Intracardiac CrYoablation for AtrioVentricular Nodal Reen... | NCT01426425

Status Module

Label	Type	Description	Intervention Names
Cryoablation	Experimental	Subjects diagnosed with atrioventricular nodal reentrant tachycardia and treated by cryoablation with Freezor Xtra.	Device: Freezor Xtra Cryoablation Catheter

Name	Type	Description	Arm Group Labels	Other Names
Freezor Xtra Cryoablation Catheter	Device	Freezor® Xtra Cardiac CryoAblation applied for cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia using an endocardial approach.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.	Subjects must have met both of the following acute and chronic conditions to be considered a chronic effectiveness (treatment) success: Acute Success: The inability to induce more than one echo beat by the same pacing maneuvers that induced AVNRT before cryoablation (with drug provocation if required for induction before cryoablation) at the conclusion of the study cryoablation procedure assessment. Chronic Success: Lack of documented recurrence of clinical AVNRT during the 6-month follow-up period after the study cryoablation procedure.	6 months
Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.	Subjects who had at least one safety event during or after their cryoablation procedure or through 6 months of follow-up are considered a primary (chronic) safety failure. A safety event is defined as the occurrence of any adverse event that is adjudicated by the AE Adjudication Committee as being serious and study ablation procedure-related and/or Freezor Xtra Catheter related that: 1) Resulted in death, 2) Resulted in a life-threatening illness or injury, 3) Resulted in permanent impairment of a body function or permanent damage to a body structure, 4) Necessitated significant intervention, such as major surgery or even intravenous medical therapy (e.g., vasopressors), to prevent permanent impairment of a body function or permanent damage to a body structure, or 5) Required in-patient hospitalization or a prolongation of an existing hospital stay.	6 Months

Secondary Outcomes

Measure	Description	Time Frame
Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success.	If there was no documented evidence of AVNRT recurrence in the post-procedure 6-month follow-up period, the subject is counted as a chronic effectiveness success. The AE Adjudication Committee adjudication of AVNRT recurrence is used to classify subjects for this endpoint.

Eligibility Module

Eligibility Criteria

Pre-Electrophysiology Study Inclusion Criteria:

Supraventricular tachycardia (SVT) compatible with atrioventricular nodal reentrant tachycardia (AVNRT), documented by ECG, TTM, Holter or event monitor

Pre-Electrophysiology Study Exclusion Criteria:

History of sustained (≥30 seconds) of ventricular tachycardia
Atrial tachycardia or other arrhythmia that could be confused with AVNRT
Reversible cause of SVT
History of previous AVNRT ablation
Therapy with amiodarone within last 90 days
Unstable angina/myocardial infarction/open heart surgery in past 60 days
New York Heart Association (NYHA) Classification III or IV currently or within the past 90 days
Implantable cardiac rhythm device
Atrioventricular block (first degree (PR interval ≥ 220ms), second degree, or third degree) or left bundle branch block
Stroke or transient ischemic attack within the past 180 days
Life expectancy less than 12 months
Female known to be pregnant
Unable/unwilling to give informed consent
Unable/unwilling to comply with follow-up visits and study requirements
Less than 18 years of age
Active systemic infection
Cryoglobulinemia
Other conditions where the manipulation of the catheter would be unsafe (for example, intracardiac mural thrombus)
Participating in a concurrent clinical study that may confound the results of this study

Post-Electrophysiology Study Inclusion Criteria:

Subject must have one electrophysiology study documented inducible sustained (greater than or equal to 15 seconds) supraventricular tachycardia that is classified as AVNRT.

Post-Electrophysiology Study Exclusion Criteria:

Presence of a second inducible arrhythmia that could be confused with AVNRT during follow-up or will likely result in ablation within the next 6 months
Presence of inducible sustained ventricular tachycardia or fibrillation
Presence of an accessory pathway
Presence of abnormal conduction or refractoriness parameters of the atrioventricular conduction system.
Indication for a pacemaker, defibrillator or cardiac resynchronization therapy (CRT)

Name	Affiliation	Role
Peter Wells, M.D.	Baylor Univ Medical Ctr Dallas, TX.	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Banner Good Samaritan Medical Center		Phoenix	Arizona	85006	United States
Pacific Heart Institute

PubMed Identifier	Type	Citation	Retractions
29044787	Derived	Wells P, Dubuc M, Klein GJ, Dan D, Roux JF, Lockwood E, Sturmer M, Dunbar D, Novak P, Rao A, Peterson BJ, Kueffer F, Ellenbogen KA; ICY-AVNRT Investigators. Intracardiac ablation for atrioventricular nodal reentry tachycardia using a 6 mm distal electrode cryoablation catheter: Prospective, multicenter, North American study (ICY-AVNRT STUDY). J Cardiovasc Electrophysiol. 2018 Jan;29(1):167-176. doi: 10.1111/jce.13367. Epub 2017 Nov 10.

ID	Title	Description
FG000	All Participants	All subjects enrolled into the study.

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

Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.

Subjects must have met both of the following acute and chronic conditions to be considered a chronic effectiveness (treatment) success:

Acute Success: The inability to induce more than one echo beat by the same pacing maneuvers that induced AVNRT before cryoablation (with drug provocation if required for induction before cryoablation) at the conclusion of the study cryoablation procedure assessment.
Chronic Success: Lack of documented recurrence of clinical AVNRT during the 6-month follow-up period after the study cryoablation procedure.

The modified intent-to-treat (mITT) set consists of subjects who signed the ICY-AVNRT consent form and met all Pre-EP and Post-EP study inclusion and no exclusion criteria who had a Freezor Xtra Cardiac Cryoablation Catheter inserted into the vasculature for the purpose of the ICY-AVNRT study.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	mITT Set	The modified intent-to-treat (mITT) set.

Units	Counts
Participants	OG000397

Title

Denominators

Categories

Title	Measurements
Chronic effectiveness success	OG000368
Chronic effectiveness failure	OG00029

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	The following hypothesis was tested at a one-sided 0.025 significance level. Ho: PE ≤ 0.83 Ha: PE > 0.83 Where PE is the probability of a subject achieving chronic effectiveness success at the 6-month follow-up and 0.83 (83%) is the pre-specified performance goal.	Kaplan-Meier log-log 95% CI		<0.0001		Chronic effectiveness prob at 6 months	0.926			2-Sided	95	0.895	0.948			The chronic effectiveness success probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.

Primary

Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.

Subjects who had at least one safety event during or after their cryoablation procedure or through 6 months of follow-up are considered a primary (chronic) safety failure. A safety event is defined as the occurrence of any adverse event that is adjudicated by the AE Adjudication Committee as being serious and study ablation procedure-related and/or Freezor Xtra Catheter related that: 1) Resulted in death, 2) Resulted in a life-threatening illness or injury, 3) Resulted in permanent impairment of a body function or permanent damage to a body structure, 4) Necessitated significant intervention, such as major surgery or even intravenous medical therapy (e.g., vasopressors), to prevent permanent impairment of a body function or permanent damage to a body structure, or 5) Required in-patient hospitalization or a prolongation of an existing hospital stay.

Posted

Count of Participants

Participants

6 Months

ID	Title	Description
OG000	mITT Set	The modified intent-to-treat (mITT) set.

Units	Counts

Secondary

Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success.

If there was no documented evidence of AVNRT recurrence in the post-procedure 6-month follow-up period, the subject is counted as a chronic effectiveness success. The AE Adjudication Committee adjudication of AVNRT recurrence is used to classify subjects for this endpoint.

The 378 mITT subjects who had acute procedural success with cryoablation for the treatment of AVNRT are included in this analysis.

Posted

Count of Participants

Participants

6 Months

ID	Title	Description
OG000	mITT Subjects With Acute Procedural Success	The modified intent-to-treat (mITT) subjects who had acute procedural success with cryoablation for the treatment of AVNRT.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Angina pectoris	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Palpitations	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Gastritis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Device difficult to use	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Non-cardiac chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Bronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Pyelonephritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Incision site haemorrhage	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Arthrofibrosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Retrognathia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Syncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Menometrorrhagia	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Pelvic prolapse	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Arrhythmia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG00012 events9 affected397 at risk
Atrial flutter	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0006 events6 affected397 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Bundle branch block right	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG00011 events11 affected397 at risk
Cardiac flutter	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Junctional ectopic tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Palpitations	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG00055 events43 affected397 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0007 events7 affected397 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG00027 events22 affected397 at risk
Tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0007 events7 affected397 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Laryngocele	Congenital, familial and genetic disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0004 events4 affected397 at risk
Hypothyroidism	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk
Cataract	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Keratitis	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Cheilitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Colitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk
Flatulence	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Gastritis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Toothache	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Adverse drug reaction	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Chest discomfort	General disorders	MedDRA 18.0	Systematic Assessment	EG0008 events6 affected397 at risk
Chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG00019 events18 affected397 at risk
Fatigue	General disorders	MedDRA 18.0	Systematic Assessment	EG0004 events4 affected397 at risk
Gait disturbance	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Malaise	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Non-cardiac chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0004 events4 affected397 at risk
Oedema peripheral	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk
Polyp	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Hypersensitivity	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Acute sinusitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0008 events4 affected397 at risk
Bacterial vaginosis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Breast abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Bronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0009 events9 affected397 at risk
Cellulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Conjunctivitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Furuncle	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk
Herpes zoster	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Hordeolum	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Influenza	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Pharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0005 events5 affected397 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0004 events3 affected397 at risk
Pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk
Respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Sinusitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0006 events5 affected397 at risk
Skin candida	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0009 events7 affected397 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0009 events6 affected397 at risk
Vaginal infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 events1 affected397 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Animal scratch	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0005 events5 affected397 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0005 events5 affected397 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Blood cholesterol increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Blood iron decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Blood pressure increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk
Heart rate increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Heart rate irregular	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Hepatitis B antibody positive	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Liver function test abnormal	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Sinus rhythm	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Gout	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Zinc deficiency	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0009 events8 affected397 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Axillary mass	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0005 events5 affected397 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0006 events6 affected397 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Joint hyperextension	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Joint lock	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0006 events6 affected397 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0007 events7 affected397 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0003 events2 affected397 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0008 events8 affected397 at risk
Loss of consciousness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Migraine	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0006 events3 affected397 at risk
Paraesthesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Presyncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Radiculopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Syncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Anxiety	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0006 events6 affected397 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Depression	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0004 events4 affected397 at risk
Insomnia	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Intentional self-injury	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Bladder neck obstruction	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Dysuria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Haematuria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0002 events1 affected397 at risk
Renal failure	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Urinary retention	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Atrophic vulvovaginitis	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Cystocele	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0007 events7 affected397 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected397 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected397 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Madarosis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Arteriovenous fistula	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected397 at risk
Haematoma	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0003 events2 affected397 at risk
Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0005 events5 affected397 at risk

ID	Term
D013611	Tachycardia, Atrioventricular Nodal Reentry
D013617	Tachycardia, Supraventricular
D006331	Heart Diseases
D013610	Tachycardia

ID	Term
D054139	Tachycardia, Reciprocating
D001145	Arrhythmias, Cardiac
D002318	Cardiovascular Diseases
D000075224	Cardiac Conduction System Disease
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms