Mitral valve replacement via minimally invasive transcatheter procedure (TMVR)

• Key Inclusion Criteria: Severe mitral valve regurgitation

• Key Exclusion Criteria: Left ventricular ejection fraction ≤ 30%

Principle Investigator: Hiram Bezerra, MD

Studying the efficacy of commercially available lead for left bundle branch area pacing in patients requiring a pacemaker.

• Key Inclusion Criteria: Candidate for implantation of a pacemaker system, per standard guidelines. This includes single chamber, dual chamber, and CRT-P systems

• Key Exclusion:
  1. Already implanted with an implantable cardioverter defibrillator (ICD)
  2. Previous unsuccessful attempt to place lead in left bundle branch area

Principle Investigator: David Wilson, MD

• Patients identified meeting cardiogenic shock criteria at any point during index hospitalization
• Post-cardiotomy patients must meet inclusion criteria at least 72 hours after surgery to be included

Principle Investigator: Hiram Bezerra, MD

New generation Left Atrial Appendage closure device reducing stroke complications due to atrial fibrillation.

• Key Inclusion:
  1. Documented non-valvular atrial fibrillation
  2. Rationale to seek non-pharmacologic alternative to oral anti-coagulation

• Key Exclusion
  1. Medical condition besides atrial fibrillation that mandates long term oral anticoagulation
  2. Recent surgical intervention, myocardial or ischemic event

Principle Investigator: Bibhu Mohanty, MD

Novel treatment device to improve heart function for patients with dilated cardiomyopathy via the AccuCinch system.

• Key Inclusion Criteria: Left ventricular ejection fraction ≥20% and ≤40%

• Key Exclusion Criteria: Severe mitral regurgitation or severe tricuspid regurgitation OR moderate to severe aortic regurgitation.

Principle Investigator: Fadi Matar, MD

Circulatory support device for heart failure patients experiencing Cardio-Renal Syndrome

• Key Inclusion Criteria:
  1. Current admission with decompensated heart failure
  2. Resistance to intravenous diuretics (post 48 hours of 80mg intravenous furosemide or equivalent; or max tolerated dose)

• Key Exclusion Criteria:
  1. Treatment with intravenous inotropes or vasopressors
  2. Prior kidney transplant

Principle Investigator: Robby Wu, DO

Coronary artery imaging device utilizing optical computed tomography (OCT)

• Key Inclusion Criteria: Suspected coronary artery disease requiring treatment

• Key Exclusion Criteria:
  1. Acute ST elevated myocardial infarction (STEMI)
  2. Severe valvular heart disease
  3. Prior heart transplant

Principle Investigator: Hiram Bezerra, MD

Evaluation of His bundle pacing to improve heart function for heart failure patients with right bundle branch block (RBBB)

• Key Inclusion Criteria: New York Heart Association (NYHA) class 2a or 2b patients with right bundle branch block

Principle Investigator: Bengt Herweg, MD

Evaluating a next generation lead for patients requiring an implantable cardioverter-defibrillator (ICD).

• Key Inclusion Criteria: Meeting criteria for implantable cardioverter device (ICD) or implantable cardiac resynchronization device (CRT-D) implantation or upgrade

• Key Exclusion Criteria:
  1. Dexamethasone allergy
  2. Medical conditions preventing defibrillation testing

Evaluation of His bundle pacing vs left bundle branch pacing to improve heart function for patients in heart failure

• Key Inclusion Criteria: Left ventricular ejection fraction ≤ 50%

• Key Exclusion Criteria:
  1. Chagas disease, cardiac sarcoidosis, or amyloidosis
  2. Severe valvular disease

Principle Investigator: Bengt Herweg, MD

Evaluation of novel Factor XI direct oral anticoagulant (DOAC) for stroke risk reduction in patients with atrial fibrillation or atrial flutter

• Key Inclusion Criteria: Atrial fibrillation or atrial flutter requiring anticoagulation

• Key Exclusion Criteria: Any condition other than atrial fibrillation or flutter requiring chronic anticoagulation

Principle Investigator: Dany Sayad, MD

Mitral valve replacement via minimally invasive transcatheter procedure (TMVR)

• Key Inclusion Criteria: Moderate or severe symptomatic mitral valve regurgitation

• Key Exclusion Criteria: Prior transcatheter mitral valve repair or left ventricular ejection fraction < 25%

Principle Investigator: Hiram Bezerra, MD

Aortic valve replacement via minimally invasive transcatheter procedure (TAVR)

• Key Inclusion Criteria: Moderate symptomatic aortic stenosis

• Key Exclusion Criteria: Age <65 or left ventricular ejection fraction <20%

Principle Investigator: Hiram Bezerra, MD

Compassionate usage of mavacamten to improve heart function in patients with non-obstructive hypertrophic cardiomyopathy.

• Key Inclusion Criteria: Unexplained left ventricular hypertrophy contributing to hypertrophic cardiomyopathy.

• Key Exclusion Criteria: Fabry disease, amyloidosis, or Noonan syndrome

Principle Investigator: Thomas McDonald, MD

New patent foramen ovale (PFO) closure device for stroke risk reduction

• Key Inclusion:
  1. Patent foramen ovale defined by microbubble visualization on echo
  2. Cryptogenic stroke within last 270 days

• Key Exclusion:
  1. Intracardiac thrombus
  2. History of atrial fibrillation or other known cause of stroke

Principle Investigator: Bibhu Mohanty, MD

Pulmonary artery sensor system aide for heart failure patients

• Key inclusion Criteria:
  1. New York Heart Association (NYHA) class 3
  2. Heart failure related hospitalization within past 12 months

• Key Exclusion Criteria:
  1. Hypotension or renal dysfunction
  2. History of recurrent pulmonary embolism
  3. Severe valvular disease

Principle Investigator: Joel Fernandez, MD

• PAS for all patients implanted with the CVRx Barostim System.
• Patients must sign ICF after implantation with de novo Barostim System.

Principle Investigator: Fadi Matar, MD

Compassionate usage of bromocriptine to improve heart function in mothers with recently diagnosed peripartum cardiomyopathy.

• Key Inclusion Criteria: Post-partum diagnosis of peripartum cardiomyopathy within the first five months

• Key Exclusion:
  1. Previous diagnosis of cardiomyopathy, valve disease, or congenital heart disease
  2. Post-partum women currently breastfeeding and planning to continue

Principle Investigator: Daniela Crousillat, MD