READ-POAF Pilot Studies Postoperative Atrial Fibrillation After Cardiac Surgery
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| ClinicalTrials.gov Identifier: NCT01530750 |
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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
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| Tracking Information | ||||||||||
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| 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 |
atrial fibrillation (AF) [ Time Frame: 3 months ] frequency, frequency distribution, and burden of AF
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| Original Primary Outcome Measures |
atrial fibrillation (AF) [ Time Frame: 3 months ] frequency, frequencydistribution, and burden of AF
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| Change History | ||||||||||
| Current Secondary Outcome Measures |
atrial fibrillation (AF) [ Time Frame: 12 months ] frequency, frequency distribution, burden of AF, AF substrate
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| Original Secondary Outcome Measures |
atrial fibrillation (AF) [ Time Frame: 12 months ] frequency, frequencydistribution, and burden of AF
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| 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. |
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| 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. |
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| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| 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 | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Unknown status | |||||||||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 |
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| PRS Account | Catharina Ziekenhuis Eindhoven | |||||||||
| Verification Date | August 2012 | |||||||||