Evidence map›Paper›PMID 35686479›Full record

Trial reportESC heart failure2022

Safety and efficacy of a wireless pulmonary artery pressure sensor: primary endpoint results of the SIRONA 2 clinical trial.

Faisal Sharif, Stephen Rosenkranz, Jozef Bartunek, Tibor Kempf, Birgit Assmus, Niall G Mahon, Wilfried Mullens

Open access · goldAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESC heart failure, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 4 pooled it
7.1field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 4 syntheses or guidelines pooled it, 44 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 7 institutions in 4 countries.

Faisal SharifDepartment of Cardiology, Galway University Hospital, Saolta Group, CURAM and BioInnovate Ireland, National University of Ireland Galway, Galway, Ireland.
Stephen RosenkranzClinic III for Internal Medicine, University of Cologne Heart Center and Cologne Cardiovascular Research Center (CCRC), Cologne, Germany.
Jozef BartunekCardiovascular Center Aalst, OLV Ziekenhuis Aalst, Aalst, Belgium.
Tibor KempfDepartment of Cardiology and Angiology, Centre for Internal Medicine, Hannover Medical School, Hannover, Germany.
Birgit AssmusDepartment of Cardiology and Angiology, University Hospital Giessen and Marburg GmbH, Giessen, Germany.
Niall G MahonDepartment of Cardiovascular Medicine, Mater University Hospital and University College Dublin, Dublin, Ireland.
Wilfried MullensDepartment of Cardiovascular Medicine, Ziekenhuis Oost Limburg, University Hasselt, Genk, Belgium.
Mater Private Hospital · AUMedizinische Hochschule Hannover · DEOllscoil na Gaillimhe – University of Galway · IEOnze Lieve Vrouwziekenhuis Hospital · BEUniversitätsklinikum Gießen und Marburg · DEUniversity of Cologne · DEZiekenhuis Oost-Limburg · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsImplantable pulmonary artery pressure (PAP) sensors have been shown to reduce heart failure hospitalizations (HFH) in selected patients. The goal of this study was to evaluate the safety and efficacy of a novel wireless PAP monitoring system in patients with heart failure (HF). METHODS AND

resultsThis is a prospective, multi-centre, open-label, single-arm trial evaluating the safety and efficacy of the Cordella™ PA Sensor System including the comprehensive Cordella™ Heart Failure System (CHFS) in patients with New York Heart Association (NYHA) Class III heart failure with a heart failure hospitalization and/or increase of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) within 12 months of enrolment. The primary efficacy endpoint was the accuracy of PA sensor mean PAP measurements, compared with fluid-filled catheter mean PAP measurements obtained by standard right heart catheterization (RHC) at 90 days post-implant, assessed in all patients with a successful implant. The primary safety endpoint was freedom from adverse events associated with use of the Cordella PA Sensor System through 30 days post-implant, assessed in all patients who entered the cath lab for PA sensor implant. The PA sensor was successfully implanted in 70 patients. Equivalence between the PA sensor and RHC for mean pulmonary artery pressures was excellent with measurements confined within the equivalence bounds of -4.0 to 4.0 mmHg (mean PAP: 0.0 to 2.9 mmHg, P = 0.003). The device safety profile was excellent with 98.6% freedom from Device System Related Complications, defined as invasive treatment, device explant or death. There were no pressure sensor failures. Patients' adherence to daily measurement transmissions of PAP and vital signs was 94%.

conclusionsThis trial supports the safety and efficacy of the Cordella PA Sensor System and in conjunction with the CHFS enables comprehensive HF management in NYHA class III heart failure patients.

Indexed as

Heart FailurePulmonary ArteryCardiac CatheterizationHumansMonitoring, PhysiologicProspective StudiesGDMTHeart failurePulmonary artery pressureRemote patient monitoring

Identifiers

PMID35686479
PMCPMC9715805
OpenAlexW4281760574

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.