patients in the Coachella Valley. 

“Atrial fibrillation ablation has become main stream during the last five years. I consider it to be the closest thing to a permanent fix,” says Dr. Feldman. “This technology has progressed so rapidly that the procedure can be done in under an hour with limited need for sedation. We can often treat the very sickest heart disease patients and offer them hope.” 

Dr. Feldman remains active in clinical research, being involved in numerous trials since joining the staff at Eisenhower Medical Center, often serving as primary site investigator. Dr. Feldman also teaches cardiology and electrophysiology to the interns and residents at Eisenhower.

“Eisenhower has been my only job post fellowship, and I feel very lucky,” explains Dr. Feldman. “I think Eisenhower Desert Cardiology Center is a premier cardiology group, representing all major facets of cardiology. All of my colleagues are highly trained. You are not likely to find a problem in cardiology that one of us hasn’t treated during our training or experience.”

 

 

Clinical Study Details

  1. Accepting new patients
  2. study started September 2023
  3. Interventional
  4. April 11, 2024