Condition: Heart Failure · Sponsor: Boston Scientific Corporation
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Key Inclusion Criteria: * Patient is currently in NYHA Class II or III. * For patients with LVEF \>40% measured on most recent available echocardiography within the previous 12 months: * ONE (1) of the following echocardiography findings: LA width (diameter) \>3.8 cm, LA length \>5.0 cm, LA area \>20 cm2, LA volume \>55 ml, LA volume index \>29 ml/m2, LVH defined by septal thickness or posterior wall thickness of \>1.1 cm AND * ONE (1) of the following: Elevated BNP/NT-proBNP as defined by: BNP \>100 pg/ml or NT-proBNP \>300 pg/ml within the previous 90 days for patients not in atrial fibrillation or BNP \>300 pg/ml or NT-proBNP \>900 pg/ml for patients in atrial fibrillation at the time of screening for eligibility OR Documented heart failure hospitalization or unscheduled heart failure IV therapy in the previous 12 months * For patients with LVEF \<40% (for MI patients, measured no less than 30 days post-MI) on most recent available echocardiography within the previous 12 months: * ONE (1) of the following: Elevated BNP/NT-proBNP as defined by BNP \>150 pg/ml or NT-proBNP \>600 pg/ml within the previous 90 days for patients not in atrial fibrillation or BNP \>450 pg/ml or NT-proBNP \>1800 pg/ml for patients in atrial fibrillation at the time of screening for eligibility OR Documented heart failure hospitalization or unscheduled heart failure IV therapy in the previous 12 months * Patient is willing to be monitored in LATITUDE Clarity and use the ICM patient mobile app. * Patient is of legal age to give informed consent and is willing to participate in the trial. Key Exclusion Criteria: * Patient is currently implanted with any other active electronic medical device. * Patient has undergone a heart transplant. * Patient is currently enrolled in another investigational study (excluding registries) without prior written approval from Boston Scientific. * Patient is known to be pregnant at the time of enrollment or plans to become pregnant during study participation. * Patient is diagnosed with amyloidosis or hypertrophic cardiomyopathy.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Grandview Medical Center - Affinity Hospital, LLC | Birmingham, Alabama, United States | — |
| Mobile Infirmary | Mobile, Alabama, United States | — |
| Arrhythmia Research Group | Jonesboro, Arkansas, United States | — |
| John Muir Medical Center | Concord, California, United States | — |
| Scripps Memorial Hospital | La Jolla, California, United States | — |
| VA Loma Linda | Loma Linda, California, United States | — |
| Kaiser Permanenty Los Angeles Medical Center | Los Angeles, California, United States | — |
| University of California - Irvine | Orange, California, United States | — |
| San Diego Cardiac Center | San Diego, California, United States | — |
| Cardiology Associates Medical Group | Ventura, California, United States | — |
| The Cardiac and Vascular Institute | Gainesville, Florida, United States | — |
| North Florida South Georgia VA | Gainesville, Florida, United States | — |
+ 45 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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