H-FIB: Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation

• Sponsor: Vivek Reddy (Other)
• Overall Status: Completed
• CT.gov ID: NCT01635998
• Collaborator: (none)
• Enrollment: 50
• Locations: 8
• Arms: 2
• Actual Duration (Months): 81.7
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The objective of the H-FIB trial is to determine the role of renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension for whom a catheter-based AF ablation procedure is planned. Patients will be randomized to either AF catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.

Condition or Disease	Intervention/Treatment	Phase
Uncontrolled Hypertension; Atrial Fibrillation	Device: Boston Scientific Vessix Renal Denervation System	N/A

Detailed Description

The purpose of this study is to examine the potential additional benefit of performing renal sympathetic denervation at the same time as an AF ablation procedure, in order to improve the long-term success of the AF procedure.

To take part in this study, you must meet all study requirements. Screening visit tests and procedures such as a physical exam, blood pressure, review of medical history, blood sample, and a Transthoracic Echocardiogram (TTE) are done to see if you are eligible to be in the study.

Patients who qualify for the study and provide consent will undergo catheter ablation for AF. Very thin electrode catheters, similar to long wires, will be inserted into blood vessels in the groin. Using the ablation catheter, we will "ablate" or damage the tissue adjacent to your pulmonary veins that is not behaving normally.

Immediately following the catheter ablation, patients will undergo a renal angiogram in order to assess suitability for catheter-based renal sympathetic denervation. A renal angiogram is an x-ray study of the blood vessels in the kidney to evaluate for blockage, and abnormalities that could be affecting the blood supply to the kidney. It is performed by injecting contrast dye through a catheter (a tiny tube) into the blood vessels of the kidney.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Adjunctive Renal Denervation to Modify Hypertension and Sympathetic Tone as Upstream Therapy in the Treatment of Atrial Fibrillation
• Actual Study Start Date: Sep 17, 2012
• Actual Primary Completion Date: Jul 11, 2019
• Actual Study Completion Date: Jul 11, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention arm These subjects will undergo routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.	Device: Boston Scientific Vessix Renal Denervation System; Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation. Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts; Other Names: renal denervation denervation
No Intervention: Control arm These subjects will undergo routine catheter ablation of atrial fibrillation only.

Outcome Measures

Primary Outcome Measures

1. Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence [up to 12 months]

   The primary endpoint of this study is anti-arrhythmic drug (AAD)-free single-procedure freedom from AF recurrence through 12 months (not including a 90 day blanking period).

Secondary Outcome Measures

1. AAD-free Single-procedure Freedom From AF Recurrence [up to 24 months]

   AAD-free single-procedure freedom from AF recurrence through 24 months (not-including recurrences within the first 90 days of the initial ablation procedure)

2. Freedom From AF Recurrence Despite Taking AADs [up to 24 months]

   Freedom from AF recurrence through 24 months (not-including the pre-defined 90 day blanking period) despite taking AADs

3. Blood Pressure Control as Compared to Baseline [baseline, 6 months, 12 months, and 24 months]

   Blood pressure control between the two groups as compared to baseline at 6 months, 12 months and 24 months.

4. Number of Participants With Major Adverse Cardiac Events (MACE) [within 12 months of randomization]

   Number of Participants with Major adverse cardiac events (MACE) defined as a non-weighted composite score of: death, stroke, CHF hospitalization, and clinically diagnosed thromboembolic events other than stroke and hemorrhage requiring transfusion within 12 months of randomization

5. Number of Participants With Serious Adverse Events (SAE) [up to 24 months]

   SAE-any experience that results in a fatality or is life threatening; results in significant or persistent disability; requires or prolongs hospitalization; results in congenital anomaly/birth defect; or represents other significant hazards or potentially serious harm to research subjects or others, in the opinion of the investigators. Important medical events that may not result in above may be considered a SAE when, based upon appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition

6. Left Atrial (LA) Size [at baseline and at 12 months]

   LA size by TTE at baseline and at 12 months

7. Ejection Fraction (EF) [at baseline and at 12 months]

   Ejection fraction (EF) is a measurement, expressed as a percentage, of how much blood the left ventricle pumps out with each contraction. A normal heart's ejection fraction may be between 50 and 70 percent.

8. Number of Participants With Procedure Adverse Events [up to 24 months]

   Causality will be defined as adverse events that, after careful medical evaluation, are considered with a high degree of certainty to be related to the intervention (AF ablation ± renal sympathetic denervation).

9. Number of Anti-hypertensive Medications [baseline and 24 months]

   Total number of anti-hypertensive medications at study end, compared between the two treatment arms

10. Atrial Fibrillation Effect on QualiTy-of-life Questionnaire (AFEQT) [baseline, 12 months and 24 months]

    The change in quality of life (QoL) from baseline to 12 months as measured by AFEQT, a 20- item instrument. Full range from 0 to 100, with higher score indicates higher level of QoL.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Inclusion Criteria

• Age ≥ 18 years of age

• History of AF (paroxysmal or persistent) and planned for a guideline-supported catheter ablation procedure

• History of significant hypertension (defined as SBP ≥160 mm Hg and/or DBP ≥100 mmHg) and receiving treatment with at least one anti-hypertensive medication OR Clinical History of hypertension and receiving treatment with at least two anti-hypertensive medications (specifically for blood pressure reduction).

• Renal vasculature is accessible as determined by intra-procedural renal angiography.

• Ability to understand the requirements of the study

• Willingness to adhere to study restrictions, comply with all post-procedural follow-up requirements and to sign informed consent

Exclusion Criteria

• Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)

• Prior left atrial ablation for an atrial arrhythmia (before this index procedure)

• Patients with NYHA class IV congestive heart failure

• Individual has known secondary hypertension

• Individual has renal artery anatomy that is ineligible for treatment including:

1. Inability to access renal vasculature

2. Main renal arteries < 3 mm in diameter or < 20 mm in length.

3. Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal artery or meets standards for surgical repair or interventional dilation.

4. A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment.

• Individual has an estimated glomerular filtration rate (eGFR) of less than 45mL/min/1.73m2, using the MDRD calculation.

• Individual has a single functioning kidney (either congenitally or iatrogenically).

• Individual is pregnant or nursing.

• Life expectancy <1 year for any medical condition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regional Cardiology Associates	Sacramento	California	United States	95819
2	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
4	Brigham and Women's Hospital	Boston	Massachusetts	United States	02215
5	Mount Sinai Hospital	New York	New York	United States	10029
6	Medical University of South Carolina	Charleston	South Carolina	United States	29425
7	Na Homolce Hospital	Prague		Czechia	15030
8	Siberian Biomedical Research Center Ministry of Health Russian Federation	Novosibirsk		Russian Federation	630055

Sponsors and Collaborators

• Vivek Reddy

Investigators

• Principal Investigator: Vivek Reddy, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 8, 2016

More Information

Publications

None provided.

• Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Professor of Medicine, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT01635998
• Other Study ID Numbers: GCO 12-1465; GCO 12-1465
• First Posted: Jul 10, 2012
• Last Update Posted: Nov 5, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Vivek Reddy, Director Cardiac Arrhythmia Service, Professor of Medicine, Icahn School of Medicine at Mount Sinai: renal sympathetic denervation; renal catheter ablation; hypertension
• Additional relevant MeSH terms: Hypertension; Atrial Fibrillation

Study Results

Participant Flow

Arm/Group Title	Renal Sympathetic Denervation PLUS Catheter Ablation	Routine Catheter Abation
Arm/Group Description	Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System. Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.	Routine catheter ablation of atrial fibrillation only.
Period Title: Overall Study
STARTED	28	22
COMPLETED	24	15
NOT COMPLETED	4	7

Baseline Characteristics

Arm/Group Title	Renal Sympathetic Denervation PLUS Catheter Ablation	Routine Catheter Abation	Total
Arm/Group Description	Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System. Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.	Routine catheter ablation of atrial fibrillation only.	Total of all reporting groups
Overall Participants	28	22	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.4 (6.9)	65.3 (8.2)	65.17 (7.9)
Sex: Female, Male (Count of Participants)
Female	12 42.9%	8 36.4%	20 40%
Male	16 57.1%	14 63.6%	30 60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	28 100%	22 100%	50 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	28 100%	22 100%	50 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Type of Atrial Fibrillation (AF) (Count of Participants)
Paroxysmal AF	20 71.4%	15 68.2%	35 70%
Persistent AF	8 28.6%	7 31.8%	15 30%

Outcome Measures

1. Primary Outcome

Title	Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence
Description	The primary endpoint of this study is anti-arrhythmic drug (AAD)-free single-procedure freedom from AF recurrence through 12 months (not including a 90 day blanking period).
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Renal Sympathetic Denervation PLUS Catheter Ablation	Routine Catheter Abation
Arm/Group Description	Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System. Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.	Routine catheter ablation of atrial fibrillation only.
Measure Participants	28	22
Number [recurrences]	6	2

2. Secondary Outcome

Title	AAD-free Single-procedure Freedom From AF Recurrence
Description	AAD-free single-procedure freedom from AF recurrence through 24 months (not-including recurrences within the first 90 days of the initial ablation procedure)
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Renal Sympathetic Denervation PLUS Catheter Ablation	Routine Catheter Abation
Arm/Group Description	Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System. Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.	Routine catheter ablation of atrial fibrillation only.
Measure Participants	28	22
Number [recurrences]	7	6

3. Secondary Outcome

Title	Freedom From AF Recurrence Despite Taking AADs
Description	Freedom from AF recurrence through 24 months (not-including the pre-defined 90 day blanking period) despite taking AADs
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Renal Sympathetic Denervation PLUS Catheter Ablation	Routine Catheter Abation
Arm/Group Description	Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System. Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.	Routine catheter ablation of atrial fibrillation only.
Measure Participants	28	22
Number [recurrences]	6	5

4. Secondary Outcome

Title	Blood Pressure Control as Compared to Baseline
Description	Blood pressure control between the two groups as compared to baseline at 6 months, 12 months and 24 months.
Time Frame	baseline, 6 months, 12 months, and 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Renal Sympathetic Denervation PLUS Catheter Ablation	Routine Catheter Abation
Arm/Group Description	Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System. Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.	Routine catheter ablation of atrial fibrillation only.
Measure Participants	28	22
Systolic Baseline	146.6 (20.6)	143.45 (18.47)
Systolic 6 months	136.88 (17.36)	142.06 (78.94)
Systolic 12 months	137.88 (17.55)	144.53 (21.6)
Systolic 24 months	133.88 (14.4)	138.7 (19.9)
Diastolic Baseline	81.46 (13.4)	79.18 (12.45)
Diastolic 6 months	80.88 (10.08)	78.94 (7.8)
Diastolic 12 months	82.36 (9.19)	82.03 (6.6)
Diastolic 24 months	79.8 (7.48)	78.87 (9.75)

5. Secondary Outcome

Title	Number of Participants With Major Adverse Cardiac Events (MACE)
Description	Number of Participants with Major adverse cardiac events (MACE) defined as a non-weighted composite score of: death, stroke, CHF hospitalization, and clinically diagnosed thromboembolic events other than stroke and hemorrhage requiring transfusion within 12 months of randomization
Time Frame	within 12 months of randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Renal Sympathetic Denervation PLUS Catheter Ablation	Routine Catheter Abation
Arm/Group Description	Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System. Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.	Routine catheter ablation of atrial fibrillation only.
Measure Participants	28	22
Count of Participants [Participants]	0 0%	1 4.5%

6. Secondary Outcome

Title	Number of Participants With Serious Adverse Events (SAE)
Description	SAE-any experience that results in a fatality or is life threatening; results in significant or persistent disability; requires or prolongs hospitalization; results in congenital anomaly/birth defect; or represents other significant hazards or potentially serious harm to research subjects or others, in the opinion of the investigators. Important medical events that may not result in above may be considered a SAE when, based upon appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Renal Sympathetic Denervation PLUS Catheter Ablation	Routine Catheter Abation
Arm/Group Description	Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System. Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.	Routine catheter ablation of atrial fibrillation only.
Measure Participants	28	22
Count of Participants [Participants]	5 17.9%	1 4.5%

7. Secondary Outcome

Title	Left Atrial (LA) Size
Description	LA size by TTE at baseline and at 12 months
Time Frame	at baseline and at 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Renal Sympathetic Denervation PLUS Catheter Ablation	Routine Catheter Abation
Arm/Group Description	Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System. Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.	Routine catheter ablation of atrial fibrillation only.
Measure Participants	28	22
Baseline	5.4 (0.8)	4.7 (1.3)
12 months	5.19 (0.9)	4.68 (1.4)

8. Secondary Outcome

Title	Ejection Fraction (EF)
Description	Ejection fraction (EF) is a measurement, expressed as a percentage, of how much blood the left ventricle pumps out with each contraction. A normal heart's ejection fraction may be between 50 and 70 percent.
Time Frame	at baseline and at 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Renal Sympathetic Denervation PLUS Catheter Ablation	Routine Catheter Abation
Arm/Group Description	Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System. Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.	Routine catheter ablation of atrial fibrillation only.
Measure Participants	28	22
Baseline	62.52 (6.88)	63.84 (6.25)
12 months	62.9 (7.21)	64.5 (4.53)

9. Secondary Outcome

Title	Number of Participants With Procedure Adverse Events
Description	Causality will be defined as adverse events that, after careful medical evaluation, are considered with a high degree of certainty to be related to the intervention (AF ablation ± renal sympathetic denervation).
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Renal Sympathetic Denervation PLUS Catheter Ablation	Routine Catheter Abation
Arm/Group Description	Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System. Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.	Routine catheter ablation of atrial fibrillation only.
Measure Participants	28	22
Count of Participants [Participants]	6 21.4%	1 4.5%

10. Secondary Outcome

Title	Number of Anti-hypertensive Medications
Description	Total number of anti-hypertensive medications at study end, compared between the two treatment arms
Time Frame	baseline and 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Renal Sympathetic Denervation PLUS Catheter Ablation	Routine Catheter Abation
Arm/Group Description	Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System. Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.	Routine catheter ablation of atrial fibrillation only.
Measure Participants	28	22
Baseline	2.8 (0.95)	2.5 (1.0)
24 months	2.8 (1.0)	2.35 (1.0)

11. Secondary Outcome

Title	Atrial Fibrillation Effect on QualiTy-of-life Questionnaire (AFEQT)
Description	The change in quality of life (QoL) from baseline to 12 months as measured by AFEQT, a 20- item instrument. Full range from 0 to 100, with higher score indicates higher level of QoL.
Time Frame	baseline, 12 months and 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Renal Sympathetic Denervation PLUS Catheter Ablation	Routine Catheter Abation
Arm/Group Description	Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System. Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.	Routine catheter ablation of atrial fibrillation only.
Measure Participants	28	22
Baseline	72.75 (22.85)	75.4 (26.54)
12 months	37.95 (16.13)	30 (11.58)
24 months	39.8 (20.32)	36.57 (21.1)

Adverse Events

Time Frame	24 months
Arm/Group Title	Catheter Ablation of Atrial Fibrillation PLUS Renal Sympatheti		Routine Catheter Abation
Arm/Group Description	Routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System. Boston Scientific Vessix Renal Denervation System: Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.		Routine catheter ablation of atrial fibrillation only.
All Cause Mortality
	Catheter Ablation of Atrial Fibrillation PLUS Renal Sympatheti		Routine Catheter Abation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/28 (3.6%)		1/22 (4.5%)
Serious Adverse Events
	Catheter Ablation of Atrial Fibrillation PLUS Renal Sympatheti		Routine Catheter Abation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/28 (42.9%)		4/22 (18.2%)
Blood and lymphatic system disorders
Bleeding	1/28 (3.6%)		0/22 (0%)
Congenital, familial and genetic disorders
Cardiac Arrhythmia	1/28 (3.6%)		0/22 (0%)
Gastrointestinal disorders
Esophageal Ulcer	1/28 (3.6%)		0/22 (0%)
Gastroenteritis	1/28 (3.6%)		0/22 (0%)
General disorders
Pulmonary Edema	0/28 (0%)		1/22 (4.5%)
Immune system disorders
Fever	1/28 (3.6%)		0/22 (0%)
Neutropenic fever	1/28 (3.6%)		0/22 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer	1/28 (3.6%)		0/22 (0%)
Lung Cancer	1/28 (3.6%)		0/22 (0%)
Renal and urinary disorders
Enlarged Prostate	0/28 (0%)		1/22 (4.5%)
Renal Dysfunction	1/28 (3.6%)		0/22 (0%)
Urinary Retention	0/28 (0%)		2/22 (9.1%)
Vascular disorders
Femoral Pseudoaneurysm	3/28 (10.7%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Catheter Ablation of Atrial Fibrillation PLUS Renal Sympatheti		Routine Catheter Abation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/28 (21.4%)		5/22 (22.7%)
Blood and lymphatic system disorders
Anemia	1/28 (3.6%)		0/22 (0%)
Bleeding	0/28 (0%)		2/22 (9.1%)
Cardiac disorders
Aortic Aneurysm Dissection	0/28 (0%)		1/22 (4.5%)
Eye disorders
Blurred vision	1/28 (3.6%)		0/22 (0%)
Gastrointestinal disorders
Hemoptysis	1/28 (3.6%)		0/22 (0%)
General disorders
Syncope	1/28 (3.6%)		0/22 (0%)
Musculoskeletal and connective tissue disorders
Atypical Chest Pain	0/28 (0%)		1/22 (4.5%)
Neck Pain	0/28 (0%)		1/22 (4.5%)
Skin and subcutaneous tissue disorders
Groin Hematoma	1/28 (3.6%)		0/22 (0%)
Hematoma	1/28 (3.6%)		0/22 (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.