Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

READ-POAF Pilot Studies Postoperative Atrial Fibrillation After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01530750
Recruitment Status : Unknown
Verified August 2012 by Catharina Ziekenhuis Eindhoven.
Recruitment status was:  Recruiting
First Posted : February 10, 2012
Last Update Posted : September 3, 2012
Sponsor:
Collaborator:
Maastricht University Medical Center
Information provided by (Responsible Party):
Catharina Ziekenhuis Eindhoven

Tracking Information
First Submitted Date February 8, 2012
First Posted Date February 10, 2012
Last Update Posted Date September 3, 2012
Study Start Date March 2012
Estimated Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 31, 2012)
atrial fibrillation (AF) [ Time Frame: 3 months ]
frequency, frequency distribution, and burden of AF
Original Primary Outcome Measures
 (submitted: February 9, 2012)
atrial fibrillation (AF) [ Time Frame: 3 months ]
frequency, frequencydistribution, and burden of AF
Change History
Current Secondary Outcome Measures
 (submitted: August 31, 2012)
atrial fibrillation (AF) [ Time Frame: 12 months ]
frequency, frequency distribution, burden of AF, AF substrate
Original Secondary Outcome Measures
 (submitted: February 9, 2012)
atrial fibrillation (AF) [ Time Frame: 12 months ]
frequency, frequencydistribution, and burden of AF
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title READ-POAF Pilot Studies Postoperative Atrial Fibrillation After Cardiac Surgery
Official Title READ-POAF Pilot Study. The Use of the Reveal XT as Device for Postoperative Atrial Fibrillation Detection After Cardiac Surgery
Brief 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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population those patients undergoing cardiac surgery.
Condition Atrial Fibrillation
Intervention Not Provided
Study Groups/Cohorts Post cardiac surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 9, 2012)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2014
Estimated Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Undergoing non emergency surgery
  • Sinus rhythm on initial visit

Exclusion Criteria:

  • History of atrial fibrillation
  • Internal pacemaker
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT01530750
Other Study ID Numbers NL37204.060.11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Catharina Ziekenhuis Eindhoven
Study Sponsor Catharina Ziekenhuis Eindhoven
Collaborators 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
PRS Account Catharina Ziekenhuis Eindhoven
Verification Date August 2012