NCT06584370

Brief Summary

We use a tiny catheter through the heart to separate the pericardium with gas. We expect this to improve the safety of the Lariat procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable atrial-fibrillation

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

Study Start

First participant enrolled

May 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
9.1 years until next milestone

First Posted

Study publicly available on registry

September 4, 2024

Completed
Last Updated

September 4, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

April 29, 2015

Last Update Submit

August 30, 2024

Conditions

Atrial FibrillationLeft Atrial Appendage LigationPericardiumEpicardial MappingHeart AtriaCardiac Surgical ProceduresCardiac CatheterizationPneumopericardiumLeft Atrial Appendage Occlusion

Outcome Measures

Primary Outcomes (1)

  • Successful subxiphoid needle access without myocardial injury

    Immediate

Study Arms (1)

Pericardial insufflation with CO2

EXPERIMENTAL

Intentional transatrial introduction of a microcatheter to insufflate the pericardium with carbon dioxide, to separate the walls of the pericardium

Procedure: Pericardial insufflation with carbon dioxide through a transatrial microcatheter

Interventions

Pericardial insufflation with carbon dioxide through a transatrial microcatheterPROCEDURE

Separate the walls of the pericardium by insufflating the pericardial space with carbon dioide.

Pericardial insufflation with CO2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 21 years

You may not qualify if:

  • Does not consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (2)

  • Cohn WE, Winkler JA, Tuzun E, Hjelle A, Bassett K, Ahmad A, Frazier OH. Contrast pericardiography facilitates intrapericardial navigation under fluoroscopy. Ann Thorac Surg. 2010 Nov;90(5):1537-40. doi: 10.1016/j.athoracsur.2010.06.025.

    PMID: 20971258BACKGROUND

  • Rogers T, Ratnayaka K, Schenke WH, Faranesh AZ, Mazal JR, O'Neill WW, Greenbaum AB, Lederman RJ. Intentional right atrial exit for microcatheter infusion of pericardial carbon dioxide or iodinated contrast to facilitate sub-xiphoid access. Catheter Cardiovasc Interv. 2015 Aug;86(2):E111-8. doi: 10.1002/ccd.25698. Epub 2014 Oct 28.

    PMID: 25315516RESULT

MeSH Terms

Conditions

Atrial FibrillationPneumopericardium

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director, Structural Heart Disease Program

Study Record Dates

First Submitted

April 29, 2015

First Posted

September 4, 2024

Study Start

May 1, 2014

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

September 4, 2024

Record last verified: 2024-08

Locations

US(1)