READ-POAF Pilot Studies Postoperative Atrial Fibrillation After Cardiac Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Catharina Ziekenhuis Eindhoven.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Maastricht University Medical Center
Information provided by (Responsible Party):
Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT01530750
First received: February 8, 2012
Last updated: August 31, 2012
Last verified: August 2012
  Purpose

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.


Condition
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: READ-POAF Pilot Study. The Use of the Reveal XT as Device for Postoperative Atrial Fibrillation Detection After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • atrial fibrillation (AF) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    frequency, frequency distribution, and burden of AF


Secondary Outcome Measures:
  • atrial fibrillation (AF) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    frequency, frequency distribution, burden of AF, AF substrate


Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Post cardiac surgery

Detailed 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.

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

those patients undergoing cardiac surgery.

Criteria

Inclusion Criteria:

  • Undergoing non emergency surgery
  • Sinus rhythm on initial visit

Exclusion Criteria:

  • History of atrial fibrillation
  • Internal pacemaker
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530750

Contacts
Contact: Sander Bramer, MD +31402398680 sander.bramer@cze.nl

Locations
Netherlands
Catharina Hospital Recruiting
Eindhoven, Netherlands
Contact: Bramer       sander.bramer@cze.nl   
Maastricht University Medical Center Not yet recruiting
Maastricht, Netherlands
Contact: Bramer       sander.bramer@cze.nl   
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Maastricht University Medical Center
Investigators
Principal Investigator: Bart van Straten, MD, PhD CZE
Study Director: Sander Bramer, MD CZE
Principal Investigator: Jos Maessen, MD. PhD Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT01530750     History of Changes
Other Study ID Numbers: NL37204.060.11
Study First Received: February 8, 2012
Last Updated: August 31, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Catharina Ziekenhuis Eindhoven:
postoperative atrial fibrillation
internal loop recorder
risk factors
coronary artery bypass surgery

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014