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| ID | Type | Description | Link |
|---|---|---|---|
| GCO 12-1465 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | These subjects will undergo routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System. |
|
| Control arm | No Intervention | These subjects will undergo routine catheter ablation of atrial fibrillation only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boston Scientific Vessix Renal Denervation System | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence | 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). | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| AAD-free Single-procedure Freedom From AF Recurrence | AAD-free single-procedure freedom from AF recurrence through 24 months (not-including recurrences within the first 90 days of the initial ablation procedure) | up to 24 months |
| Freedom From AF Recurrence Despite Taking AADs |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Reddy, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Cardiology Associates | Sacramento | California | 95819 | United States | ||
| University of Kansas Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Renal Sympathetic Denervation PLUS Catheter Ablation | 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. |
| FG001 | Routine Catheter Abation | Routine catheter ablation of atrial fibrillation only. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Renal Sympathetic Denervation PLUS Catheter Ablation | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence | 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). | Posted | Number | recurrences | up to 12 months |
|
24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Catheter Ablation of Atrial Fibrillation PLUS Renal Sympatheti | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sam Cammack | Icahn School of Medicine at Mount Sinai | (212) 824-8931 | sam.cammack@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 8, 2016 | Aug 20, 2020 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D003714 | Denervation |
| ID | Term |
|---|---|
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
|
Freedom from AF recurrence through 24 months (not-including the pre-defined 90 day blanking period) despite taking AADs |
| up to 24 months |
| Blood Pressure Control as Compared to Baseline | Blood pressure control between the two groups as compared to baseline at 6 months, 12 months and 24 months. | baseline, 6 months, 12 months, and 24 months |
| Number of Participants With Major Adverse Cardiac Events (MACE) | 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 | within 12 months of randomization |
| Number of Participants With Serious Adverse Events (SAE) | 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 | up to 24 months |
| Left Atrial (LA) Size | LA size by TTE at baseline and at 12 months | at baseline and at 12 months |
| Ejection Fraction (EF) | 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. | at baseline and at 12 months |
| Number of Participants With Procedure Adverse Events | 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). | up to 24 months |
| Number of Anti-hypertensive Medications | Total number of anti-hypertensive medications at study end, compared between the two treatment arms | baseline and 24 months |
| Atrial Fibrillation Effect on QualiTy-of-life Questionnaire (AFEQT) | 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. | baseline, 12 months and 24 months |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02215 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Na Homolce Hospital | Prague | 15030 | Czechia |
| Siberian Biomedical Research Center Ministry of Health Russian Federation | Novosibirsk | 630055 | Russia |
| Withdrawal by Subject |
|
| BG001 | Routine Catheter Abation | Routine catheter ablation of atrial fibrillation only. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type of Atrial Fibrillation (AF) | Count of Participants | Participants |
|
| Routine Catheter Abation |
Routine catheter ablation of atrial fibrillation only. |
|
|
| Secondary | AAD-free Single-procedure Freedom From AF Recurrence | AAD-free single-procedure freedom from AF recurrence through 24 months (not-including recurrences within the first 90 days of the initial ablation procedure) | Posted | Number | recurrences | up to 24 months |
|
|
|
| Secondary | Freedom From AF Recurrence Despite Taking AADs | Freedom from AF recurrence through 24 months (not-including the pre-defined 90 day blanking period) despite taking AADs | Posted | Number | recurrences | up to 24 months |
|
|
|
| Secondary | Blood Pressure Control as Compared to Baseline | Blood pressure control between the two groups as compared to baseline at 6 months, 12 months and 24 months. | Posted | Mean | Standard Deviation | mmHg | baseline, 6 months, 12 months, and 24 months |
|
|
|
| Secondary | Number of Participants With Major Adverse Cardiac Events (MACE) | 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 | Posted | Count of Participants | Participants | within 12 months of randomization |
|
|
|
| Secondary | Number of Participants With Serious Adverse Events (SAE) | 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 | Posted | Count of Participants | Participants | up to 24 months |
|
|
|
| Secondary | Left Atrial (LA) Size | LA size by TTE at baseline and at 12 months | Posted | Mean | Standard Deviation | cm | at baseline and at 12 months |
|
|
|
| Secondary | Ejection Fraction (EF) | 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. | Posted | Mean | Standard Deviation | percent of blood | at baseline and at 12 months |
|
|
|
| Secondary | Number of Participants With Procedure Adverse Events | 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). | Posted | Count of Participants | Participants | up to 24 months |
|
|
|
| Secondary | Number of Anti-hypertensive Medications | Total number of anti-hypertensive medications at study end, compared between the two treatment arms | Posted | Mean | Standard Deviation | medications | baseline and 24 months |
|
|
|
| Secondary | Atrial Fibrillation Effect on QualiTy-of-life Questionnaire (AFEQT) | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, 12 months and 24 months |
|
|
|
| 1 |
| 28 |
| 12 |
| 28 |
| 6 |
| 28 |
| EG001 | Routine Catheter Abation | Routine catheter ablation of atrial fibrillation only. | 1 | 22 | 4 | 22 | 5 | 22 |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Cardiac Arrhythmia | Congenital, familial and genetic disorders | Systematic Assessment |
|
| Enlarged Prostate | Renal and urinary disorders | Systematic Assessment |
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| Esophageal Ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| Femoral Pseudoaneurysm | Vascular disorders | Systematic Assessment |
|
| Fever | Immune system disorders | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
|
| Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Neutropenic fever | Immune system disorders | Systematic Assessment |
|
| Pulmonary Edema | General disorders | Systematic Assessment |
|
| Renal Dysfunction | Renal and urinary disorders | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
|
| Aortic Aneurysm Dissection | Cardiac disorders | Systematic Assessment |
|
| Atypical Chest Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Blurred vision | Eye disorders | Systematic Assessment | Left eye |
|
| Groin Hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hemoptysis | Gastrointestinal disorders | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | pain after popping from jerking motion |
|
| Syncope | General disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| Systolic 12 months |
|
| Systolic 24 months |
|
| Diastolic Baseline |
|
| Diastolic 6 months |
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| Diastolic 12 months |
|
| Diastolic 24 months |
|
| 24 months |
|