Post-Surgical Enhanced Monitoring for Cardiac Arrhythmias and Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— SEARCH-AF  

Official title:

Post-Surgical Enhanced Monitoring for Cardiac Arrhythmias and Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04145648
• Other study ID #: SEARCH-AF-002
• Status: Recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Cardiac Arrhythmias

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