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BIOSTREAM.HF HeartInsight

Sponsor
Biotronik SE & Co. KG (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05761249
Collaborator
(none)
100
Enrollment
7
Locations
24
Anticipated Duration (Months)
14.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Other: HeartInsight activation

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices - HeartInsight Substudy
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Rate of WHF hospitalization after HeartInsight activation [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Fakultní nemocnice Olomouc Olomouc Czechia
2 Nemocnice Ceske Budejovice, a.s. České Budějovice Czechia
3 Gottsegen National Cardiovascular Center Budapest Hungary
4 Semmelweis University Budapest Hungary
5 The University of Pécs Pécs Hungary
6 Pauls Stradins Clinical University Hospital Riga Latvia
7 Hospital de Santa Maria Lisboa Portugal

Sponsors and Collaborators

  • Biotronik SE & Co. KG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT05761249
Other Study ID Numbers:
  • CR033
First Posted:
Mar 9, 2023
Last Update Posted:
Mar 9, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Mar 9, 2023