READ-POAF Pilot Studies Postoperative Atrial Fibrillation After Cardiac Surgery

Atrial Fibrillation Clinical Trial

Official title:

READ-POAF Pilot Study. The Use of the Reveal XT as Device for Postoperative Atrial Fibrillation Detection After Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01530750
• Other study ID #: NL37204.060.11
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2012
• Last updated: August 31, 2012
• Start date: March 2012
• Est. completion date: February 2014

Study information

• Verified date: August 2012
• Source: Catharina Ziekenhuis Eindhoven
• Contact: Sander Bramer, MD
• Phone: +31402398680
• Email: sander.bramer[@]cze.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

Postoperative atrial fibrillation after coronary artery bypass grafting will be monitored up to 1 year after the procedure by implanting a Reveal XT internal loop recorder two weeks before the surgery. Frequency, burden, and possible risk factors will be described.

During the operation direct contact epicardial mapping will be performed and tissue samples will be collected to identify an electrophysiological and a structural substrate for development of AF.

Description:

Background of the study:

Postoperative atrial fibrillation (POAF) after cardiac surgery is a common (1 in 4) complication and associated with morbidity and mortality. Not all episodes of AF are noticed and detected, especially after discharge. several studies have shown high mortality in POAF patients, suggesting a progression in AF frequency.

Objective of the study:

To investigate the real incidence and burden of POAF. Afterwards a risk stratification of POAF is made. To identify a structural and electrophysiological substrate for the development of POAF and new onset AF during follow up.

Study design:

140 patients will receive a Reveal device. After 3 and 12 months data will be subtracted from the device. 100 of these patient will undergo additional mapping and tissue biopsies during operation.

Study population:

All patients undergoing cardiac surgery without a history of AF and without a pacemaker will be invited to participate in the study.

Primary study parameters/outcome of the study:

Incidence of POAF until 3 months after CABG.

Secondary study parameters/outcome of the study:

Incidence of POAF until 12 months after CABG. Determine risk factors for early and late POAF. Detect pre-operative (unnoticed) episodes of AF.

Determine a substrate for development of AF.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

There is a small risk of minor complications (hemorrhage and infection of the pocket).The device can be explanted easily if necessary. Ther is a burden of the im- and explantation of the device (local anesthesia, approx. 20 minutes). Patient will have to visit the out-hospital clinic twice.

The operation will be prolonged by 30 minutes due to mapping.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

• Undergoing non emergency surgery

• Sinus rhythm on initial visit

Exclusion Criteria:

• History of atrial fibrillation

• Internal pacemaker

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Netherlands	Catharina Hospital	Eindhoven
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven	Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	atrial fibrillation (AF)	frequency, frequency distribution, and burden of AF	3 months	No
Secondary	atrial fibrillation (AF)	frequency, frequency distribution, burden of AF, AF substrate	12 months	No