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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03579641




Registration number
NCT03579641
Ethics application status
Date submitted
4/06/2018
Date registered
6/07/2018

Titles & IDs
Public title
Precision Event Monitoring for Patients With Heart Failure Using HeartLogic
Scientific title
Precision Event Monitoring for Patients With Heart Failure Using HeartLogic: PREEMPT-HF
Secondary ID [1] 0 0
PREEMPT-HF
Universal Trial Number (UTN)
Trial acronym
PREEMPT-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Defibrillators, Implantable 0 0
Monitoring, Physiologic 0 0
Cardiac Resynchronization Therapy 0 0
Cardiovascular Disease 0 0
Heart Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - HeartLogic Sensors

Implantable Cardiac device with HeartLogic feature - Patients with Heart Failure, implanted with Boston Scientific Implantable Cardioverter Defibrillator or Defibrillator with Cardiac Resynchronization device with HeartLogic feature


Treatment: Devices: HeartLogic Sensors
HeartLogic Sensors
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Association of HeartLogic sensors with 30-day HF re-admission
Timepoint [1] 0 0
Heartlogic sensor data will be evaluated for the association to HF re-admission during the 30 days after the index event (e.g. the first HF hospitalization that occurs during the trial).

Eligibility
Key inclusion criteria
* Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws.
* Subject has a documented diagnosis of heart failure.
* Subject has a Boston Scientific Cardiac Resynchronization Therapy Defibrillator or Implantable Cardioverter Defibrillator device implant that has HeartLogic, with Heart Failure Sensors turned ON, Respiratory Sensor turned ON, and Sleep Incline Sensor turned ON.
* Subject has an active bipolar right ventricle lead implant.
* Subject is enrolled in LATITUDE (NXT 5.0 or future version), and is willing to be remotely monitored from the baseline visit for approximately 12 months with HeartLogic disabled.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject has received or is scheduled to receive a heart transplant or ventricular assist device (VAD).
* Subject is enrolled in any concurrent clinical study without prior Boston Scientific written approval (excluding registries).
* Subject has a life expectancy of less than 12 months.
* Subject has a history of non-compliance to medical care or known inability to comply with requirements of the clinical study protocol

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/10/2021
Sample size
Target
Accrual to date
Final
2184
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 0 0
- Chermside
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Maine
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Mississippi
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
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United States of America
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New York
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United States of America
State/province [17] 0 0
North Carolina
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United States of America
State/province [18] 0 0
Ohio
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United States of America
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Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
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United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
United States of America
State/province [26] 0 0
West Virginia
Country [27] 0 0
Belgium
State/province [27] 0 0
Aalst
Country [28] 0 0
Canada
State/province [28] 0 0
Montréal
Country [29] 0 0
Canada
State/province [29] 0 0
Ste-Foy
Country [30] 0 0
Denmark
State/province [30] 0 0
Aarhus
Country [31] 0 0
France
State/province [31] 0 0
Caen
Country [32] 0 0
France
State/province [32] 0 0
Nantes
Country [33] 0 0
France
State/province [33] 0 0
Paris
Country [34] 0 0
France
State/province [34] 0 0
Saint-Priest-en-Jarez
Country [35] 0 0
Germany
State/province [35] 0 0
Bochum
Country [36] 0 0
Germany
State/province [36] 0 0
Lübeck
Country [37] 0 0
Hong Kong
State/province [37] 0 0
Aberdeen
Country [38] 0 0
Hong Kong
State/province [38] 0 0
Hong Kong
Country [39] 0 0
Ireland
State/province [39] 0 0
Waterford
Country [40] 0 0
Italy
State/province [40] 0 0
Catanzaro
Country [41] 0 0
Italy
State/province [41] 0 0
Naples
Country [42] 0 0
Italy
State/province [42] 0 0
Negrar
Country [43] 0 0
Italy
State/province [43] 0 0
Verona
Country [44] 0 0
Netherlands
State/province [44] 0 0
Amsterdam
Country [45] 0 0
Netherlands
State/province [45] 0 0
Leiden
Country [46] 0 0
Netherlands
State/province [46] 0 0
Utrecht
Country [47] 0 0
Spain
State/province [47] 0 0
Barcelona
Country [48] 0 0
Spain
State/province [48] 0 0
Las Palmas
Country [49] 0 0
Spain
State/province [49] 0 0
Málaga
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Belfast
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Clydebank
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Dundee
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Edinburgh
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Manchester
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Sheffield
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Gaertner
Address 0 0
Boston Scientific Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03579641