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Influence of Telemonitoring on the Management of LVAD-patients

NCT ID: NCT04613401

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-12-31

Brief Summary

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The current study aims to investigate whether telemedical monitoring in patients with terminal heart failure and an implanted left ventricular assist device (LVAD) has an influence on LVAD-associated complications, hospitalization rates and quality of life. This is a prospective observational study. Patients with terminal heart failure and an implanted LVAD, where the indication for telemonitoring has already been stated by the attending physician are included in the study. Written informed consent is obtained from all patients. The telemedical monitoring is carried out by the West German Center for Applied Telemedicine (WZAT) and includes a standardized telephone interview every 3 days. In addition, all patients are equipped with an INR measuring device, a body scale and a clinical thermometer by WZAT. The data is documented in an electronic case file (medPower®). In the event of abnormalities, the West German Heart and Vascular Center (WHGZ) is contacted, and all necessary measures are initiated.

Detailed Description

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Conditions

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Heart Failure Ventricular Assist Device Telemedicine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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VAD-patients with Telemonitoring

questionnaire (observational study)

Intervention Type OTHER

questionnaire about hospitalisation rates, complications (bleeding, infection, thrombosis), quality of life (Kansas-Score), depression (PHQ8)

Interventions

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questionnaire (observational study)

questionnaire about hospitalisation rates, complications (bleeding, infection, thrombosis), quality of life (Kansas-Score), depression (PHQ8)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age\> 18 years
* Indication for telemedicine
* Permanently implanted left ventricular assist device (VAD)

Exclusion Criteria

* no possibility of telephone contact
* patient does not speak german
* incompliance
* rejection or inability to give consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Essen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Julia Hoffmann

Role: CONTACT

[email protected]
+49 201 723 85587

Facility Contacts

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Julia Hoffmann

Role: primary

[email protected]
+49 201 723 85587

References

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Bundesärztekammer (BÄK) KBK, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF). Nationale VersorgungsLeitlinie Chronische Herzinsuffizienz - Langfassung, 2. Auflage. Version 3. 2017.

Reference Type BACKGROUND

Bundesauswertung zum Erfassungsjahr 2018: Herzunterstützungssysteme/Kunstherzen; Qualitätsindikatoren und Kennzahlen. IQTIG - Institut für Qualitätssicherung und Transparenz im Gesundheitswesen; 2019 .

Reference Type BACKGROUND

Reiss N, Schmidt T, Boeckelmann M, Schulte-Eistrup S, Hoffmann JD, Feldmann C, Schmitto JD. Telemonitoring of left-ventricular assist device patients-current status and future challenges. J Thorac Dis. 2018 Jun;10(Suppl 15):S1794-S1801. doi: 10.21037/jtd.2018.01.158.

Reference Type RESULT
PMID: 30034855 (View on PubMed)

Kimura M, Nawata K, Kinoshita O, Yamauchi H, Hoshino Y, Hatano M, Amiya E, Kashiwa K, Endo M, Kagami Y, Nemoto M, Ono M. Readmissions after continuous flow left ventricular assist device implantation. J Artif Organs. 2017 Dec;20(4):311-317. doi: 10.1007/s10047-017-0975-4. Epub 2017 Jul 27.

Reference Type RESULT
PMID: 28752193 (View on PubMed)

Smedira NG, Hoercher KJ, Lima B, Mountis MM, Starling RC, Thuita L, Schmuhl DM, Blackstone EH. Unplanned hospital readmissions after HeartMate II implantation: frequency, risk factors, and impact on resource use and survival. JACC Heart Fail. 2013 Feb;1(1):31-9. doi: 10.1016/j.jchf.2012.11.001. Epub 2013 Feb 4.

Reference Type RESULT
PMID: 24621797 (View on PubMed)

Reiss N, Wegner KK, Hoffmann JD, Schulte Eistrup S, Boeken U, Morshuis M, Schmidt T. Requirements for a Telemedicine Center to Monitor LVAD Patients. Stud Health Technol Inform. 2019;260:146-153.

Reference Type RESULT
PMID: 31118331 (View on PubMed)

Bohm M, Drexler H, Oswald H, Rybak K, Bosch R, Butter C, Klein G, Gerritse B, Monteiro J, Israel C, Bimmel D, Kaab S, Huegl B, Brachmann J; OptiLink HF Study Investigators. Fluid status telemedicine alerts for heart failure: a randomized controlled trial. Eur Heart J. 2016 Nov 1;37(41):3154-3163. doi: 10.1093/eurheartj/ehw099. Epub 2016 Mar 16.

Reference Type RESULT
PMID: 26984864 (View on PubMed)

Hindricks G, Taborsky M, Glikson M, Heinrich U, Schumacher B, Katz A, Brachmann J, Lewalter T, Goette A, Block M, Kautzner J, Sack S, Husser D, Piorkowski C, Sogaard P; IN-TIME study group*. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet. 2014 Aug 16;384(9943):583-590. doi: 10.1016/S0140-6736(14)61176-4.

Reference Type RESULT
PMID: 25131977 (View on PubMed)

Koehler F, Koehler K, Deckwart O, Prescher S, Wegscheider K, Kirwan BA, Winkler S, Vettorazzi E, Bruch L, Oeff M, Zugck C, Doerr G, Naegele H, Stork S, Butter C, Sechtem U, Angermann C, Gola G, Prondzinsky R, Edelmann F, Spethmann S, Schellong SM, Schulze PC, Bauersachs J, Wellge B, Schoebel C, Tajsic M, Dreger H, Anker SD, Stangl K. Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Lancet. 2018 Sep 22;392(10152):1047-1057. doi: 10.1016/S0140-6736(18)31880-4. Epub 2018 Aug 25.

Reference Type RESULT
PMID: 30153985 (View on PubMed)

Berg T, Tewarie L, Moza A, Zayat R, Autschbach R, Stoppe C, Goetzenich A, Benstoem C. [Requirements for outpatient care after implantation of a ventricular assist device : Views of patients and their relatives]. Herz. 2019 May;44(3):257-264. doi: 10.1007/s00059-017-4636-4. Epub 2017 Oct 27. German.

Reference Type RESULT
PMID: 29079934 (View on PubMed)

Other Identifiers

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20-9312-BO

Identifier Type: -

Identifier Source: org_study_id