Trial Outcomes & Findings for Autologous Stem Cells for Cardiac Angiogenesis (FOCUS HF) (NCT NCT00203203)

NCT ID: NCT00203203

Last Updated: 2016-11-28

Results Overview

Safety of cell injections was assessed by reviewing adverse events at 3 time points: (1) up to 2 weeks post-procedure), (2) 3 months post-procedure, and (3) at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF \[CHF\], acute coronary syndrome, myocardial infarction, stroke, or death).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

30 participants

Primary outcome timeframe

up to 2 weeks post-procedure, 3 months and 6 months

Results posted on

2016-11-28

Participant Flow

Thirty patients were recruited between 4/14/04 and 2/8/07 from outpatient cardiology clinics.

Participant milestones

Participant milestones
Measure	Control, Then Stem Cell Therapy Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy.	Stem Cell Therapy Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Overall Study STARTED	10	20
Overall Study COMPLETED	9	20
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Autologous Stem Cells for Cardiac Angiogenesis (FOCUS HF)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control, Then Stem Cell Therapy n=10 Participants Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy.	Stem Cell Therapy n=20 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	56.3 years STANDARD_DEVIATION 8.6 • n=5 Participants	60.5 years STANDARD_DEVIATION 6.4 • n=7 Participants	60.0 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	15 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	20 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 2 weeks post-procedure, 3 months and 6 months

Population: Adverse events which occurred in all participants.

Outcome measures

Outcome measures
Measure	Control, Then Stem Cell Therapy n=10 Participants Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy.	Stem Cell Therapy n=20 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Safety of Autologous-bone-marrow Injections post-procedural transient left bundle branch block	1 participants	1 participants
Safety of Autologous-bone-marrow Injections Post-procedure pericardial effusion (nonsignifiant	0 participants	1 participants
Safety of Autologous-bone-marrow Injections Post-procedure transient fever	1 participants	0 participants
Safety of Autologous-bone-marrow Injections Fever (6 months)	2 participants	0 participants
Safety of Autologous-bone-marrow Injections Sustained ventricular arrhythmias (6 months)	0 participants	0 participants
Safety of Autologous-bone-marrow Injections Discharge implantable cardiac defibrillator (6 mo)	0 participants	1 participants
Safety of Autologous-bone-marrow Injections Exacerbation of congestive heart failure (6 mo)	1 participants	2 participants
Safety of Autologous-bone-marrow Injections Myocardial infarction (6 months)	0 participants	0 participants
Safety of Autologous-bone-marrow Injections Death (6 months)	0 participants	0 participants

SECONDARY outcome

Timeframe: baseline, 3 months and 6 months

Population: The data was analyzed for all participants in control and treated groups.

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain). Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation)

Outcome measures

Outcome measures
Measure	Control, Then Stem Cell Therapy n=10 Participants Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy.	Stem Cell Therapy n=20 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Canadian Cardiovascular (CCS) Angina Score CCS baseline	3 units on a scale Standard Deviation 0.3	3 units on a scale Standard Deviation 0.2
Canadian Cardiovascular (CCS) Angina Score CCS 3 months	2.2 units on a scale Standard Deviation 0.3	2.1 units on a scale Standard Deviation 0.2
Canadian Cardiovascular (CCS) Angina Score CCS 6 months	2.6 units on a scale Standard Deviation 0.3	1.8 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: baseline, 3 months and 6 months

Population: The data was analyzed for all participants in control and treated groups.

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity. Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound)

Outcome measures

Outcome measures
Measure	Control, Then Stem Cell Therapy n=10 Participants Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy.	Stem Cell Therapy n=20 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
New York Heart Association (NYHA)Classification NYHA Baseline	2.6 NYHA Functional Class Standard Deviation 0.3	2.3 NYHA Functional Class Standard Deviation 0.2
New York Heart Association (NYHA)Classification NYHA 3 months	1.9 NYHA Functional Class Standard Deviation 0.3	2 NYHA Functional Class Standard Deviation 0.2
New York Heart Association (NYHA)Classification NYHA 6 months	2.4 NYHA Functional Class Standard Deviation 0.3	1.8 NYHA Functional Class Standard Deviation 0.2

SECONDARY outcome

Timeframe: baseline, 3 months and 6 months

Population: The data was analyzed for all participants in control and treated groups.

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute.

Outcome measures

Outcome measures
Measure	Control, Then Stem Cell Therapy n=10 Participants Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy.	Stem Cell Therapy n=20 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Myocardial Oxygen Consumption (MVO2) MVO2 (ml/kg per min) baseline	14.8 Percentage of Oxygen Saturation Standard Deviation 0.8	14.7 Percentage of Oxygen Saturation Standard Deviation 0.6
Myocardial Oxygen Consumption (MVO2) MVO2 (ml/kg per min) 3 months	15.7 Percentage of Oxygen Saturation Standard Deviation 0.8	15.5 Percentage of Oxygen Saturation Standard Deviation 0.6
Myocardial Oxygen Consumption (MVO2) MVO2 (ml/kg per min) 6 months	15.6 Percentage of Oxygen Saturation Standard Deviation 0.9	15.8 Percentage of Oxygen Saturation Standard Deviation 0.6

SECONDARY outcome

Timeframe: baseline, 3 months and 6 months

Population: The data was analyzed for all participants in control and treated groups.

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.

Outcome measures

Outcome measures
Measure	Control, Then Stem Cell Therapy n=10 Participants Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy.	Stem Cell Therapy n=20 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Echocardiography (EF)Percent (%) Echocardiography EF (%) 3 months	41 Ejection Fraction % Standard Deviation 5.4	38 Ejection Fraction % Standard Deviation 5.4
Echocardiography (EF)Percent (%) Echocardiography EF (%) baseline	39 Ejection Fraction % Standard Deviation 9.1	37 Ejection Fraction % Standard Deviation 10.6
Echocardiography (EF)Percent (%) Echocardiography EF (%) 6 months	42 Ejection Fraction % Standard Deviation 5.4	40 Ejection Fraction % Standard Deviation 5.4

SECONDARY outcome

Timeframe: baseline and 3 months

Population: The data was analyzed for all participants in control and treated groups.

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 slope)measure during a cardiopulmonary exercise test has a high prognostic value for survival in heart failure patients. Normal VE (milliliters per minute)/VCO2 (milliliters per minute)equals 25.

Outcome measures

Outcome measures
Measure	Control, Then Stem Cell Therapy n=10 Participants Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy.	Stem Cell Therapy n=20 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope) VE/VCO2 baseline	29.8 VE/VCO2 slope Standard Deviation 8	32.7 VE/VCO2 slope Standard Deviation 6
Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope) VE/VCO2 3 months	32.8 VE/VCO2 slope Standard Deviation 5	31.8 VE/VCO2 slope Standard Deviation 7

SECONDARY outcome

Timeframe: baseline and 3 months

Population: The data was analyzed for all participants in control and treated groups.

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI)which allows detection of abnormalities in the heart wall or blood flowing through the heart. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments.

Outcome measures

Outcome measures
Measure	Control, Then Stem Cell Therapy n=10 Participants Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy.	Stem Cell Therapy n=20 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Echocardiography Wall Motion Score Index (WMSI) Wall Motion Score Index (WMSI) baseline	1.7 Wall Motion Score Index Standard Deviation 0.5	1.7 Wall Motion Score Index Standard Deviation 0.5
Echocardiography Wall Motion Score Index (WMSI) Wall Motion Score Index (WMSI) 3 months	1.6 Wall Motion Score Index Standard Deviation 0.4	1.7 Wall Motion Score Index Standard Deviation 0.6

SECONDARY outcome

Timeframe: baseline, 3 months and 6 months

Population: The data was analyzed for all participants in control and treated groups.

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Single-photon emission computed tomography (SPECT) imaging for Left Ventricular Ejection Fraction (LVEF) percentage (%)to determine how well the heart is pumping blood from the left ventricle. Different method for evaluating how much (%) of blood is pumped through heart with each contraction.

Outcome measures

Outcome measures
Measure	Control, Then Stem Cell Therapy n=10 Participants Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy.	Stem Cell Therapy n=20 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%) SPECT LVEF (%) baseline	43 Left Ventricular Ejection Fraction (%) Standard Deviation 10.4	41.5 Left Ventricular Ejection Fraction (%) Standard Deviation 11.2
Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%) SPECT LVEF (%) 3 months	46.8 Left Ventricular Ejection Fraction (%) Standard Deviation 9.5	43.2 Left Ventricular Ejection Fraction (%) Standard Deviation 11.1
Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%) SPECT LVEF (%) 6 months	47.8 Left Ventricular Ejection Fraction (%) Standard Deviation 7.5	44 Left Ventricular Ejection Fraction (%) Standard Deviation 13.4

SECONDARY outcome

Timeframe: baseline and 6 months

Population: The data was analyzed for all participants in control and treated groups.

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using angiography left ventricular ejection fraction (LVEF) percent (%) which is an invasive method used to estimate how well the heart is pumping blood through the ventricle and is considered the "gold" standard.

Outcome measures

Outcome measures
Measure	Control, Then Stem Cell Therapy n=10 Participants Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy.	Stem Cell Therapy n=20 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%) Angiography LVEF (%) baseline	40 Angiography LVEF (%) Standard Deviation 3.2	37.5 Angiography LVEF (%) Standard Deviation 8.2
Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%) Angiography LVEF (%) 6 months	40.9 Angiography LVEF (%) Standard Deviation 8.5	42 Angiography LVEF (%) Standard Deviation 14.4

SECONDARY outcome

Timeframe: baseline, 3 months and 6 months

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters.

Outcome measures

Outcome measures
Measure	Control, Then Stem Cell Therapy n=10 Participants Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy.	Stem Cell Therapy n=20 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Left Ventricular End-Diastolic Volume (LVEDV) LVEDV (ml) baseline	132.2 Volume in left ventricle (milliliters) Standard Deviation 43.6	133.2 Volume in left ventricle (milliliters) Standard Deviation 53.6
Left Ventricular End-Diastolic Volume (LVEDV) LVEDV (ml) 3 months	125.7 Volume in left ventricle (milliliters) Standard Deviation 46.3	123.9 Volume in left ventricle (milliliters) Standard Deviation 58.2
Left Ventricular End-Diastolic Volume (LVEDV) LVEDV (ml) 6 months	120.0 Volume in left ventricle (milliliters) Standard Deviation 30.9	123.9 Volume in left ventricle (milliliters) Standard Deviation 39.7

SECONDARY outcome

Timeframe: baseline, 3 months and 6 months

Population: The data was analyzed for all participants in control and treated groups.

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV)when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters.

Outcome measures

Outcome measures
Measure	Control, Then Stem Cell Therapy n=10 Participants Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy.	Stem Cell Therapy n=20 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Left Ventricular End-Systolic Volume (LVESV) (ml) LVESV (ml) baseline	81.7 ml Standard Deviation 40.7	92.9 ml Standard Deviation 50.5
Left Ventricular End-Systolic Volume (LVESV) (ml) LVESV (ml) 3 months	74.4 ml Standard Deviation 37	83.2 ml Standard Deviation 43.2
Left Ventricular End-Systolic Volume (LVESV) (ml) LVESV (ml) 6 months	71.8 ml Standard Deviation 27.2	74 ml Standard Deviation 29.5

SECONDARY outcome

Timeframe: baseline and 6 months

Population: The data was analyzed for all participants in control and treated groups.

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Endocardial Unipolar Voltages (UPV)in millivolts(mV)which may be indicative of scar tissue. Normal is \<5.5 mV.

Outcome measures

Outcome measures
Measure	Control, Then Stem Cell Therapy n=10 Participants Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy.	Stem Cell Therapy n=20 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Endocardial Unipolar Voltages (UPV) UPV (mV) baseline	10.2 Unipolar voltage (mV) Standard Deviation 4.3	10.5 Unipolar voltage (mV) Standard Deviation 5.1
Endocardial Unipolar Voltages (UPV) UPV (mV) 6 months	10.1 Unipolar voltage (mV) Standard Deviation 4.8	10.8 Unipolar voltage (mV) Standard Deviation 5.4

SECONDARY outcome

Timeframe: baseline and 6 months

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Linear Local Shortening (LLS)which is an indicator of mechanical properties of the heart and measured as a percentage (%)of local contraction.

Outcome measures

Outcome measures
Measure	Control, Then Stem Cell Therapy n=10 Participants Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy.	Stem Cell Therapy n=20 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Linear Local Shortening (LLS) LLS (%) 6 months	9.1 percentage of linear local shortening Standard Deviation 6.4	10.8 percentage of linear local shortening Standard Deviation 6.8
Linear Local Shortening (LLS) LLS (%) baseline	12.1 percentage of linear local shortening Standard Deviation 6.8	10.5 percentage of linear local shortening Standard Deviation 7.3

Adverse Events

Control, Then Stem Cell Therapy

Serious events: 7 serious events

Other events: 9 other events

Deaths: 0 deaths

Stem Cell Therapy

Serious events: 11 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Emerson C. Perin, M.D., Ph.D.

Texas Heart Institute

Phone: 832-355-9405

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Control, Then Stem Cell Therapy n=10 participants at risk Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy.	Stem Cell Therapy n=20 participants at risk Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Cardiac disorders Chest pain and slightly elevated Troponin I	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	5.0% 1/20 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Nervous system disorders Confusion/disorientation	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	5.0% 1/20 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Cardiac disorders Elevated troponin,chestpain and fever with episode of cellulitis	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	5.0% 1/20 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Infections and infestations False positive culture on processed stem cells at day 5	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	5.0% 1/20 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Cardiac disorders Hospitalized for chest pain	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	5.0% 1/20 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Cardiac disorders Hospitalized for heart failure at one year	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	5.0% 1/20 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Cardiac disorders Myocardial infarction	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	5.0% 1/20 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Cardiac disorders Placement of AICD	20.0% 2/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	5.0% 1/20 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Cardiac disorders Pulmonary edema & slightly elevated Troponin I with ablation of atrial fibrillation	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	5.0% 1/20 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Respiratory, thoracic and mediastinal disorders Pulmonary edema within 24 hrs of treatment	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	0.00% 0/20 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Cardiac disorders Replacement of AICD	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	10.0% 2/20 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Cardiac disorders Restenosis without symptoms at 6 months, received stent	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	10.0% 2/20 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Infections and infestations Staph aureus septicemia (left sternoclavicular area) leg	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	0.00% 0/20 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Cardiac disorders Troponin I elevation in presence of new onset Atrial fibrillation	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	5.0% 1/20 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	5.0% 1/20 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Renal and urinary disorders Urosepsis	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	0.00% 0/20 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Musculoskeletal and connective tissue disorders back pain	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	5.0% 1/20 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Cardiac disorders bronchitis, decompensated heart failure	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	0.00% 0/20 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Cardiac disorders decompensated heart failure	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	5.0% 1/20 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Cardiac disorders elevated Troponin T in presence of bacteremia	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	0.00% 0/20 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Cardiac disorders supraventricular tachycardia ablation	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	10.0% 2/20 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Cardiac disorders unstable angina and stent	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	0.00% 0/20 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Cardiac disorders urosepsis and chest pain	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	0.00% 0/20 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Cardiac disorders ventricular tachycardia during 6 month F/Ucath requiring cardioversion	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.	0.00% 0/20 • Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.