Trial Outcomes & Findings for Post-Embolic Rhythm Detection With Implantable Versus External Monitoring (NCT NCT02428140)

NCT ID: NCT02428140

Last Updated: 2024-03-12

Results Overview

Definite AF or highly probable AF (adjudicated new AF lasting ≥2 minutes within 12 months of randomization)

Recruitment status

COMPLETED

Study phase

Target enrollment

300 participants

Primary outcome timeframe

12 months

Results posted on

2024-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	Implanted Loop Recorder long-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months Medtronic Reveal LINQ	External Loop Recorder external event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days Sorin Spiderflash-t
Overall Study STARTED	150	150
Overall Study COMPLETED	150	150
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race/ethnicity data was not collected.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Implanted Loop Recorder n=150 Participants long-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months Medtronic Reveal LINQ	External Loop Recorder n=150 Participants external event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days Sorin Spiderflash-t	Total n=300 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=150 Participants	0 Participants n=150 Participants	0 Participants n=300 Participants
Age, Categorical Between 18 and 65 years	150 Participants n=150 Participants	150 Participants n=150 Participants	300 Participants n=300 Participants
Age, Categorical >=65 years	0 Participants n=150 Participants	0 Participants n=150 Participants	0 Participants n=300 Participants
Age, Continuous	65.5 years n=150 Participants	63.4 years n=150 Participants	64.2 years n=300 Participants
Sex: Female, Male Female	61 Participants n=150 Participants	60 Participants n=150 Participants	121 Participants n=300 Participants
Sex: Female, Male Male	89 Participants n=150 Participants	90 Participants n=150 Participants	179 Participants n=300 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants Race/ethnicity data was not collected.	0 Participants Race/ethnicity data was not collected.	0 Participants Race/ethnicity data was not collected.
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants Race/ethnicity data was not collected.	0 Participants Race/ethnicity data was not collected.	0 Participants Race/ethnicity data was not collected.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants Race/ethnicity data was not collected.	0 Participants Race/ethnicity data was not collected.	0 Participants Race/ethnicity data was not collected.
Region of Enrollment Canada	150 participants n=150 Participants	150 participants n=150 Participants	300 participants n=300 Participants
Hypertension	93 Participants n=150 Participants	94 Participants n=150 Participants	187 Participants n=300 Participants
Previous Stroke	36 Participants n=150 Participants	34 Participants n=150 Participants	70 Participants n=300 Participants

PRIMARY outcome

Timeframe: 12 months

Definite AF or highly probable AF (adjudicated new AF lasting ≥2 minutes within 12 months of randomization)

Outcome measures

Outcome measures
Measure	Implanted Loop Recorder n=150 Participants long-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months Medtronic Reveal LINQ	External Loop Recorder n=150 Participants external event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days Sorin Spiderflash-t
Definite AF or Highly Probable AF	23 Participants	7 Participants

SECONDARY outcome

Timeframe: 12 months

Detection of atrial fibrillation lasting ≥ 2 minutes or death by 12 months.

Outcome measures

Outcome measures
Measure	Implanted Loop Recorder n=150 Participants long-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months Medtronic Reveal LINQ	External Loop Recorder n=150 Participants external event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days Sorin Spiderflash-t
AF Lasting ≥2 Min or Death by 12 Months	26 Participants	10 Participants

SECONDARY outcome

Timeframe: 12 months

Transient ischemic attack.

Outcome measures

Outcome measures
Measure	Implanted Loop Recorder n=150 Participants long-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months Medtronic Reveal LINQ	External Loop Recorder n=150 Participants external event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days Sorin Spiderflash-t
TIA	6 Participants	2 Participants

SECONDARY outcome

Timeframe: 12 months

Recurrent ischemic stroke.

Outcome measures

Outcome measures
Measure	Implanted Loop Recorder n=150 Participants long-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months Medtronic Reveal LINQ	External Loop Recorder n=150 Participants external event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days Sorin Spiderflash-t
Recurrent Stroke	5 Participants	8 Participants

SECONDARY outcome

Timeframe: 12 months

Intracerebral hemorrhage.

Outcome measures

Outcome measures
Measure	Implanted Loop Recorder n=150 Participants long-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months Medtronic Reveal LINQ	External Loop Recorder n=150 Participants external event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days Sorin Spiderflash-t
Hemorrhage	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 months

Participant death.

Outcome measures

Outcome measures
Measure	Implanted Loop Recorder n=150 Participants long-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months Medtronic Reveal LINQ	External Loop Recorder n=150 Participants external event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days Sorin Spiderflash-t
Death	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 12 months

Initiation of oral anticoagulation therapy in patients with definite AF.

Outcome measures

Outcome measures
Measure	Implanted Loop Recorder n=150 Participants long-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months Medtronic Reveal LINQ	External Loop Recorder n=150 Participants external event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days Sorin Spiderflash-t
Oral Anticoagulation Therapy	23 Participants	7 Participants

SECONDARY outcome

Timeframe: 12 months

Patients with ≥1 serious adverse event.

Outcome measures

Outcome measures
Measure	Implanted Loop Recorder n=150 Participants long-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months Medtronic Reveal LINQ	External Loop Recorder n=150 Participants external event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days Sorin Spiderflash-t
≥1 Serious Adverse Event	14 Participants	4 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Outcome measure not performed.

Compliance with assigned therapy (accept ILR, conduct at least 80% of ELR assessments)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Outcome measure not performed.

Costs for all cardiac and non-cardiac investigations related to etiologic workup of index stroke / TIA.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Outcome measure not performed.

Total duration of any detected atrial fibrillation / atrial flutter.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Outcome measure not performed

Association between baseline clinical characteristics (e.g. comorbidities, burden of supraventricular ectopy on Holter, left atrial dimension) and subsequent detection of AF

Outcome measures

Outcome data not reported

Adverse Events

Implanted Loop Recorder

Serious events: 14 serious events

Other events: 0 other events

Deaths: 3 deaths

External Loop Recorder

Serious events: 4 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brian Buck

University of Alberta

Phone: 78024819227

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Implanted Loop Recorder n=150 participants at risk long-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months Medtronic Reveal LINQ	External Loop Recorder n=150 participants at risk external event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days Sorin Spiderflash-t
Infections and infestations Bacterial peritonitis	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Renal and urinary disorders Bladder Neck Obstruction	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Cardiac disorders Cardiac Amyloidosis	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Respiratory, thoracic and mediastinal disorders COPD Exacerbation	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Skin and subcutaneous tissue disorders Device-Related Skin Erosion	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Musculoskeletal and connective tissue disorders Femoral fracture	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Gastrointestinal disorders Gastrointestinal bleeding	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular Carcinoma	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Cardiac disorders High-Grade Symptomatic Atrioventricular Block	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Musculoskeletal and connective tissue disorders Hip Fracture	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Cardiac disorders Myocardial Infarction	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	1.3% 2/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Gastrointestinal disorders Pancolitis	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Musculoskeletal and connective tissue disorders Multiple Trauma	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Musculoskeletal and connective tissue disorders Quadriceps Tendon Rupture	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Nervous system disorders Recrudescence of Stroke Deficits	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Renal and urinary disorders Renal Colic	0.67% 1/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.
Cardiac disorders Symptomatic Sinus Bradycardia	1.3% 2/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.	0.00% 0/150 • 12 months A clinical events committee reviewed all serious adverse events 12 months after study initiation to ensure that neither group had a disproportionate accumulation of adverse events. The study used approved devices therefore nonserious adverse events were not tracked.