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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04145648
Other study ID # SEARCH-AF-002
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 30, 2017
Est. completion date December 2020

Study information

Verified date October 2019
Source St. Michael's Hospital, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of SEARCH-AF is to evaluate a novel diagnostic tool for detecting POAF/AFL in cardiac surgical subjects during the early, sub-acute post-operative period.


Recruitment information / eligibility

Status Recruiting
Enrollment 396
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Male or female age =18 years.

2. Isolated CABG or valve replacement/repair +/- CABG performed at the index surgical procedure.

3. At elevated risk of stroke and for having POAF/AFL, defined as having a CHA2DS2-VASC score of =4 or =2 with at least 1 of the following risk factors for developing POAF/AFL:

(i) Chronic obstructive pulmonary disease. (ii) Sleep apnea [34]. (iii) Impaired renal function (defined as creatinine clearance <60 ml/min/1.73m2).

(iv) Echocardiographic evidence of at least mild left atrial enlargement (defined as =41 mm on M-mode, =59 ml or =29 mL/m2 on biplane volume assessment [35] from an echocardiogram performed within 12 months of study enrollment).

(i) Elevated body mass index (defined as BMI =30). (ii) Combined surgery (CABG + valve repair/replacement).

4. Able to provide written informed consent.

Exclusion Criteria:

1. Atrial fibrillation or flutter at the time of randomization.

2. Known previous history of AF/AFL, diagnosed pre-operatively (note: documentation of a history of AF/AFL without accompanying rhythm proof will suffice).

3. Documentation of continuous AF/AFL for =24 hours during the in-hospital stay for the index cardiac surgery.

4. Subjects who, at the discretion of the treating cardiac surgery team, would be treated and discharged with oral anticoagulation due to POAF/AFL.

5. Mechanical valve replacement.

6. Current or anticipated treatment with oral anticoagulation for indications other than AF/AFL.

7. Hospitalization for =10 days (for the index cardiac surgery, with day #0 being the day of surgery).

8. Planned discharge from hospital with a type IC or III anti-arrhythmic drug.

9. Having received >5 grams of IV and/or oral amiodarone during hospitalization for the index cardiac surgical procedure.

10. Women of childbearing potential (WOCBP) (please refer to section 4.3 for definition).

11. History of percutaneous or surgical left atrial ablation for AF.

12. Presence of a cardiac implantable electronic device with a functioning atrial lead (pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization device).

13. Presence of an implantable loop recorder.

14. History of left atrial appendage ligation, removal, or occlusion.

15. Subjects with known allergies or hypersensitivities to adhesives or hydrogel.

16. Inability to provide written informed consent.

17. Current or anticipated participation in another randomized controlled trial in which the interventional drug or device is known to affect the incidence of the primary or secondary outcomes of this study.

Study Design


Intervention

Device:
a wearable adhesive cardiac monitoring device
A wearable adhesive cardiac monitoring device that provides continuous cardiac rhythm monitoring

Locations

Country Name City State
Canada Foothills Medical Centre Calgary Alberta
Canada Mazankowski Alberta Heart Institute Edmonton Alberta
Canada Kingston General Hospital Kingston Ontario
Canada Laval Hospital Laval Quebec
Canada Southlake Regional Health Centre Newmarket Ontario
Canada University of Ottawa Heart Institute Ottawa Ontario
Canada Saint John Regional Hospital St. John's Newfoundland and Labrador
Canada St. Michael's Hospital Toronto Ontario
Canada University Health Network Toronto Ontario
Canada St. Boniface General Hospital Winnipeg Manitoba

Sponsors (3)

Lead Sponsor Collaborator
St. Michael's Hospital, Toronto Southlake Regional Health Centre, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of AF/AFL detection The primary endpoint of this trial is documentation of AF/AFL, defined as a cumulative AF/AFL duration of =6 minutes or documentation of AF/AFL by a 12-lead ECG within 30 days after randomization. Clinical endpoints will be adjudicated by an independent clinical events committee. Visit #1 (31-90 days after discharge)
Secondary AF/AFL lasting for =24 hours Within 30 days after randomization
Secondary AF/AFL lasting for =24 hours 6±1 months after surgery
Secondary Cumulative AF/AFL burden during 14-day monitoring period ((recorded by the wearable adhesive cardiac monitoring device) 6±1 months after surgery
Secondary Proportion of subjects who are prescribed with oral anticoagulation 45 days after discharge
Secondary Proportion of subjects who are prescribed with oral anticoagulation 6±1 months after surgery
Secondary Proportion of subjects who are prescribed with oral anticoagulation 9±1 months after discharge
Secondary Number of days during which the wearable adhesive cardiac rhythm monitor sensor was worn 6±1 months after surgery
Secondary Reasons for premature removal of the wearable adhesive cardiac rhythm monitor 6±1 months after surgery
Secondary Incidence of adverse events related to use of the wearable adhesive cardiac rhythm monitor 6±1 months after surgery
Secondary Performance of non-protocol mandated Holter monitoring and/or event recorders during the 30-day period after randomization 6±1 months after surgery
Secondary All-cause death Within 31 days after discharge
Secondary Myocardial Infarction Within 31 days after discharge
Secondary Ischemic Stroke Within 31 days after discharge
Secondary Non-CNS Systemic Embolism Within 31 days after discharge
Secondary Proportion of subjects who experienced major bleeding events Within45 days after discharge
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