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BIOSTREAM.HF HeartInsight

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05761249
Recruitment Status : Recruiting
First Posted : March 9, 2023
Last Update Posted : February 6, 2024
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG

Study Description
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Brief Summary:
The main goal is to learn how HeartInsight is used in clinical routine care. HeartInsight is a heart failure monitoring and notification tool within BIOTRONIK's Home Monitoring System. HeartInsight combines patient data as collected by the implanted devices to alert the attending physicians to impending worsening of heart failure events of the patients. This study will create a sound and seamless documentation of approximately 150 HeartInsight alerts, their processing, subsequent interventions and disease progressions. The data will be analyzed to characterize and quantify the use of HeartInsight in a clinical routine set-up.The patient population consists of heart failure patients with BIOTRONIK CRT-D devices that support HeartInsight.

Condition or disease Intervention/treatment
Heart Failure Other: HeartInsight activation

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices - HeartInsight Substudy
Actual Study Start Date : May 2, 2023
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Intervention Details:
  • Other: HeartInsight activation
    HeartInsight is activated at enrollment. The attending physicians are free on how to integrate HeartInsight in the patient care. Any treatment is based on routine care according to guidleines. Only documentation occurs on how the physicians use HeartInsight and actions taken in response to HeartInsight alerts

Outcome Measures
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Primary Outcome Measures :
  1. Rate of WHF hospitalization after HeartInsight activation [ Time Frame: through study completion, an average of 1.5 years ]
    Calculation of worsening heart failure hospitalization events per patient year during study participation when HeartInsight is active


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HeartFailure patients will be recruited by their primary care clinic based on the in/exclusion criteria.
Criteria

Inclusion Criteria:

  • Patient willing and able to give consent
  • Participation in BIO|STREAM.HF
  • HeartInsight-capable CRT-D device implanted or planned to be implanted
  • Symptomatic heart failure NYHA class II or III within 45 days prior to enrollment
  • HeartInsight score available or planned use of HeartInsight
  • History of worsening of heart failure hospitalization or unscheduled outpatient visit with intravenous diuretic therapy for acute worsening of heart failure
  • Patient is willing and able to utilize BIOTRONIK Home Monitoring via CardioMessenger and has sufficient mobile network coverage

Exclusion Criteria:

  • Patient with permanent atrial fibrillation or 100% atrial pacing
  • Patient is not implanted with an atrial or DX lead or atrial sensing is deactivated
  • History of patient incompliance
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05761249


Contacts
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Contact: Andreas Peth, Dr. +49-30-689051288 heartinsight-stream@biotronik.com

Locations
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Czechia
Fakultní nemocnice Olomouc Recruiting
Olomouc, Czechia
Contact: Marian Fedorco, Dr.         
Nemocnice Ceske Budejovice, a.s. Recruiting
České Budějovice, Czechia
Contact: Alan Bulava, Prof.         
France
CHU de Brest Recruiting
Brest, France
Contact: Jacques Mansourati, Prof.         
Hungary
Semmelweis University Recruiting
Budapest, Hungary
Contact: Bela Merkely, Prof.         
The University of Pécs Recruiting
Pécs, Hungary
Contact: Attila Konyi, Dr.         
Latvia
Pauls Stradins Clinical University Hospital Recruiting
Riga, Latvia
Contact: Andrejs Erglis, Prof.         
Portugal
Hospital de Santa Maria Recruiting
Lisboa, Portugal
Contact: Pedro Marques, Dr.         
Sponsors and Collaborators
Biotronik SE & Co. KG
More Information
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Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT05761249    
Other Study ID Numbers: CR033
First Posted: March 9, 2023    Key Record Dates
Last Update Posted: February 6, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases