Pulmonary Artery Sensor System Pressure Monitoring to Improve Heart Failure (HF) Outcomes
NCT ID: NCT04398654
Last Updated: 2024-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
554 participants
INTERVENTIONAL
2020-10-02
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Wireless, Intermittent Monitoring of Right Heart Pressures in HF
NCT01162707
Feasibility of Novel Clinical Trial Infrastructure, Design and Technology for Early Phase Studies in Patients With Pulmonary Hypertension (FIT-PH)
NCT04078243
Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices
NCT01691586
Physiological Signals, Activity and Posture for Surface Mounted Insertable Cardiac Monitor in Heart Failure Study
NCT04112576
Deployment of American Heart Association Heart Failure Protocols and Content Within the Intel® Health Guide System
NCT01275846
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Group
Monitoring and therapy adjustment within the scope of the basic care described in the clinical trial plan.
No interventions assigned to this group
Intervention Group
As in control group. In addition, in the intervention arm the CardioMEMSTM HF sensor implanted.
CardioMEMSTM HF sensor - pulmonary artery pressure measurement
CardioMEMSTM HF sensor implantation to meassure pulmonary artery pressure. Evaluation of the pressure curves by telemetric transmission and coordination of necessary adjustments of the therapy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CardioMEMSTM HF sensor - pulmonary artery pressure measurement
CardioMEMSTM HF sensor implantation to meassure pulmonary artery pressure. Evaluation of the pressure curves by telemetric transmission and coordination of necessary adjustments of the therapy.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. ≥≥ 18 years of age.
3. Predominant symptoms in NYHA Stage III in the 30-day period prior to consent to the study.
4. Objectified HF diagnosis for more than three months.
5. Hospitalisation within 12 months prior to inclusion due to deterioration of HF symptoms.
6. Able to tolerate dual antiplatelet therapy or anticoagulation therapy for one month after sensor implantation
7. Patients with reduced left ventricular ejection fraction (LVEF) ≤40% (diagnosed within 6 months prior to inclusion) must be treated with guideline-compliant HF pharmacotherapy; if one class of guideline-compliant medication is not tolerated, appropriate documentation must be supplied; patients must receive and tolerate at least one class of guideline-compliant medication; if no guideline-compliant medication is tolerated at all, the patient may not participate in the study.
8. In patients with preserved LVEF (\>40%; diagnosed within 6 months prior to inclu-sion) comorbidities must be treated in accordance with guideline-compliant medi-cation.
9. Chest circumference (measured at axillary level) of less than 165 cm if BMI \>35 kg/m2.
10. Willing and mentally and physically able to meet the requirements for follow-up and long-term basic care (this includes the long-term willingness of the patient, and of their relatives where relevant, to participate in PA pressure-based monitor-ing).
11. Appropriate domestic situation, defined as being accessible by telephone (via fixed or mobile network) .
12. For the intervention group: Implantation is only performed if the diameter of the pulmonary artery branch intended for implantation is ≥7 mm (assessment will be made during the right heart catheterization)
Exclusion Criteria
2. Severe cardiovascular event (e.g. myocardial infarction, open heart surgery, stroke, CRT implantation) in the 2 months prior to admission
3. Therapy-refractory heart failure in ACC/AHA stage D or new therapies that have taken place or are planned in the next 12 months (e.g. implantation of a left ven-tricular assist system / transplantation)
4. Active infection.
5. History of recurrent (\>1 episode) pulmonary embolism and/or deep vein throm-bosis.
6. Continuous or intermittent chronic inotropic therapy.
7. Estimated glomerular filtration rate (eGFR) \<25 ml/min
8. Life expectancy (according to the study physician's assessment) \<12 months.
9. Severe, unrepaired congenital heart defect that would prevent implantation of the sensor.
10. Severe valve vitium with planned intervention in the next 3 months
11. Presence of a mechanical right heart valve.
12. Mental disorder that presumably (in the opinion of the study physician) has a negative impact on patient compliance or consent.
13. Failure of the coordinating physician to approve if the patient is enrolled in an HF disease management program or comparable case management program.
14. Women of childbearing age with a positive pregnancy test at the time of inclusion
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IHF GmbH - Institut für Herzinfarktforschung
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stefan Störk, MD
Role: PRINCIPAL_INVESTIGATOR
Wuerzburg University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SLK-Kliniken GmbH - Klinikum am Plattenwald
Bad Friedrichshall, , Germany
Kerckhoff-Klinik Forschungs GmbH
Bad Nauheim, , Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, , Germany
BG Unfallkrankenhaus Berlin
Berlin, , Germany
Charité Universitätsmedizin (Campus Mitte, Campus Benjamin Franklin)
Berlin, , Germany
Deutsches Herzzentrum Berlin
Berlin, , Germany
Praxis am Spreebogen
Berlin, , Germany
Sana Klinikum Lichtenberg
Berlin, , Germany
Klinikum Bielefeld
Bielefeld, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Klinikum Coburg
Coburg, , Germany
St. Vinzenz Hospital
Cologne, , Germany
St Johannes Hospital Dortmund
Dortmund, , Germany
Praxisklinik Herz und Gefäße
Dresden, , Germany
St. Georg Klinikum
Eisenach, , Germany
Helios Klinikum Erfurt
Erfurt, , Germany
St. Elisabeth Krankenhaus, Contilia Herz- und Gefäßzentrum
Essen, , Germany
Universitätsklinikum Essen
Essen, , Germany
Universitätsklinikum Frankfurt
Frankfurt, , Germany
Universitätsklinikum Gießen
Giessen, , Germany
Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Westpfalz Klinikum
Kaiserslautern, , Germany
Klinikum Karlsburg
Karlsburg, , Germany
Leipzig Heart Institute GmbH
Leipzig, , Germany
Cardio Centrum Ludwigsburg-Bietigheim
Ludwigsburg, , Germany
Klinikum Oldenburg
Oldenburg, , Germany
Klinikum Vest
Recklinghausen, , Germany
Cardio Consil Rostock
Rostock, , Germany
Krankenhaus der Barmherzigen Brüder
Trier, , Germany
Schwarzwald-Baar Klinikum
Villingen-Schwenningen, , Germany
Rems-Murr Klinikum
Winnenden, , Germany
Deutsches Zentrum für Herzinsuffizienz (DZHI)
Würzburg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Thomas Dengler, Prof Dr med
Role: primary
Andreas Rieth, Dr med
Role: primary
Hendrik Fox, Dr med
Role: primary
Sebastian Winkler, Dr med
Role: primary
David Leistner, Prof Dr med
Role: primary
Felix Schönrath, Dr med
Role: primary
Florian Krackhardt, Dr med
Role: primary
Fabian Knebel, Prof Dr med
Role: primary
Christoph Stellbrink, Prof Dr med
Role: primary
Christian Zachoval, Dr med
Role: primary
Steffen Schnupp, Dr med
Role: primary
Stefan Winter, Dr med
Role: primary
Helge Möllmann, Prof Dr med
Role: primary
Stefan Spitzer, Prof Dr med
Role: primary
Marcus Jahnecke, Dr med
Role: primary
Alexander Lauten, Prof Dr med
Role: primary
Oliver Bruder, Dr med
Role: primary
Peter Lüdike, Dr med
Role: primary
Stephan Fichtlscherer, Prof Dr med
Role: primary
Birgit Aßmus, Prof Dr med
Role: primary
Christina Magnussen, Dr med
Role: primary
Tibor Kempf, Prof Dr med
Role: primary
Burghard Schuhmacher, Prof Dr med
Role: primary
Basil Alkhlout, Dr med
Role: primary
Gerhard Hindricks, Prof Dr med
Role: primary
Ralph Bosch, Dr med
Role: primary
Lea Seidlmayer, Dr med
Role: primary
Frank Weidemann, Prof Dr med
Role: primary
Jens Placke, Dr med
Role: primary
Neriman Osman, Dr med
Role: primary
Werner Jung, Prof Dr med
Role: primary
Michael Sailer, Dr med
Role: primary
Stefan Störk, Prof Dr med
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Stork S, Bernhardt A, Bohm M, Brachmann J, Dagres N, Frantz S, Hindricks G, Kohler F, Zeymer U, Rosenkranz S, Angermann C, Assmus B. Pulmonary artery sensor system pressure monitoring to improve heart failure outcomes (PASSPORT-HF): rationale and design of the PASSPORT-HF multicenter randomized clinical trial. Clin Res Cardiol. 2022 Nov;111(11):1245-1255. doi: 10.1007/s00392-022-01987-3. Epub 2022 Mar 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PASSPORT-HF
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.