Attain Stability™ Quad Clinical Study | NCT03099655

Label	Type	Description	Intervention Names
Attain Stability Quad Lead	Experimental	Attain Stability Quad Lead (Model 4798) - Single arm study.	Device: Attain Stability Quad Left Ventricular Pacing Lead

Name	Type	Description	Arm Group Labels	Other Names
Attain Stability Quad Left Ventricular Pacing Lead	Device	cardiac stimulation	Attain Stability Quad Lead

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lead Complication-free Rate at 6 Months	Subjects free of Model 4798 lead-related complications at 6 months post-implant -Model 4798 lead will be considered safe if the probability of subjects free from Attain Stability Quad lead-related complications at 6-months post implant is greater than 87% (i.e. the one-sided 97.5% lower confidence bound must be greater than 87%). Complications were defined in the protocol as, "An adverse event that includes the following is considered a complication: Results in death, Involves any termination of significant device function, or Requires an invasive intervention". Relationship of complication to the Attain Stability Quad lead was determined by an independent Clinical Events Committee.	Implant to 6 months post-implant
Proportion (Reported as a Percent) of Subjects With at Least One Vector Having PCT ≤2.5 V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS)	The Model 4798 LV lead has sixteen (16) programmable pacing vectors. The endpoint for the primary efficacy objective is whether or not there is at least one Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 2.5V. -Model 4798 lead will be considered effective if the proportion of subjects with at least one Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 2.5V at 0.5 ms pulse width (with absence of Phrenic Nerve Stimulation at 5.0 V) at 6 months post-implant is greater than 80%.	6 months post-implant
Proportion (Reported as a Percent) of Subjects With at Least One Extra Vector Having PCT ≤ 4.0V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS)	The co-primary efficacy endpoint is whether or not a second Model 4798 lead configuration has a pacing capture threshold less than or equal to 4V, excluding the pacing vector that is already counted to the primary efficacy. -Model 4798 lead will be considered effective if the proportion of subjects with at least one additional Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 4.0 V at 0.5 ms pulse width (with absence of Phrenic Nerve Stimulation at 5.0 V) at 6 months post-implant is greater than 80%.

Secondary Outcomes

Measure	Description	Time Frame
Implant Success	Number of Attain Stability leads successfully implanted subjects divided by number of subjects undergo Attain Stability lead implant procedure	During procedure
Implant Duration

Eligibility Module

Name	Affiliation	Role
George Crossley III, MD	Vanderbilt University Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Phoenix Cardiovascular Research Group, LLC		Phoenix	Arizona	85006	United States
Sequoia Hospital

ID	Title	Description
FG000	Attain Stability Quad Lead	Attain Stability Quad Lead (Model 4798) - Single arm study. Attain Stability Quad Left Ventricular Pacing Lead: cardiac stimulation

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Jul 25, 2017	Nov 8, 2019

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Lead Complication-free Rate at 6 Months

Subjects free of Model 4798 lead-related complications at 6 months post-implant

-Model 4798 lead will be considered safe if the probability of subjects free from Attain Stability Quad lead-related complications at 6-months post implant is greater than 87% (i.e. the one-sided 97.5% lower confidence bound must be greater than 87%). Complications were defined in the protocol as, "An adverse event that includes the following is considered a complication: Results in death, Involves any termination of significant device function, or Requires an invasive intervention". Relationship of complication to the Attain Stability Quad lead was determined by an independent Clinical Events Committee.

Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.

Posted

Number

97.5% Confidence Interval

Survival Probability (% of subjects)

Implant to 6 months post-implant

ID	Title	Description
OG000	Attain Stability Quad Lead	Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)

Units	Counts
Participants	OG000440

Title

Denominators

Categories

Title	Measurements
	OG00097.59(96.12 to 100)

Primary

Proportion (Reported as a Percent) of Subjects With at Least One Vector Having PCT ≤2.5 V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS)

The Model 4798 LV lead has sixteen (16) programmable pacing vectors. The endpoint for the primary efficacy objective is whether or not there is at least one Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 2.5V.

-Model 4798 lead will be considered effective if the proportion of subjects with at least one Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 2.5V at 0.5 ms pulse width (with absence of Phrenic Nerve Stimulation at 5.0 V) at 6 months post-implant is greater than 80%.

Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.

Posted

Number

97.5% Confidence Interval

Percent of Subjects

6 months post-implant

ID	Title	Description
OG000	Attain Stability Quad Lead	All subjects who are successfully implanted with Model 4798 lead and with valid pacing data collected at 6 months post-implant follow-up visit.

Units	Counts
Participants	OG000

Primary

Proportion (Reported as a Percent) of Subjects With at Least One Extra Vector Having PCT ≤ 4.0V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS)

The co-primary efficacy endpoint is whether or not a second Model 4798 lead configuration has a pacing capture threshold less than or equal to 4V, excluding the pacing vector that is already counted to the primary efficacy.

-Model 4798 lead will be considered effective if the proportion of subjects with at least one additional Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 4.0 V at 0.5 ms pulse width (with absence of Phrenic Nerve Stimulation at 5.0 V) at 6 months post-implant is greater than 80%.

All subjects who are successfully implanted with a Model 4798 lead and with valid pacing data collected 6 months post-implant follow-up visit.

Posted

Number

97.5% Confidence Interval

Percent of Subjects

6 months post-implant

ID	Title	Description
OG000	Attain Stability Quad Lead	Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)

Units	Counts
Participants	OG000

Secondary

Implant Success

Number of Attain Stability leads successfully implanted subjects divided by number of subjects undergo Attain Stability lead implant procedure

Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.

Posted

Number

95% Confidence Interval

Percent of Subjects

During procedure

ID	Title	Description
OG000	Attain Stability Quad Lead	Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)

Units	Counts
Participants	OG000440

Secondary

Implant Duration

Summary statistics including mean and standard deviation will be obtained for total implant procedure time (minutes), fluoroscopy time, and cannulation time for each successful implant procedure.

Subjects with a successfully implanted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.

Posted

Mean

Standard Deviation

Minutes

During procedure

ID	Title	Description
OG000	Attain Stability Quad Lead	All subjects who are successfully implanted with a Model 4798 lead and with valid pacing data collected at 6 months post implant follow-up visit.

Units	Counts
Participants	OG000

Secondary

LV Pacing Capture Threshold (PCT) at 6 Months

Summary statistics including mean and standard deviation will be obtained for PCT (volt) measured at 6-month post implant visit for each successful implanted subject with valid pacing data collected at 6 months post implant follow-up visit.

Subjects with a successfully implanted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.

Posted

Mean

Standard Deviation

Volts

Implant to 6 months post-implant

ID	Title	Description
OG000	Attain Stability Quad Lead	All subjects who are successfully implanted with a Model 4798 lead and with valid pacing data collected at 6 months post implant follow-up visit.

Units	Counts
Participants	OG000

Secondary

LV Impedance at 6 Months

Summary statistics including mean and standard deviation will be obtained for Pacing Impedance (Ohm) measured at 6-month post implant visit for each successful implanted subject

Subjects with a successfully implanted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.

Posted

Mean

Standard Deviation

Ohms

Implant to 6 months

ID	Title	Description
OG000	Attain Stability Quad Lead	All subjects who are successfully implanted with a Model 4798 lead and with valid pacing data collected at 6 months post implant follow-up visit.

Units	Counts
Participants	OG000

Secondary

Post Implant Lead Failure Rate

Number of subjects with a given complication from implant through 6 months (183 days) by total number of subjects undergo Attain Stability implant procedure

Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.

Posted

Number

95% Confidence Interval

Percent of Subjects

Implant to 6 months

ID	Title	Description
OG000	Attain Stability Quad Lead	All subjects who are successfully implanted with a Model 4798 lead.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected440 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected440 at risk
Angina pectoris	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00017 events16 affected440 at risk
Atrial flutter	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected440 at risk
Bradycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Cardiac arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected440 at risk
Cardiac failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00012 events11 affected440 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00021 events18 affected440 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00017 events15 affected440 at risk
Cardiac perforation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Palpitations	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Pericardial effusion	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected440 at risk
Pericarditis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected440 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected440 at risk
Gastrointestinal arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Inner ear disorder	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Retinal artery occlusion	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Femoral hernia incarcerated	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected440 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected440 at risk
Death	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Hernia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Implant site haematoma	General disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected440 at risk
Implant site pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Non-cardiac chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected440 at risk
Sudden cardiac death	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Amyloidosis	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected440 at risk
Diverticulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Gangrene	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Implant site infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected440 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Osteomyelitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00010 events9 affected440 at risk
Pneumonia viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Pyelitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected440 at risk
Septic shock	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected440 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected440 at risk
Cardiac vein perforation	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected440 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Incision site inflammation	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Clostridium test positive	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected440 at risk
International normalised ratio increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
White blood cell count increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected440 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected440 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected440 at risk
Metastases to spinal cord	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Presyncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Seizure	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Spinal cord compression	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected440 at risk
Device connection issue	Product Issues	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Device inappropriate shock delivery	Product Issues	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Device pacing issue	Product Issues	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected440 at risk
Device stimulation issue	Product Issues	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected440 at risk
Lead dislodgement	Product Issues	MedDRA 21.0	Systematic Assessment	EG00012 events12 affected440 at risk
Oversensing	Product Issues	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected440 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG00011 events10 affected440 at risk
End stage renal disease	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Haematuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Nephropathy	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Renal impairment	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected440 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected440 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected440 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected440 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected440 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected440 at risk
Medical device change	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected440 at risk
Dry gangrene	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Femoral artery embolism	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Hypertensive emergency	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected440 at risk
Intermittent claudication	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected440 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected440 at risk

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases