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A Phase 3 Global, Double-Blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety if ION-682884 in Patients with Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

To evaluate the efficacy of AKCEA-TTR-LRx , also known as ION-682884, compared to placebo for 120 weeks in patients with ATTR-CM receiving available standard of care (SoC). For more information, please visit https://www.cardio-ttransform.com/.

Primary Investigator: Christopher Mueller, MD
Subinvestigators: Nicole Lohr, MD, PhD

ClinicalTrials.gov Identifier: NCT04136171
Status: Currently Enrolling

A Phase 4 Multicenter Observational Study to Evaluate the Effectiveness of Patisiran in Patients with Polyneuropathy of Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with a V122I or T60A Mutation

To evaluate the effectiveness of patisiran in patients with ATTRv amyloidosis with polyneuropathy who have a V122I or T60A mutation.

Primary Investigator: Christopher Mueller, MD
Subinvestigators: Nicole Lohr, MD, PhD

ClinicalTrials.gov Identifier: NCT04201418
Status: Currently Enrolling

Surveillance HeartCare Outcome Registry

This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.

Primary Investigator: David Ishizawar, MD
Subinvestigators: Nicole Lohr, MD, PhD

ClinicalTrials.gov Identifier: NCT03695601
Status: Currently Enrolling

Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure

The purpose of this study is to determine if Patiromer treatment of subjects who developed hyperkalemia while receiving RAASi medications will result in continued use of RAASi medications in accordance with heart failure (HF) treatment guidelines and thereby decrease the occurrence of the combined endpoint of cardiovascular (CV) death and CV hospitalization events compared with placebo treatment.

Primary Investigator: Nunzio Gaglianello, MD
Subinvestigators: Nicole Lohr ...

Investigational Device Exemption (IDE) Trial Heart Failure NYHA Class III

A Prospective, Multi-Center, Randomized Controlled, Single Blind Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart NYHA Class III Heart Failure Patients.

Primary Investigator: Mitchell Saltzberg, MD
Subinvestigators: Nicole Lohr, MD, PhD; David Marks, MD; Michael Salinger, MD; Diane Book, MD.

ClinicalTrials.gov Identifier: NCT04089059
Status: Currently Enrolling

GORE CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO)

This study will assess the safety and effectiveness of GORE CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.

Primary Investigator: Michael Cinquegrani, MD
Subinvestigators: Nicole Lohr, MD, PhD; David Marks, MD; Michael Salinger, MD; Diane Book, MD

ClinicalTrials.gov Identifier: NCT03821129
Status: Currently ...

Full Title: A prospective, randomized, active (warfarin) controlled, parallel-arm clinical trial to determine if patents with an On-X aortic valve can be maintained safely and effectively on factor Xa inhibitor apixaban

The purpose of this trial is to determine if apixaban is non-inferior to warfarin (INR target range 2.0 - 3.0) for patients with an On-X mechanical heart valve implanted in the aortic position for the primary composite outcome of valve thrombosis and valve-related thromboembolism

Primary Investigator: Paul Pearson, MD PhD

The purpose of this study is to determine efficacy of pomalidomide compared to placebo for the reduction in severity of epistaxis after 24 weeks of treatment.

Investigator: Jake Decker, MD
Sub-Investigator: Patrick Foy, MD

Status: Currently Enrolling

Study Purpose: The objective of this study is to demonstrate the safety and effectiveness of the RelayPro Thoracic Stent-Graft in subjects with acute, complicated Type B aortic dissections.

Investigators: Peter Rossi, MD; Neel Mansukhani, MD; Kellie Brown, MD; Robert Hieb, MD; Brian Lewis, MD; Michael Malinowski, MD; Parag Patel, MD; Joseph Hart, MD; Eric Hohenwalter, MD; Matthew Scheidt, MD; William Rilling, MD; Sarah White, MD; Amanda Smolock, MD

Status: Enrolling

Study Purpose: The study device has been cleared by the U.S. Food and Drug Administration (FDA) and is being evaluated for its on-label clinical use. The study device is designed to block arteries, permanently stopping the flow of blood. It does this by expanding within the artery and filling the space with fibers made of a metal called nitinol. Sitting within these fibers on one end of the device is a thin circular layer of a material, called an occlusion membrane, which is intended to quickly stop the flow of blood within the artery.

The purpose of this study is to assess the clinical use ...

The purpose of this study is to describe clinical features; severity of pulmonary dysfunction; incidence of ICU admission and use of mechanical ventilation and ECMO; ECMO technical characteristics; duration of ECMO; complications; and survival of patients with COVID-19.

Primary Investigator: Lucian Durham III, MD, PhD
Subinvestigators: Paul Pearson, MD, PhD; David Joyce, MD; Lyle Joyce, MD, PhD; Mary Beth Graham, MD; Octavio Falcucci, MD; Amit Taneja, MD; Tracy M. Zundel, MD; Takushi Kohmoto, MD; Jayshil Patel, MD; Angelia Espinal, APP

Status: Currently Enrolling

This study is being done to determine the impact of the TIPS procedure on cardiac (heart) function by collecting data (heart pressures) during the IPS procedure. Immediately after TIPS and at standard follow-up time points, labs and transthoracic echocardiograms (TTE or echo) will also be collected.

Primary Investigator: Eric J. Hohenwalter, MD
Sub-Investigators: Michael Cinquegrani, MD; Aiman Ghufran, MD; Robert A. Hieb, MD; Johnny Hong, MD; Kim Joohyun, MD, PhD; Parag J. Patel, MD, MS; Kaila Redifer Tremblay, MD; William Rilling, MD; Kia Saeian, MD, MS; Matthew Scheidt, MD; Achuthan ...

The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate aortic stenosis (AS) compared with optimized heart failure therapy (OHFT).

Primary Investigator: Michael Salinger, MD
Subinvestigator: Nunzio Gaglianello, MD; Ishizawar, David, MD

Status: Currently enrolling

To establish the safety and effectiveness of the Edwards SAPIEN 3 (Edwards Lifesciences, Irvine, California) Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis

Primary Investigator: Peter Mason, MD
Subinvestigator: Michael Salinger, MD; Paul Pearson, MD; Joshua Meskin, MD; Marc Lazzaro, MD; Panayotis Fasseas, MD

Status: Currently enrolling

Determine if the use of imaging-guided endovascular therapy (EVT) is an effective strategy with which to reduce Post-Thrombotic (PTS) disease severity and improve quality of life (QOL) in patients with established disabling iliac-obstructive post-thrombotic syndrome (DIO-PTS).

Primary Investigator: Eric J. Hohenwalter, MD, FSIR

Status: Currently enrolling

To determine whether daily supplementation with the probiotic Lactobacillus plantarum 299v improves the function of blood vessels in patients with coronary artery disease.

Primary Investigator: Michael Widlansky, MD, MPH

Status: Open to enrollment 

The purpose of this study is to assess among patients with an acute myocardial infarction and a hemoglobin concentration less than 10 g/dL, if a liberal transfusion strategy with a threshold of 10 g/dL reduces the rate of the composite outcome of all-cause mortality or recurrent nonfatal acute myocardial infarction through 30 days following randomization compared to a restrictive transfusion strategy with a threshold of 7 to 8 g/dL.

Primary Investigator: Michael Gitter, MD
Subinvestigators: Nicole Lohr, MD, PhD; David S. Marks, MD, MBA

Status: Currently enrolling

The purpose of this study is to improve walking distance in patients with intermittent claudication by using ischemic preconditioning.

Investigators: Kellie Brown, MD; Brian Lewis, MD, Michael Malinowski, MD; Peter Rossi, MD, Matt Durand, MD; Julie Freed, MD; and David Gutterman, MD

Status: Currently enrolling

The purpose of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with traumatic injury of the descending thoracic aorta (DTA).

Investigators: Peter Rossi, MD; Kellie Brown, MD; Robert Hieb, MD, Brian Lewis, MD; Michael Malinowski, MD, Parag Patel, MD, MS; William Rilling, MD, Sarah White, MD, MS; Neel Mansukhani, MD; Joseph Hart, MD; Matthew Scheidt; Amanda Smolock, MD

Status: Closed

The purpose of this research study is to evaluate whether the TAH-t can support patients with life-threatening irreversible biventricular heart failure who are not eligible for transplantation.

Primary Investigator: David Joyce, MD
Subinvestigators: Lyle Joyce, MD, PhD; Lucian Durham, MD, PhD; Paul Pearson, MD, PhD

Status: Open to enrollment