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Clinical trial No longer in our active list Observational Ages 18 and up

Observing heart failure patients with BIOTRONIK CRT devices

Official title: Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices

Run by Biotronik SE & Co. KG · NCT03366545 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study looks at how well cardiac resynchronization therapy (CRT) works for heart failure patients by tracking their progress with new or upgraded devices over time.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment3000 (estimated)
SponsorBiotronik SE & Co. KG
Industry-sponsored
Locations121 sites (Canberra and 120 other locations)
Trial IDNCT03366545 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include heart failure patients who are undergoing a planned de novo implantation or upgrade to a CRT system and are willing to participate in remote monitoring.

Probably not a fit

Patients who have contraindications for CRT, are under 18 years old, or are already implanted with a CRT system may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This registry aims to assess the outcomes and efficacy of cardiac resynchronization therapy (CRT) in heart failure patients through long-term data collection in a real-life clinical setting. It focuses on understanding patient status to identify predictors for heart failure events and areas for improvement in CRT device settings. The study involves monitoring patients who are newly implanted with or upgraded to a CRT system, utilizing remote monitoring technology for data collection.

Why it matters

Potential benefit: If successful, this study could enhance the management and treatment outcomes for heart failure patients receiving CRT.

How similar studies have gone: Other studies have shown success with similar observational approaches in assessing CRT outcomes, indicating potential for valuable insights.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Planned de novo implantation of or upgrade to a CRT system for treatment according to the intended use
* Patient is able to understand the nature of the registry and has provided written informed consent
* Patient is willing and able to use the CardioMessenger and accepts the Home Monitoring concept
* Remote monitoring using the Home Monitoring® platform is planned for the patient

Exclusion Criteria:

* Standard contraindication for CRT
* Already or previously implanted with CRT system
* • Age \< 18 years
* Participation in another interventional clinical investigation other than the registry-based trials of BIO\|STREAM.HF
* Pregnant or breastfeeding

Where it's running

  • CHU de Brest
    Brest, France     Recruiting
  • Le Centre Hospitalier Universitaire de CAEN
    Caen, France     Recruiting
  • Hôpital Privé / Institute Jaques Cartier
    Massy, France     Recruiting
  • Clinique les Fontaines
    Melun, France     Recruiting
  • CHU Montpellier
    Montpellier, France     Recruiting
  • Hôpital privé du Confluent
    Nantes, France     Recruiting
Show 44 more locations
  • Hopital Pitie-Salpetriere
    Paris, France     Recruiting
  • Centre Hospitalier Mémorial de Saint-Lô
    Saint-Lô, France     Recruiting
  • Centre Hospitalier Universitaire de Saint-Étienne
    Saint-Étienne, France     Recruiting
  • Hôpitaux Universitaires de Strasbourg
    Strasbourg, France     Recruiting
  • Chru de Tours
    Tours, France     Recruiting
  • CH de Valence
    Valence, France     Recruiting
  • Canberra Heart Rhythm Foundation
    Canberra, Australia     Terminated
  • The Canberra Hospital
    Canberra, Australia     Terminated
  • Lyell McEwin Hospital
    Elizabeth Vale, Australia     Terminated
  • Liverpool Hospital
    Liverpool, Australia     Terminated
  • Sydney Adventist Hospital
    Sydney, Australia     Completed
  • Westmead Hospital
    Westmead, Australia     Terminated
  • Westmead Private Hosptial
    Westmead, Australia     Terminated
  • Kepler Universitätsklinikum
    Linz, Austria     Terminated
  • Universitätsklinikum St. Pölten
    St. Polten, Austria     Terminated
  • Medizinische Universität Wien
    Vienna, Austria     Terminated
  • Imelda Ziekenhuis
    Bonheiden, Belgium     Terminated
  • UZ Brussel
    Brussels, Belgium     Terminated
  • CHR de la Citadelle - Liège
    Liège, Belgium     Terminated
  • Fakultní nemocnice Olomouc
    Olomouc, Czechia     Active not recruiting
  • Institute for Clinical and Experimental Medicine (IKEM)
    Praha, Czechia     Active not recruiting
  • Nemocnice České Budějovice
    České Budějovice, Czechia     Active not recruiting
  • Centre Hospitalier Louis Pasteur
    Chartres, France     Terminated
  • CHU Dupuytren Limoges
    Limoges, France     Withdrawn
  • CH Saint Philibert
    Lomme, France     Active not recruiting
  • Centre Hospitalier Lorient
    Lorient, France     Active not recruiting
  • Hopital de la Croix Rousse
    Lyon, France     Withdrawn
  • Hôpital privé Clairval
    Marseille, France     Terminated
  • Hopital de la Timone (CHU La Timone)
    Marseille, France     Active not recruiting
  • Clinique du Millenaire
    Montpellier, France     Terminated
  • Hôpital Haut Lévêque
    Pessac Cedex, France     Terminated
  • Centre Hospitalier de Périgeux
    Périgueux, France     Terminated
  • Centre Hospitalier de Rangueil
    Toulouse, France     Terminated
  • Clinique Pasteur Toulouse
    Toulouse, France     Terminated
  • Centre Hospitalier Bretagne Atlantique Prosper Chubert
    Vannes, France     Terminated
  • Städtisches Klinikum St.Georg
    Leipzig, Sachsen, Germany     Completed
  • Zentralklinik Bad Berka GmbH
    Bad Berka, Germany     Terminated
  • HDZ Bad Oeynhausen
    Bad Oeynhausen, Germany     Terminated
  • Maria Heimsuchung - Carita-Klinik Pankow
    Berlin, Germany     Active not recruiting
  • Städtisches Klinikum Brandenburg GmbH
    Brandenburg, Germany     Terminated
  • Krankenhaus Buchholz und Winsen AöR
    Buchholz, Germany     Active not recruiting
  • Universitätsklinikum Erlangen
    Erlangen, Germany     Active not recruiting
  • Universitätsklinikum Giessen und Marburg
    Gießen, Germany     Active not recruiting
  • KMG Klinikum Güstrow
    Güstrow, Germany     Terminated

+71 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Heart Failure 1020Biotronik SE & Co. KG 6
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.