Trial Outcomes & Findings for Reveal LINQ for Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT04169529)
NCT ID: NCT04169529
Last Updated: 2024-10-26
Results Overview
Incidence of first COPD event
Recruitment status
COMPLETED
Target enrollment
42 participants
Primary outcome timeframe
from subject randomization until 12 month follow-up
Results posted on
2024-10-26
Participant Flow
Though 42 subjects were enrolled, 2 subjects did not have successful Reveal LINQ insertions. Therefore, 40 subjects started the study.
Participant milestones
| Measure |
Full Cohort
Participants had a successful Reveal LINQ insertion and investigational RAMware download.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One subject was missing baseline respiratory rate measurement
Baseline characteristics by cohort
| Measure |
Full Cohort
n=40 Participants
Participants had a successful Reveal LINQ insertion and investigational RAMware download.
|
|---|---|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 6.6 • n=40 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=40 Participants
|
|
Heart Rate
|
80.5 bpm
STANDARD_DEVIATION 15.3 • n=40 Participants
|
|
Respiratory rate
|
18.2 breaths per minute
STANDARD_DEVIATION 2.7 • n=39 Participants • One subject was missing baseline respiratory rate measurement
|
PRIMARY outcome
Timeframe: from subject randomization until 12 month follow-upIncidence of first COPD event
Outcome measures
| Measure |
Full Cohort
n=40 Participants
Participants had a successful Reveal LINQ insertion and investigational RAMware download.
|
|---|---|
|
COPD Event
|
28 Participants
|
Adverse Events
Full Cohort
Serious events: 27 serious events
Other events: 24 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Full Cohort
n=40 participants at risk
Participants had a successful Reveal LINQ insertion and investigational RAMware download.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
2/40 • Number of events 2 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Cardiac disorders
Acute myocardial infarction
|
5.0%
2/40 • Number of events 2 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Cardiac disorders
Angina pectoris
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Cardiac disorders
Atrial fibrillation
|
12.5%
5/40 • Number of events 8 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Cardiac disorders
Cardiac failure acute
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Cardiac disorders
Cardiac failure congestive
|
5.0%
2/40 • Number of events 2 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Cardiac disorders
Cardiogenic shock
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Cardiac disorders
Coronary artery occlusion
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Cardiac disorders
Coronary artery stenosis
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Cardiac disorders
Pericarditis
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Cardiac disorders
Sinus tachycardia
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Endocrine disorders
Hypothyroidism
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Endocrine disorders
Thyroid mass
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Gastrointestinal disorders
Colitis
|
5.0%
2/40 • Number of events 2 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Gastrointestinal disorders
Umbilical hernia
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
General disorders
Chest pain
|
7.5%
3/40 • Number of events 4 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
General disorders
Death
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
General disorders
Oedema peripheral
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Hepatobiliary disorders
Cholangitis
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
Bacteraemia
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
COVID-19
|
5.0%
2/40 • Number of events 2 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
Cellulitis
|
5.0%
2/40 • Number of events 2 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
Localised infection
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
Medical device site cellulitis
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
Pneumonia
|
12.5%
5/40 • Number of events 8 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
Pneumonia aspiration
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
Sepsis
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
Septic shock
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
Staphylococcal infection
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
2/40 • Number of events 2 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Investigations
Blood lactic acid increased
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Nervous system disorders
Paraesthesia
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Nervous system disorders
Syncope
|
5.0%
2/40 • Number of events 2 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
1/40 • Number of events 2 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
5.0%
2/40 • Number of events 2 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
47.5%
19/40 • Number of events 43 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Vascular disorders
Hypotension
|
2.5%
1/40 • Number of events 2 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Vascular disorders
Intermittent claudication
|
2.5%
1/40 • Number of events 2 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Vascular disorders
Shock
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Vascular disorders
Subclavian artery stenosis
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
Other adverse events
| Measure |
Full Cohort
n=40 participants at risk
Participants had a successful Reveal LINQ insertion and investigational RAMware download.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Cardiac disorders
Sinus arrest
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Cardiac disorders
Ventricular tachycardia
|
5.0%
2/40 • Number of events 2 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
General disorders
Oedema
|
5.0%
2/40 • Number of events 2 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
Acute sinusitis
|
5.0%
2/40 • Number of events 2 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
Bronchitis
|
5.0%
2/40 • Number of events 3 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
COVID-19
|
10.0%
4/40 • Number of events 5 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
Pneumonia
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
Staphylococcal infection
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
45.0%
18/40 • Number of events 39 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.5%
3/40 • Number of events 4 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Vascular disorders
Hypertension
|
2.5%
1/40 • Number of events 2 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
|
Vascular disorders
Orthostatic hypotension
|
2.5%
1/40 • Number of events 1 • The data were collected from informed consent until death or study completion, two years
All serious, LINQ system and procedure, pulmonary, and cardiovascular-related adverse events were collected throughout the study duration. The Endpoint Adjudication Committee reviewed all pulmonary-related AEs to determine COPD events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place