NCT04780022

Brief Summary

  • Describe the baseline and procedural characteristics of older patients undergoing PFO closure due to cryptogenic embolism.
  • Assess the long-term follow-up of this cohort, focusing on neurological events and their origin, major cardiac outcomes, as well as survival rates and death origin.
  • Seek for predictors of neurological event recurrence after the procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

February 25, 2021

Last Update Submit

February 10, 2022

Conditions

Patent Foramen OvaleIschemic StrokeOlder People

Outcome Measures

Primary Outcomes (8)

  • Rate of stroke

    Through study completion, an average of 1 year

  • Rate of transient ischemic attack

    Through study completion, an average of 1 year

  • Rate of peripheral embolism

    Through study completion, an average of 1 year

  • Rate of deep venous thrombosis

    Through study completion, an average of 1 year

  • Rate of atrial fibrillation

    Through study completion, an average of 1 year

  • Rate of myocardial infarction

    Through study completion, an average of 1 year

  • Rate of bleeding

    Through study completion, an average of 1 year

  • Rate of death

    Through study completion, an average of 1 year

Study Arms (1)

Older patients with cryptogenic embolism and PFO closure

Data (clinical events at last follow-up) on patients older than 60 years who have experienced a previous paradoxical embolism of unknown origin and underwent transcatheter PFO closure will be collected.

Other: Clinical events at last follow-up

Interventions

Clinical events at last follow-upOTHER

Clinical events (stroke, transient ischemic attack, peripheral embolism, deep venous thrombosis, atrial fibrillation, myocardial infarction, bleeding episode, death) at last follow-up

Older patients with cryptogenic embolism and PFO closure

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients older than 60 years who have experienced a previous paradoxical embolism of unknown origin and underwent transcatheter PFO closure.

You may qualify if:

  • Patients older than 60 years who have experienced a previous paradoxical embolism (stroke, transient ischaemic attack or peripheral embolism) of unknown origin and underwent transcatheter PFO closure.

You may not qualify if:

  • PFO closure indication other than paradoxical embolism (example: platypnea orthodeoxia syndrome).
  • Surgical PFO closure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRIUCPQ

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (6)

  • Sondergaard L, Kasner SE, Rhodes JF, Andersen G, Iversen HK, Nielsen-Kudsk JE, Settergren M, Sjostrand C, Roine RO, Hildick-Smith D, Spence JD, Thomassen L; Gore REDUCE Clinical Study Investigators. Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke. N Engl J Med. 2017 Sep 14;377(11):1033-1042. doi: 10.1056/NEJMoa1707404.

    PMID: 28902580BACKGROUND

  • Mas JL, Derumeaux G, Guillon B, Massardier E, Hosseini H, Mechtouff L, Arquizan C, Bejot Y, Vuillier F, Detante O, Guidoux C, Canaple S, Vaduva C, Dequatre-Ponchelle N, Sibon I, Garnier P, Ferrier A, Timsit S, Robinet-Borgomano E, Sablot D, Lacour JC, Zuber M, Favrole P, Pinel JF, Apoil M, Reiner P, Lefebvre C, Guerin P, Piot C, Rossi R, Dubois-Rande JL, Eicher JC, Meneveau N, Lusson JR, Bertrand B, Schleich JM, Godart F, Thambo JB, Leborgne L, Michel P, Pierard L, Turc G, Barthelet M, Charles-Nelson A, Weimar C, Moulin T, Juliard JM, Chatellier G; CLOSE Investigators. Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke. N Engl J Med. 2017 Sep 14;377(11):1011-1021. doi: 10.1056/NEJMoa1705915.

    PMID: 28902593BACKGROUND

  • Saver JL, Carroll JD, Thaler DE, Smalling RW, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke. N Engl J Med. 2017 Sep 14;377(11):1022-1032. doi: 10.1056/NEJMoa1610057.

    PMID: 28902590BACKGROUND

  • Lee PH, Song JK, Kim JS, Heo R, Lee S, Kim DH, Song JM, Kang DH, Kwon SU, Kang DW, Lee D, Kwon HS, Yun SC, Sun BJ, Park JH, Lee JH, Jeong HS, Song HJ, Kim J, Park SJ. Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial. J Am Coll Cardiol. 2018 May 22;71(20):2335-2342. doi: 10.1016/j.jacc.2018.02.046. Epub 2018 Mar 12.

    PMID: 29544871BACKGROUND

  • Wintzer-Wehekind J, Alperi A, Houde C, Cote JM, Del Val D, Cote M, Rodes-Cabau J. Transcatheter closure of patent foramen ovale in patients older than 60 years of age with cryptogenic embolism. Rev Esp Cardiol (Engl Ed). 2020 Mar;73(3):219-224. doi: 10.1016/j.rec.2019.07.003. Epub 2019 Oct 1. English, Spanish.

    PMID: 31585849BACKGROUND

  • Kent DM, Ruthazer R, Weimar C, Mas JL, Serena J, Homma S, Di Angelantonio E, Di Tullio MR, Lutz JS, Elkind MS, Griffith J, Jaigobin C, Mattle HP, Michel P, Mono ML, Nedeltchev K, Papetti F, Thaler DE. An index to identify stroke-related vs incidental patent foramen ovale in cryptogenic stroke. Neurology. 2013 Aug 13;81(7):619-25. doi: 10.1212/WNL.0b013e3182a08d59. Epub 2013 Jul 17.

    PMID: 23864310BACKGROUND

MeSH Terms

Conditions

Foramen Ovale, PatentIschemic Stroke

Condition Hierarchy (Ancestors)

Heart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 3, 2021

Study Start

April 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

CA(1)