Heart Failure Clinical Trial

Heart Failure Optimization Study

Summary

This study is designed as a multi-center prospective observational study of newly diagnosed Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF) recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is achieved. Although the study doesn't start until day 90, all eligible, consenting patients will be entered into a registry at the start of wearable cardioverter defibrillator (WCD) use. The pre-study registry will allow us to collect early (90 day) outcomes and data in those patients who are likely to be eligible for the study at day 90, or are eligible, but refuse the study at day 90.

View Full Description

Full Description

This study will be conducted at thirty to sixty sites, initially in US and Europe. It will be used to observe the rate of recovery of ventricular function (EF>35%) between 90 and 180 days in newly diagnosed HF patients who were prescribed the WCD ≤ 10 days post-discharge after hospitalization for a primary reason of new onset HF (≤30 days since first HF hospitalization), with ischemic or non-ischemic cardiomyopathy, and have already used a WCD for 90 ± 14 days. For the first 90 days of WCD use, patients will be enrolled in a pre-study registry. The FDA-approved WCD will be prescribed for up to 6 months of use after hospital discharge, with the option for longer use under physician discretion. Approximately 870 subjects will enroll into the pre-study registry and 750 subjects into the study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Part 1

Patients (≥18 years old) who were prescribed the WCD ≤ 10 days post-discharge after hospitalization for a primary reason of new onset HF (≤30 days since first HF hospitalization), with ischemic or nonischemic cardiomyopathy, and have used the WCD for no more than 30 days.
Patients who had an EF ≤ 35% during index hospitalization (must be last measurement if performed multiple times).

Part 2

Patients (≥18 years old) who were prescribed the WCD ≤ 10 days post-discharge after hospitalization for a primary reason of new onset HF (≤30 days since first HF hospitalization), with ischemic or nonischemic cardiomyopathy, and have already used a WCD for 90 ± 14 days.
Patients who had an EF ≤ 35% during index hospitalization (must be last measurement if performed multiple times). Of note, EF at 90 ± 14 days post-hospitalization does not need to be low to be included in the study.

Exclusion Criteria:

Patients under 18 years old.
Patients who have an active unipolar pacemaker.
Patients with a physical or mental condition that could impair their ability to properly interact with the device.
Patients currently participating in another clinical study.
Patients with any skin condition that would prevent wearing the device.
Patients with an advanced directive prohibiting resuscitation.
Patients who are indicated for cardiac resynchronization therapy or have a QRS duration of ≥135 ms.
Patients with recent myocardial infarction or coronary revascularization (since start of WCD wear; i.e. 0-90 days of WCD wear).

Study is for people with:

Heart Failure

Estimated Enrollment:

622

Study ID:

NCT03016754

Recruitment Status:

Completed

Sponsor:

Zoll Medical Corporation

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There are 63 Locations for this study

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UAB Division of Cardiovascular Disease
Birmingham Alabama, 35294, United States
Study Site
West Hills California, 91307, United States
Baptist Heart Specialists
Fernandina Beach Florida, 32034, United States
Baptist Heart Specialists
Jacksonville Beach Florida, 32250, United States
Baptist Heart Specialists
Jacksonville Florida, 32207, United States
Institute of Cardiovascular Research
Ocala Florida, 34471, United States
Research Physicians Network Alliance
Orlando Florida, 32825, United States
Study Site
Saint Petersburg Florida, 33709, United States
Fox Valley Clinical Research Center
Aurora Illinois, 60506, United States
Chicago Medical Research, LLC
Hazel Crest Illinois, 60429, United States
Unity Point Health-Methodist
Peoria Illinois, 61602, United States
Cardiovascular Research of Northwest Indiana, LLC
Munster Indiana, 46321, United States
Beacon Medical Group clinical Research
South Bend Indiana, 26554, United States
Saint Joseph London
London Kentucky, 40741, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Covenant Medical Center, Inc.
Saginaw Michigan, 48602, United States
Jackson Heart Clinic
Jackson Mississippi, 39216, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
SSM Health Heart & Vascular
Lake Saint Louis Missouri, 63367, United States
St. Louis Heart and Vascular
Saint Louis Missouri, 63136, United States
Hackensack Meridian Health
Hackensack New Jersey, 07601, United States
AtlantiCare Regional Medical Center
Pomona New Jersey, 08240, United States
Lourdes Cardiology Services
Voorhees New Jersey, 08043, United States
Trinity Medical Center
Buffalo New York, 14215, United States
SJH Cardiology
Liverpool New York, 13088, United States
UNC Chapel Hill
Chapel Hill North Carolina, 27599, United States
City Cardiology Associates
Barberton Ohio, 44203, United States
Drexel University
Philadelphia Pennsylvania, 19102, United States
Temple University Hospital
Philadelphia Pennsylvania, 19140, United States
Guthrie Medical Group, P.C.
Sayre Pennsylvania, 18840, United States
Carolina Heart Specialists
Lancaster South Carolina, 29720, United States
Sanford Health
Sioux Falls South Dakota, 57104, United States
Methodist University Hospital (MUH) and Methodist OliveBranch (MOB)
Memphis Tennessee, 38104, United States
Methodist South (MS) University Hospital
Memphis Tennessee, 38116, United States
Parkway Cardiology
Oak Ridge Tennessee, 37830, United States
Texas Health Research & Education Institute
Dallas Texas, 75231, United States
Mission Research Insitute
New Braunfels Texas, 78130, United States
Providence Health Center
Waco Texas, 76712, United States
St. Mary's Medical Center
Huntington West Virginia, 25702, United States
Ordensklinikum Linz GmbH/Elisabethinen
Linz , 4020, Austria
Medizinische Universitätsklinik Wien
Vienna , , Austria
Centre Hospitalier Sud Francilien
Corbeil-Essonnes , 91106, France
CHU de Grenoble site Nord- Hopital Albert Michallon
Grenoble , 38043, France
CHU de Clermont-Ferrand- Hopital Albert Michallon
Grenoble , 63003, France
Hopital Europeen Georges Pompidou
Paris , 75015, France
CHU Pontchaillou
Rennes , 35033, France
Clinique Pasteur
Toulouse , 31076, France
Amper Kliniken AG, Heliios Amper-Klinikum Dachau
Dachau Bavaria, 85221, Germany
Klinik u. Polikllinik Fur Innere Med. II Kardiologie
Regensburg Bayern, 93042, Germany
Schwarzwald-Baar Klinik
Villingen-Schwenningen Deutschland, 78052, Germany
Elisabeth-Krankenhaus
Essen NRW, 45138, Germany
Klinikum Augsburg
Augsburg , 86156, Germany
Herz- und Gefäßklinik Bad Neustadt
Bad Neustadt an der Saale , 97616, Germany
Asklepios Klinik Barmbek
Barmbek , 22291, Germany
Charité Universitätsmedizin Berlin
Berlin , , Germany
St. Vinzenz Hospital
Cologne , 50733, Germany
Universitaetsklinikum Duesseldorf
Duesseldorf , 40225, Germany
UKGM, Standort Giessen
Giessen , 35392, Germany
Asklepios Harzklinik Goslar
Goslar , 38642, Germany
Universitatsklinikum Halle
Halle , 06120, Germany
Asklepios Klinik Wandsbek
Hamburg , 22043, Germany
Kardiologie, Asklepios Klinik St. Georg
Hamburg , , Germany
Medizinische Hochschule Hannover
Hannöver , 30625, Germany
Herzzentrum Leipzig GmbH
Leipzig , 04289, Germany
Klinikum Ludenscheid
Ludenscheid , 58515, Germany
Katholisches Klinikum Lunen
Lunen , 44534, Germany
Universitätsklinikum Ulm
Ulm , , Germany

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

622

Study ID:

NCT03016754

Recruitment Status:

Completed

Sponsor:


Zoll Medical Corporation

How clear is this clinincal trial information?

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