NCT04395027

Brief Summary

This is an open-label, randomized, controlled trial of iatrogenic atrial septal defect closure with the an atrial septal occluder versus usual care observation in patients post-mitral valve intervention requiring large bore transspetal access.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

May 6, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2022

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

1.9 years

First QC Date

May 15, 2020

Last Update Submit

December 6, 2022

Conditions

Septal Defect, Atrial

Keywords

mitral valve interventioniatrogenic septal defect

Outcome Measures

Primary Outcomes (1)

  • survival

    Survival at 6 months

    6 month

Secondary Outcomes (3)

  • survival

    1 year

  • Freedom from heart failure hospitalization

    1 year

  • NYHA Functional Class

    1 year

Study Arms (2)

Usual care

NO INTERVENTION

These patients will not have their iatrogenic septal defect closed.

Device

EXPERIMENTAL

These patients will have their iatrogenic septal defect closed after the mitral intervention is completed.

Device: atrial septal defect closure

Interventions

atrial septal defect closureDEVICE

The iatrogenic septal defect will be closed in the usual manner

Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 at the time of informed consent signature.
  • Capable of complying with Protocol requirements, including follow-up.
  • An Informed Consent Form signed by Subject or legal representative.
  • Patient has had successful reduction of mitral regurgitation to at most moderate regurgitation post-mitral-clip.

You may not qualify if:

  • Remaining mitral regurgitation of ≥ moderate-severe
  • Subject unable or unwilling to provide informed consent
  • Concomitant severe aortic valve disease
  • Dialysis
  • Pregnancy or intent to become pregnant
  • Life expectancy \< 1 year
  • Active bleeding
  • Inability to follow up with 6-month timepoint due logistical concerns

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marvin Eng

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Marvin Eng, MD

    Henry Ford Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Staff

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 20, 2020

Study Start

May 6, 2020

Primary Completion

March 22, 2022

Study Completion

March 22, 2022

Last Updated

December 8, 2022

Record last verified: 2022-12

Locations

US(1)