Proper Extent of Maze Intercaval Lesion

Atrial Fibrillation Clinical Trial

— Maze  

Official title:

Proper Extent of Maze Intercaval Lesion

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03091205
• Other study ID #: 017-048
• Status: Withdrawn
• Start date: April 15, 2018
• Est. completion date: April 15, 2019

Study information

• Verified date: May 2018
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It's hypothesized that a mean and range distance from the cavo-atrial junction to the area where there is complete loss of conductive tissue can be measured to better inform surgeons performing the Cox-Maze procedure. A patient scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible could be entered into the study if they meet the inclusion/exclusion requirements.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years male or female

• Scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible

• Subjects willing and able to provide written informed consent

Exclusion Criteria:

• Subjects receiving surgery with non-sternotomy access

• Presence of or history of transvenous pacing leads

• Subjects receiving a re-do cardiac surgery

• Subjects with a history of pericarditis

• Subjects who are in atrial fibrillation or atrial flutter and cannot be converted out of it.

• Any medical condition or finding for which the Investigator used medical discretion to determine the subject should be excluded

• Subject is currently participating in another clinical trial.

• Subject is unable to provide written informed consent.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United States	The Heart Hospital Baylor Plano	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance until complete loss of conductive tissue	To measure the mean and range distance from the cavo-atrial junction to the area where there is complete loss of conductive tissue.	6 Months