PRECEPT: Safety and Effectiveness of STSF Catheter Evaluated for Treating Symptomatic Persistent Atrial Fibrillation (PsAF)

• Sponsor: Biosense Webster, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02817776
• Collaborator: (none)
• Enrollment: 381
• Locations: 30
• Arm: 1
• Actual Duration (Months): 36.1
• Patients Per Site: 12.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: THERMOCOOL SMARTTOUCH® SF catheter	N/A

Detailed Description

The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL SMARTTOUCH® SF catheter in the treatment of drug refractory symptomatic persistent atrial fibrillation (PsAF) following standard electrophysiology mapping and radio frequency (RF) ablation procedures.

Study Design

• Study Type: Interventional
• Actual Enrollment: 381 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF (STSF) Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Jun 5, 2019
• Actual Study Completion Date: Jun 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.	Device: THERMOCOOL SMARTTOUCH® SF catheter; Radiofrequency Ablation

Outcome Measures

Primary Outcome Measures

1. Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days [7 days (except as noted in analysis population description)]

   The primary safety endpoint is the incidence of any early onset (within 7 days of the initial and repeat AF ablation procedure) Primary Adverse Events (AE), which are listed below: Death Atrio-esophageal fistula* Cardiac Tamponade**+/Perforation+ Myocardial infarction (MI) Stroke / Cerebrovascular accident (CVA) †, †† Thromboembolism Transient Ischemic Attack Diaphragmatic paralysis Pneumothorax Heart block PV stenosis* Pulmonary edema (Respiratory Insufficiency) Pericarditis Major Vascular access complication / bleeding

2. Effectiveness: Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 15-month Follow-up [15-month follow-up]

   The primary effectiveness endpoint for this study will be freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 15-month follow-up (post 3-Month Medication Adjustment Period followed by a 3-Month Therapy Consolidation period (Day 181-450)) and freedom from the following failure modes: Acute Procedural Failure Non-Study Catheter Failure Repeat Ablation Failure AAD Failure Surgical Failure

Secondary Outcome Measures

1. Acute Procedural Success [Immediate post-procedure]

   Acute procedural success is defined as confirmation of entrance block in all pulmonary veins.

2. 15-Month Single Procedure Success [15-Month]

   The 15-month single procedure success is defined as freedom from documented AF/AFL/AT recurrence (episodes > 30 secs) during the Evaluation Period after a single ablation procedure. Any repeat ablation procedure during the Evaluation Period will be deemed effectiveness failure for this analysis.

3. Early Onset Serious Adverse Event (SAE) [7 days]

   Occurrence of Early Onset (within 7 days of initial ablation) Serious Adverse Event

4. Peri-Procedural Serious Adverse Event (SAE) [>7 to 30 days]

   Peri-Procedural (>7 to 30 days) Serious Adverse Event

5. Late Onset Serious Adverse Event (SAE) [>30 days up to 15 months]

   Occurrence of Late Onset (>30 days) Serious Adverse Event

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Candidates for this study must meet ALL of the following criteria:

1. Documented symptomatic persistent AF, which is defined as continuous AF sustains beyond 7 days and less than 1 year and is documented by the following:.

2. Physician's note indicating continuous AF ≥ 7 days but no more than 1 year; AND

3. Two electrocardiograms (from any forms of rhythm monitoring) showing continuous AF, with electrocardiogram taken at least 7 days apart OR

4. 24-hour Holter within 90 days of the ablation procedure showing continuous AF

5. Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD.

6. Age 18 years or older.

7. Signed Patient Informed Consent Form (ICF).

8. Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria:

Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply:

1. Continuous AF > 12 months (1-Year) (Longstanding Persistent AF)

2. Previous surgical or catheter ablation for atrial fibrillation

3. Any cardiac surgery within the past 2 months (60 days) (includes percutaneous coronary intervention (PCI))

4. Coronary Artery Bypass Graft (CABG) surgery within the past 6 months (180 days)

5. Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)

6. Any carotid stenting or endarterectomy

7. Documented left atrial (LA) thrombus on imaging

8. LA size > 50 mm (parasternal long axis view)

9. Left ventricular ejection fraction (LVEF) < 40%

10. Contraindication to anticoagulation (heparin or warfarin)

11. History of blood clotting or bleeding abnormalities

12. MI within the past 2 months (60 days)

13. Documented thromboembolic event (including Transient Ischemic Attack (TIA) within the past 12 months (365 days)

14. Rheumatic Heart Disease

15. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV

16. Severe mitral regurgitation (Regurgitant volume ≥ 60 mL/beat, Regurgitant fraction ≥ 50%, and/or Effective regurgitant orifice area ≥ 0.40cm2)

17. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)

18. Unstable angina

19. Acute illness or active systemic infection or sepsis

20. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.

21. Diagnosed atrial myxoma.

22. Presence of implanted implantable cardioverter defibrillator (ICD) /cardiac resynchronization therapy defibrillator (CRT-D).

23. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.

24. Gastroesophageal Reflux Disease (GERD; active requiring significant intervention not including over-the-counter (OTC) medication)

25. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.

26. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)

27. Enrollment in an investigational study evaluating another device, biologic, or drug.

28. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.

29. Presence of any other condition that precludes appropriate vascular access.

30. Life expectancy less than 12 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Affinity Cardiovascular Specialists (Alabama Cardiovascular Group)	Birmingham	Alabama	United States	35205
2	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
3	Phoenix Cardiovascular Research Group	Phoenix	Arizona	United States	85015
4	Stanford University School of Medicine	Palo Alto	California	United States	94305
5	San Diego Cardiac Center	San Diego	California	United States	92123
6	JFK Medical Center	Atlantis	Florida	United States	92201
7	St Vincent's Medical Center	Jacksonville	Florida	United States	32204
8	Florida Hospital	Orlando	Florida	United States	32803
9	Emory Saint Joseph's Hospital	Atlanta	Georgia	United States	30342
10	University of Iowa	Iowa City	Iowa	United States	52242
11	Johns Hopkins University	Baltimore	Maryland	United States	21287
12	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
13	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
14	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407
15	Mayo Clinic Foundation	Rochester	Minnesota	United States	55902
16	Montefiore Hospital	Bronx	New York	United States	10467
17	New York University	New York	New York	United States	10003
18	Mount Sinai School of Medicine	New York	New York	United States	10029
19	New York Presbyterian Hospital - Weill Cornell Medical Center	New York	New York	United States	10065
20	St Francis Hospital	Roslyn	New York	United States	11576
21	Duke University Medical Center	Durham	North Carolina	United States	27703
22	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44109
23	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
24	Texas Health Heart & Vascular Hospital	Arlington	Texas	United States	76012
25	Texas Cardiac Arrhythmia Research	Austin	Texas	United States	78705
26	Baylor Research Institute	Plano	Texas	United States	75204
27	Sentara Heart Hospital	Norfolk	Virginia	United States	23507
28	Virginia Commonwealth University	Richmond	Virginia	United States	23284
29	St. Paul's Hospital	Vancouver	British Columbia	Canada	BC V6Z 1Y6
30	Montreal Heart Institute	Montreal	Quabec	Canada	QC H1T 1C8

Sponsors and Collaborators

• Biosense Webster, Inc.

Investigators

• Principal Investigator: Andrea Natale, MD, Texas Cardiac Arrhythmia Research
• Principal Investigator: Francis Marchlinski, MD, University of Pennsylvania
• Principal Investigator: Bruce Koplan, MD, Brigham and Women's Hospital
• Principal Investigator: Walid Saliba, MD, The Cleveland Clinic
• Principal Investigator: Tristram Banhson, MD, Duke University
• Principal Investigator: Scott Pollak, MD, AdventHealth
• Principal Investigator: Hugh Calkins, MD, Johns Hopkins University
• Principal Investigator: Moussa Mansour, MD, Massachusetts General Hospital
• Principal Investigator: Douglas Packer, MD, Mayo Clinic Foundation
• Principal Investigator: Srinivas Dukkipati, MD, Icahn School of Medicine at Mount Sinai
• Principal Investigator: Larry Chinitz, MD, NYU Langone Medical Center
• Principal Investigator: Saumil Oza, MD, St. Vincent's
• Principal Investigator: Anshul Patel, MD, Emory University Saint Joseph's Hospital
• Principal Investigator: Robert Fishel, MD, JFK Medical Center
• Principal Investigator: William Maddox, MD, University of Alabama at Birmingham
• Principal Investigator: Alexander Mazur, MD, University of Iowa
• Principal Investigator: Daniel Melby, MD, Allina Health System
• Principal Investigator: Christopher Liu, MD, New York Presbyterian Hospital
• Principal Investigator: Kenneth Ellenbogen, MD, Virginia Commonwealth University
• Principal Investigator: Chad Brodt, MD, Stanford University
• Principal Investigator: Laurent Macle, MD, Montreal Heart
• Principal Investigator: Philip Gentlesk, MD, Sentara Heart Hospital
• Principal Investigator: James B Deville, MD, Baylor Research Institute
• Principal Investigator: Charles Athill, MD, San Diego Cardiac Center
• Principal Investigator: Craig Delaughter, MD, Texas Health Heart & Vascular
• Principal Investigator: Marwan Bahu, MD, Phoenix Cardiovascular Research Group
• Principal Investigator: Jose Osorio, MD, Affinity Cardiovascular Specialists (Alabama Cardiovascular Group)
• Principal Investigator: Marc Deyell, MD, St. Paul

Study Documents (Full-Text)

• Study Protocol - Jul 31, 2018
• Statistical Analysis Plan - May 1, 2018

More Information

Publications

None provided.

• Responsible Party: Biosense Webster, Inc.
• ClinicalTrials.gov Identifier: NCT02817776
• Other Study ID Numbers: STSF-159
• First Posted: Jun 29, 2016
• Last Update Posted: Jan 12, 2021
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Biosense Webster, Inc.: Interventional; Radiofrequency Ablation; Persistent Atrial Fibrillation
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

Participant Flow

Recruitment Details	Total of 367 subjects were proposed in the protocol to be enrolled for this study. The enrollment had been completed and closed after reaching a total of 381 enrolled subjects. The last subject was enrolled on February 6th, 2018.

Arm/Group Title	Treatment Group
Arm/Group Description	Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Period Title: Overall Study
STARTED	381
COMPLETED	293
NOT COMPLETED	88

Baseline Characteristics

Arm/Group Title	Treatment Group
Arm/Group Description	Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Overall Participants	381
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	65.6 (8.72)
Sex: Female, Male (Count of Participants)
Female	110 28.9%
Male	271 71.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 1.8%
Not Hispanic or Latino	357 93.7%
Unknown or Not Reported	17 4.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 0.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	6 1.6%
White	349 91.6%
More than one race	0 0%
Unknown or Not Reported	23 6%

Outcome Measures

1. Primary Outcome

Title	Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days
Description	The primary safety endpoint is the incidence of any early onset (within 7 days of the initial and repeat AF ablation procedure) Primary Adverse Events (AE), which are listed below: Death Atrio-esophageal fistula* Cardiac Tamponade**+/Perforation+ Myocardial infarction (MI) Stroke / Cerebrovascular accident (CVA) †, †† Thromboembolism Transient Ischemic Attack Diaphragmatic paralysis Pneumothorax Heart block PV stenosis* Pulmonary edema (Respiratory Insufficiency) Pericarditis Major Vascular access complication / bleeding
Time Frame	7 days (except as noted in analysis population description)

Outcome Measure Data

Analysis Population Description

The safety population was used as the primary analysis population. Subjects with missing 3-month follow-up were excluded from the primary analysis unless the subjects experienced a Primary AE prior to the 3-month visit post-procedure. PV stenosis and AE fistula that occurred > 1 week and cardiac tamponade/perforation that occurred up to 30 days post ablation were also deemed Primary AEs.

Arm/Group Title	Treatment Group
Arm/Group Description	Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Measure Participants	344
Number [Percentage of participants]	4.7 1.2%

2. Primary Outcome

Title	Effectiveness: Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 15-month Follow-up
Description	The primary effectiveness endpoint for this study will be freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 15-month follow-up (post 3-Month Medication Adjustment Period followed by a 3-Month Therapy Consolidation period (Day 181-450)) and freedom from the following failure modes: Acute Procedural Failure Non-Study Catheter Failure Repeat Ablation Failure AAD Failure Surgical Failure
Time Frame	15-month follow-up

Outcome Measure Data

Analysis Population Description

The PP population was used as the primary analysis population. Subjects who did not complete the 15-month follow-up were considered missing and were excluded from the primary analysis unless the subjects experienced effectiveness failure prior to exiting the study.

Arm/Group Title	Treatment Group
Arm/Group Description	Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Measure Participants	297
Number [Percentage of Participants]	59.3 15.6%

3. Secondary Outcome

Title	Acute Procedural Success
Description	Acute procedural success is defined as confirmation of entrance block in all pulmonary veins.
Time Frame	Immediate post-procedure

Outcome Measure Data

Analysis Population Description

Per Protocol Population

Arm/Group Title	Treatment Group
Arm/Group Description	Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Measure Participants	333
Number [Participants]	330 86.6%

4. Secondary Outcome

Title	15-Month Single Procedure Success
Description	The 15-month single procedure success is defined as freedom from documented AF/AFL/AT recurrence (episodes > 30 secs) during the Evaluation Period after a single ablation procedure. Any repeat ablation procedure during the Evaluation Period will be deemed effectiveness failure for this analysis.
Time Frame	15-Month

Outcome Measure Data

Analysis Population Description

Per Protocol Population, n=333, minus 3 acute procedural failures and 36 missing outcomes not included in primary effectiveness endpoint calculation.

Arm/Group Title	Treatment Group
Arm/Group Description	Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Measure Participants	294
Number [Participants]	182 47.8%

5. Secondary Outcome

Title	Early Onset Serious Adverse Event (SAE)
Description	Occurrence of Early Onset (within 7 days of initial ablation) Serious Adverse Event
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

Safety Population (number of subjects with study catheter inserted) was the analysis population for secondary safety endpoints.

Arm/Group Title	Treatment Group
Arm/Group Description	Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Measure Participants	348
Number [Participants]	33 8.7%

6. Secondary Outcome

Title	Peri-Procedural Serious Adverse Event (SAE)
Description	Peri-Procedural (>7 to 30 days) Serious Adverse Event
Time Frame	>7 to 30 days

Outcome Measure Data

Analysis Population Description

Safety Population (number of subjects with study catheter inserted)

Arm/Group Title	Treatment Group
Arm/Group Description	Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Measure Participants	348
Number [Participants]	6 1.6%

7. Secondary Outcome

Title	Late Onset Serious Adverse Event (SAE)
Description	Occurrence of Late Onset (>30 days) Serious Adverse Event
Time Frame	>30 days up to 15 months

Outcome Measure Data

Analysis Population Description

Safety Population (number of subjects with study catheter inserted) and excluding subjects who exited prior to 30 days of follow up in the study.

Arm/Group Title	Treatment Group
Arm/Group Description	Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
Measure Participants	346
Number [Participants]	59 15.5%

Adverse Events

Time Frame	15 months
Arm/Group Title	Treatment Group
Arm/Group Description	Pulmonary vein isolation (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population.
All Cause Mortality
	Treatment Group
	Affected / at Risk (%)	# Events
Total	2/348 (0.6%)
Serious Adverse Events
	Treatment Group
	Affected / at Risk (%)	# Events
Total	85/348 (24.4%)
Cardiac disorders
Cardiac Tamponade	5/348 (1.4%)	5
Diaphragmatic Paralysis	1/348 (0.3%)	1
Pulmonary Edema (Respiratory Insufficiency)	5/348 (1.4%)	5
Pericarditis	2/348 (0.6%)	2
Major Vascular Access Complication / Bleeding	3/348 (0.9%)	3
Atrial Fribrillation	11/348 (3.2%)	13
Atrial Fibrillation	1/348 (0.3%)	1
Atrial Fibrillation	1/348 (0.3%)	1
Bradycardia	4/348 (1.1%)	4
Bradycardia	4/348 (1.1%)	4
Chest Pain	6/348 (1.7%)	7
Chest Pain	1/348 (0.3%)	1
Chest Pain	5/348 (1.4%)	6
Pericardial Effusion	2/348 (0.6%)	2
Pericardial Effusion	1/348 (0.3%)	1
Pericardial Effusion	1/348 (0.3%)	1
Tachycardia	11/348 (3.2%)	11
Tachycardia	10/348 (2.9%)	10
Tachycardia	1/348 (0.3%)	1
Torsade de pointes	1/348 (0.3%)	1
Torsade de pointes	1/348 (0.3%)	1
Atrial flutter	6/348 (1.7%)	7
Atrial flutter	5/348 (1.4%)	5
Atrial flutter	1/348 (0.3%)	1
Atrial flutter	1/348 (0.3%)	1
Atrial flutter	2/348 (0.6%)	2
Arrhythmia	2/348 (0.6%)	2
Arrhythmia	1/348 (0.3%)	1
Arrhythmia	1/348 (0.3%)	1
Atrioventricular block	1/348 (0.3%)	1
Atrioventricular block	1/348 (0.3%)	1
Cardiac Failure	1/348 (0.3%)	1
Cardiac Failure	1/348 (0.3%)	1
Cardiac failure congestive	4/348 (1.1%)	4
Cardiac Failure Congestive	1/348 (0.3%)	1
Cardiac Failure Congestive	3/348 (0.9%)	3
Coronary artery occlusion	1/348 (0.3%)	1
Coronary artery occlusion	1/348 (0.3%)	1
Myocardial infarction	2/348 (0.6%)	2
Myocardial infarction	2/348 (0.6%)	2
Ventricular extrasystoles	1/348 (0.3%)	1
Ventricular extrasystoles	1/348 (0.3%)	1
Ear and labyrinth disorders
Vertigo	1/348 (0.3%)	1
Vertigo	1/348 (0.3%)	1
Eye disorders
Diplopia	1/348 (0.3%)	1
Diplopia	1/348 (0.3%)	1
Gastrointestinal disorders
Esophageal Ulcer	1/348 (0.3%)	1
Esophageal Ulcer	1/348 (0.3%)	1
Abdominal pain	1/348 (0.3%)	1
Abdominal pain	1/348 (0.3%)	1
Intra-abdominal hematoma	1/348 (0.3%)	1
Intra-abdominal hematoma	1/348 (0.3%)	1
Esophageal stenosis	1/348 (0.3%)	1
Esophageal stenosis	1/348 (0.3%)	1
Small intestinal obstruction	1/348 (0.3%)	1
Small intestinal obstruction	1/348 (0.3%)	1
General disorders
Complication associated with urinary catheter	1/348 (0.3%)	1
Complication associated with urinary catheter	2/348 (0.6%)	3
Pyrexia	1/348 (0.3%)	1
Pyrexia	1/348 (0.3%)	1
Hepatobiliary disorders
Cholecystitis	1/348 (0.3%)	1
Cholecystitis	1/348 (0.3%)	1
Immune system disorders
Hypersensitivity	1/348 (0.3%)	1
Hypersensitivity	1/348 (0.3%)	1
Infections and infestations
Sepsis	3/348 (0.9%)	3
Sepsis	1/348 (0.3%)	1
Sepsis	2/348 (0.6%)	2
Campylobacter gastroenteritis	1/348 (0.3%)	1
Campylobacter gastroenteritis	1/348 (0.3%)	1
Device related infection	1/348 (0.3%)	1
Device related infection	1/348 (0.3%)	1
Influenza	2/348 (0.6%)	2
Influenza	2/348 (0.6%)	2
Pneumonia	3/348 (0.9%)	3
Pneumonia	3/348 (0.9%)	3
Injury, poisoning and procedural complications
Seroma	1/348 (0.3%)	1
Seroma	1/348 (0.3%)	1
Metabolism and nutrition disorders
Fluid overload	2/348 (0.6%)	2
Obesity	1/348 (0.3%)	1
Obesity	1/348 (0.3%)	1
Fluid Overload	2/348 (0.6%)	2
Musculoskeletal and connective tissue disorders
Back disorder	1/348 (0.3%)	1
Back disorder	1/348 (0.3%)	1
Back pain	1/348 (0.3%)	1
Back pain	1/348 (0.3%)	1
Femur Fracture	1/348 (0.3%)	1
Hip fracture	1/348 (0.3%)	1
Hip fracture	1/348 (0.3%)	1
Osteoarthritis	4/348 (1.1%)	4
Osteoarthritis	4/348 (1.1%)	4
Osteomyelitis	1/348 (0.3%)	1
Osteomyelitis	1/348 (0.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm	1/348 (0.3%)	1
Colon neoplasm	1/348 (0.3%)	1
Lung neoplasm malignant	1/348 (0.3%)	1
Lung neoplasm malignant	1/348 (0.3%)	1
Nervous system disorders
Cerebrovascular Accident (CVA) / Stroke	1/348 (0.3%)	1
Presyncope	1/348 (0.3%)	1
Presyncope	1/348 (0.3%)	1
Syncope	1/348 (0.3%)	1
Syncope	1/348 (0.3%)	1
Tremor	1/348 (0.3%)	1
Tremor	1/348 (0.3%)	1
Cerebrovascular accident (CVA) / Stroke	1/348 (0.3%)	1
Psychiatric disorders
Major depression	1/348 (0.3%)	1
Major depression	1/348 (0.3%)	1
Renal and urinary disorders
Renal Failure	1/348 (0.3%)	1
Renal Failure	1/348 (0.3%)	1
Urinary tract infection	1/348 (0.3%)	1
Urinary tract infection	1/348 (0.3%)	1
Hematuria	1/348 (0.3%)	1
Hematuria	1/348 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
Hypoxia	1/348 (0.3%)	1
Hypoxia	1/348 (0.3%)	1
Pleural effusion	2/348 (0.6%)	2
Pleural effusion	1/348 (0.3%)	1
Pleural effusion	1/348 (0.3%)	1
Pulmonary embolism	2/348 (0.6%)	2
Pulmonary embolism	1/348 (0.3%)	1
Pulmonary embolism	1/348 (0.3%)	1
Tuberculosis	1/348 (0.3%)	1
Tuberculosis	1/348 (0.3%)	1
Bronchitis viral	1/348 (0.3%)	1
Bronchitis viral	1/348 (0.3%)	1
Chronic obstructive pulmonary disease	1/348 (0.3%)	1
Chronic obstructive pulmonary disease	1/348 (0.3%)	1
Respiratory failure	2/348 (0.6%)	2
Respiratory failure	2/348 (0.6%)	2
Dyspnea	2/348 (0.6%)	2
Dyspnea	1/348 (0.3%)	1
Dyspnea	1/348 (0.3%)	1
Skin and subcutaneous tissue disorders
Cellulitis	1/348 (0.3%)	1
Cellulitis	1/348 (0.3%)	1
Squamous cell cercinoma	1/348 (0.3%)	1
Squamous cell cercinoma	1/348 (0.3%)	1
Vascular disorders
Hypertensive Crisis	1/348 (0.3%)	1
Hypertensive Crisis	1/348 (0.3%)	1
Hemorrhage	2/348 (0.6%)	2
Hemorrhage	2/348 (0.6%)	2
Other (Not Including Serious) Adverse Events
	Treatment Group
	Affected / at Risk (%)	# Events
Total	0/348 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.