Observing heart failure patients with BIOTRONIK CRT devices

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

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 type: Observational
• Enrollment: 3000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Biotronik SE & Co. KG (Industry-sponsored)
• Locations: 121 sites (Canberra and 120 other locations)
• Trial ID: NCT03366545 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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

Eligibility 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 this trial is running

Canberra and 120 other locations

• 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)
• CHU de Brest — Brest, France (Recruiting)
• Le Centre Hospitalier Universitaire de CAEN — Caen, France (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)
• Hôpital Privé / Institute Jaques Cartier — Massy, France (Recruiting)
• Clinique les Fontaines — Melun, France (Recruiting)
• CHU Montpellier — Montpellier, France (Recruiting)
• Clinique du Millenaire — Montpellier, France (Terminated)
• Hôpital privé du Confluent — Nantes, France (Recruiting)
• Hopital Pitie-Salpetriere — Paris, France (Recruiting)
• Hôpital Haut Lévêque — Pessac Cedex, France (Terminated)
• Centre Hospitalier de Périgeux — Périgueux, France (Terminated)
• 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)
• Centre Hospitalier de Rangueil — Toulouse, France (Terminated)
• Clinique Pasteur Toulouse — Toulouse, France (Terminated)
• Chru de Tours — Tours, France (Recruiting)
• CH de Valence — Valence, France (Recruiting)
• 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)

Study contacts

• Study coordinator: Maria Jung, Dr.

Conditions Heart Failure; cardiac resynchronization therapy; CRT; clinical routine