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

Primary Purpose

Uncontrolled Hypertension, Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Boston Scientific Vessix Renal Denervation System
Sponsored by
Vivek Reddy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uncontrolled Hypertension focused on measuring renal sympathetic denervation, renal catheter ablation, hypertension

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regional Cardiology Associates
  • University of Kansas Medical Center
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Mount Sinai Hospital
  • Medical University of South Carolina
  • Na Homolce Hospital
  • Siberian Biomedical Research Center Ministry of Health Russian Federation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Control arm

Arm Description

These subjects will undergo routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.

These subjects will undergo routine catheter ablation of atrial fibrillation only.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)
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
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.
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
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
Left Atrial (LA) Size
LA size by TTE 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.
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).
Number of Anti-hypertensive Medications
Total number of anti-hypertensive medications at study end, compared between the two treatment arms
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.

Full Information

First Posted
July 5, 2012
Last Updated
October 15, 2020
Sponsor
Vivek Reddy
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1. Study Identification

Unique Protocol Identification Number
NCT01635998
Brief Title
Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation
Acronym
H-FIB
Official Title
Adjunctive Renal Denervation to Modify Hypertension and Sympathetic Tone as Upstream Therapy in the Treatment of Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 17, 2012 (Actual)
Primary Completion Date
July 11, 2019 (Actual)
Study Completion Date
July 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vivek Reddy

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncontrolled Hypertension, Atrial Fibrillation
Keywords
renal sympathetic denervation, renal catheter ablation, hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
These subjects will undergo routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
These subjects will undergo routine catheter ablation of atrial fibrillation only.
Intervention Type
Device
Intervention Name(s)
Boston Scientific Vessix Renal Denervation System
Other Intervention Name(s)
renal denervation, denervation
Intervention Description
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
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
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
Title
Left Atrial (LA) Size
Description
LA size by TTE at baseline and at 12 months
Time Frame
at baseline and at 12 months
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
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Inability to access renal vasculature Main renal arteries < 3 mm in diameter or < 20 mm in length. 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek Reddy, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Cardiology Associates
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Na Homolce Hospital
City
Prague
ZIP/Postal Code
15030
Country
Czechia
Facility Name
Siberian Biomedical Research Center Ministry of Health Russian Federation
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation

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