ArticleFrontiers in cardiovascular medicine2022
Patent foramen ovale occlusion with the Cocoon PFO Occluder. The PROS-IT collaborative project.
Article in Frontiers in cardiovascular medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07380490 (Randomised Controlled Trial Comparing the Safety and EfficAcy of the Cocoon PFO Occluder Versus Amplatzer PFO ClosurE Device for Percutaneous Closure of Patent Foramen Ovale in Patients With a History of Stroke or Transient Ischemic Attack A Non-Profit, Single-blind, Investigator Driven Trial), which is not on this map. Cited by 3 papers.
What it found
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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.
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.
Randomised Controlled Trial Comparing the Safety and EfficAcy of the Cocoon PFO Occluder Versus Amplatzer PFO ClosurE Device for Percutaneous Closure of Patent Foramen Ovale in Patients With a History of Stroke or Transient Ischemic Attack A Non-Profit, Single-blind, Investigator Driven Trial
Who cites it
3 citing papers in PubMed, 3 citations in OpenAlex.
- Transcatheter closure of interatrial communication using the Cocoon occluder in patients with confirmed nickel hypersensitivity: a long-term observational study.Postepy w kardiologii interwencyjnej = Advances in interventional cardiology · 2026Article
- Arrhythmias Following Patent Foramen Ovale Closure: An Unsolved Enigma.Life (Basel, Switzerland) · 2024Review
- The RISE Study: Retrospective Registry for the International Safety and Efficacy Results of Patent Foramen Ovale Closure with Figulla Flex Il PFO and UNI Occluders.Journal of clinical medicine · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors at 14 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: The Cocoon patent foramen ovale (PFO) Occluder is a new generation nitinol alloy double-disk device coated with nanoplatinum, likely useful in patients with nickel hypersensitivity. Early results and mid-term outcomes of this device in percutaneous PFO closure are missing. Aims: To assess the preliminary efficacy and safety profile of PFO closure with Cocoon device in an Italian multi-center registry. Methods: This is a prospective registry of 189 consecutive adult patients treated with the Cocoon PFO Occluder at 15 Italian centers from May 2017 till May 2020. Patients were followed up for 2 years. Results: Closure of the PFO with Cocoon Occluder was carried out successfully in all patients, with complete closure without residual shunt in 94.7% of the patients and minimal shunt in 5.3%. Except from a case of paroxysmal supraventricular tachycardia and a major vascular bleeding, no procedural and in-hospital device-related complications occurred. No patient developed cardiac erosions, allergic reactions to nickel, or any other major complications during the follow-up. During the follow-up period, 2 cases of new-onset atrial fibrillation occurred within thirty-day. Conclusions: Percutaneous closure of PFO with Cocoon Occluder provided satisfactory procedural and mid-term clinical follow-up results in a real-world registry.
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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.