Evidence map›Paper›PMID 40899260›Full record

ArticleCirculation. Heart failure2025

Atrial Mechanics in Heart Failure With Preserved Ejection Fraction: Effect of a No-Implant Interatrial Shunt.

Michal Laufer-Perl, Nir Flint, Yaron Arbel, Fawaz Alenezi, Veraprapas Kittipibul, Dmitry Yaranov, Tamaz Shaburishvili, Rohit Amin, Marat Fudim

3 registry-linked trialsAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Circulation. Heart failure, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT04583527 phase1completednot on this map

Evaluation of the Safety and Feasibility of a Percutaneously Created Interatrial Shunt to Alleviate Heart Failure Symptoms in Patients With Chronic Heart Failure and Preserved or Mid-Range Left Ventricular Ejection Fraction

TypeinterventionalSponsorAlleviant Medical, Inc.Ran2020 to 2021Enrolled15ConditionsHeart FailureArmsALV1 System
NCT04838353 nacompletednot on this map

Evaluation of the Safety and Effectiveness of a Percutaneously Created Interatrial Shunt to Alleviate Heart Failure Symptoms in Patients With Chronic Heart Failure and Preserved or Mid-Range Left Ventricular Ejection Fraction

TypeinterventionalSponsorAlleviant Medical, Inc.Ran2021 to 2023Enrolled13ConditionsHeart FailureArmsALV1 System
NCT05501652 phase1completednot on this map

Evaluation of the Safety and Efficacy of a Percutaneously Created Interatrial Shunt in Patients With Chronic Heart Failure Without Pulmonary Vascular Disease

TypeinterventionalSponsorAlleviant Medical, Inc.Ran2022 to 2023Enrolled5ConditionsHeart FailureArmsALV1System
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Michal Laufer-PerlTel Aviv Sourasky Medical Center, Affiliated with the Gray School of Medicine, Tel Aviv University, Israel (M.L.-P., N.F., Y.A.).ORCID 0000-0001-9105-2559
Nir FlintTel Aviv Sourasky Medical Center, Affiliated with the Gray School of Medicine, Tel Aviv University, Israel (M.L.-P., N.F., Y.A.).
Yaron ArbelTel Aviv Sourasky Medical Center, Affiliated with the Gray School of Medicine, Tel Aviv University, Israel (M.L.-P., N.F., Y.A.).ORCID 0000-0003-4258-6313
Fawaz AleneziDuke University, Durham, NC (F.A., V.K., M.F.).ORCID 0000-0001-8171-2250
Veraprapas KittipibulDuke University, Durham, NC (F.A., V.K., M.F.).
Dmitry YaranovBaptist Memorial Healthcare, Memphis, TN (D.Y.).
Tamaz ShaburishviliTbilisi Heart and Vascular Clinic, Georgia (T.S.).
Rohit AminAscension Sacred Heart Hospital, Pensacola, FL (R.A.).ORCID 0009-0008-7304-7834
Marat FudimDuke University, Durham, NC (F.A., V.K., M.F.).ORCID 0000-0002-8671-7007

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe atria play an important role in the pathophysiology of heart failure with preserved ejection fraction. Decreased left atrial strain is associated with worse clinical outcomes. The impact of no-implant interatrial shunting on atrial structure and function has not been described.

methodsWe characterized the left atrial (LA) and right atrial strain-pressure relationship at rest and during exercise, before and after creation of a no-implant interatrial shunt. We included patients with New York Heart Association class II, III, or ambulatory IV heart failure with a left ventricular ejection fraction ≥40% and elevated LA wedge pressure during supine ergometry (≥25 mm Hg). Exercise hemodynamics and echocardiographic measurements were analyzed at baseline, 1 month and 6 months (echo only) following transcatheter, transeptal creation of a 7 mm no-implant interatrial shunt.

resultsA total of 33 patients were enrolled/included in the study. At 1 month, LA pressure at rest was significantly reduced from 19.7±7.0 to 17.2±5.0 mm Hg (

conclusionsHemodynamic and strain assessment in patients with heart failure with preserved ejection fraction suggests that a no-implant interatrial shunt can significantly improve the pressure-function relationship of the LA. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT04583527, NCT04838353, and NCT05501652.

Indexed as

Atrial Function, LeftAtrial Function, RightHeart AtriaHeart FailureStroke VolumeVentricular Function, LeftAgedAtrial PressureCardiac CatheterizationFemaleHumansMaleMiddle AgedProspective StudiesTime FactorsTreatment Outcomeatrial pressureheart failurehumans

Identifiers

PMID40899260
PMCPMC12533783

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Registered trials

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.