Atrial FibrillationULTRA-HFIBNCT04182620
Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation
A study testing renal denervation and Catheter ablation in people with Atrial Fibrillation, run by Vivek Reddy at 13 sites in United States.
Trial summary
The purpose of the ULTRA-HFIB Pilot is to determine the role of adjunctive renal denervation (RDN) in the prevention of Atrial Fibrillation (AF) recurrence in patients scheduled for an AF ablation procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- renal denervation and Catheter ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 13 sitesUnited States
- Study dates
- 8 Jul 2020to 26 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Planned for a first-ever AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined as involving pulmonary vein isolation, as well as bidirectional block of any attempted anatomic lesion sets such as cavotricuspid isthmus line, roofline, mitral line and superior vena cava isolation must have been completed)
- History of hypertension and either:
- Documented history of SBP ≥ 160 or DBP ≥ 100 (Stage III), or
- Receiving ≥ 1 antihypertensive medication
- Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
Who cannot join
- (if any of the following are YES, subject is not eligible)
- Long-standing persistent AF (> 12 months)
- Individual with valvular AF or AF due to a reversible cause
- Prior left atrial catheter or surgical ablation for an atrial arrhythmia (before this index procedure)
- Prior left atrial surgery (such as mitral valve surgery or surgical ASD repair)
- Prior treatment with other devices for hypertension including but not limited to ROX Coupler, Mobius stent and/or the CVRx barostimulator device
Show all 31Show fewer
- NYHA Class IV Congestive Heart Failure
- Individual has renal artery anatomy that is ineligible for treatment (as determined by intra-procedural renal angiography). This includes:
- Main renal artery diameter < 3.0 mm or > 8.0 mm
- Main renal artery length < 20 mm
- Presence of renal artery stenosis of any origin ≥ 30%
- Accessory arteries with diameter ≥ 2 mm and < 3.0 mm
- Calcification in renal arteries at locations where energy is to be delivered
- Prior renal denervation procedure
- Presence of abnormal kidney tumors
- Renal artery aneurysm
- Pre-existing renal stent or history of renal artery angioplasty
- Pre-existing aortic stent or history of aortic aneurysm
- Fibromuscular disease of the renal arteries
- Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
- Individual has an estimated glomerular filtration rate (eGFR) of less than 40mL/min/1.73m2
- Inability to undergo AF catheter ablation (e.g., presence of left atrial thrombus, contraindication to all anticoagulation)
- Individual with known allergy to contrast medium not amenable to treatment
- Life expectancy of < 1 year for any medical condition
- Individual has experienced a myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of screening visit
- Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis
- Female participants who are pregnant or nursing
- Individual has known secondary hypertension
- Individual has a single functioning kidney (either congenitally or iatrogenically)
- Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements
- Patients concurrently enrolled in any other investigational drug or device trial that would interfere with the conduction of this trial
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Massachusetts General Hospital
Boston, Massachusetts, 02114
Henry Ford Hospital
Detroit, Michigan, 48202
Bellin Memorial Hospital Inc.
Green Bay, Wisconsin, 54305
Hartford Healthcare
Hartford, Connecticut, 06106
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Loma Linda University Medical
Loma Linda, California, 92354
Naples Community Hospital
Naples, Florida, 34102
Mount Sinai Hospital
New York, New York, 10029
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Arizona - Banner University Medical Center
Phoenix, Arizona, 85004
Arizona Heart Institute
Phoenix, Arizona, 85016
Pacific Heart Institute
Santa Monica, California, 90404
About this study
Official title: Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation: A Pilot Study
The purpose of the ULTRA-HFIB Pilot is to determine the role of adjunctive renal denervation (RDN) in the prevention of Atrial Fibrillation (AF) recurrence in patients scheduled for an AF ablation procedure. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).
Read the detailed description
The purpose of the ULTRA-HFIB Pilot is to determine the role of adjunctive renal denervation (RDN) in the prevention of AF recurrence in patients scheduled for an AF ablation procedure. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention). This is a prospective, controlled, single-blind, randomized trial. The pilot study will be conducted in up to 11 clinical sites in the United States and Europe.
- Conditions
- Atrial Fibrillation
- Being tested
- renal denervation, Catheter ablation
- Keywords
- renal denervation, atrial fibrillation, cardiology, electrophysiology
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal denervationDevice
Renal denervation using the Paradise renal denervation system - a dedicated RDN catheter that delivers a circumferential ring of ablative ultrasound energy
Catheter ablationDevice
Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Catheter ablation + renal denervation | Experimental | Catheter ablation + renal denervation Receives: Device: renal denervation; Device: Catheter ablation |
| Catheter ablation only | Active comparator | Catheter ablation Receives: Device: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds
Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds off Class I and III AADs (after the 90-day blanking period), defined by absence of any electrocardiographically documented AT/AF.
Measured: 12 months
Secondary outcomes (6)
Freedom from AT/AF/AFL recurrence
Freedom from AT/AF/AFL recurrence through 12 months (excluding a 90-day blanking period from the initial ablation procedure) irrespective of AADs
Measured: 12 months
Rate of procedural adverse events
Rate of procedural adverse events
Measured: 30 days
The Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire
Quality of life instrument (AFEQT) is a 20-item disease-specific scale developed to capture subjective ratings of AF disease and treatment burden. Full range score from 0-100, with higher score indicating higher level of quality of life.
Measured: 12 months
Change in office systolic blood pressure change from baseline to 12 months
Change in office systolic blood pressure change from baseline to 12 months
Measured: 12 months
AF burden at 6 months
AF burden at 6 months
Measured: 6 months
AF burden at 12 months
AF burden at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start8 Jul 2020
- Primary completion26 Feb 2025
- Study completion26 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivek Reddy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vivek Reddy, Icahn School of Medicine at Mount Sinai
- Investigators
- Vivek Reddy, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182620
- Sponsor's protocol ID
- GCO 40-5118
- Other IDs
- IRB 19-02659
- Acronym
- ULTRA-HFIB
- Status last verified
- May 2025
- First submitted
- 27 Nov 2019
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation: A Pilot Study
- ClinicalTrials.gov ID
- NCT04182620
- Acronym / sponsor ID
- ULTRA-HFIB / GCO 40-5118
- Conditions
- Atrial Fibrillation
- Keywords
- renal denervation, atrial fibrillation, cardiology, electrophysiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Vivek ReddyUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 2 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the ULTRA-HFIB Pilot is to determine the role of adjunctive renal denervation (RDN) in the prevention of Atrial Fibrillation (AF) recurrence in patients scheduled for an AF ablation procedure. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).
Detailed description
The purpose of the ULTRA-HFIB Pilot is to determine the role of adjunctive renal denervation (RDN) in the prevention of AF recurrence in patients scheduled for an AF ablation procedure. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention). This is a prospective, controlled, single-blind, randomized trial. The pilot study will be conducted in up to 11 clinical sites in the United States and Europe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter ablation + renal denervation | Experimental | Device: renal denervation, Device: Catheter ablationCatheter ablation + renal denervation |
| Catheter ablation only | Active comparator | Device: Catheter ablationCatheter ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18
- Planned for a first-ever AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined as involving pulmonary vein isolation, as well as bidirectional block of any attempted anatomic lesion sets such as cavotricuspid isthmus line, roofline, mitral line and superior vena cava isolation must have been completed)
- History of hypertension and either:
- Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
Key exclusion criteria (31 listed)
- (if any of the following are YES, subject is not eligible)
- Long-standing persistent AF (> 12 months)
- Individual with valvular AF or AF due to a reversible cause
- Prior left atrial catheter or surgical ablation for an atrial arrhythmia (before this index procedure)
- Prior left atrial surgery (such as mitral valve surgery or surgical ASD repair)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| renal denervationRenal denervation using the Paradise renal denervation system - a dedicated RDN catheter that delivers a circumferential ring of ablative ultrasound energy | Device | Catheter ablation + renal denervation |
| Catheter ablationCatheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation | Device | Catheter ablation + renal denervation, Catheter ablation only |
Primary outcome
Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds
Time frame: 12 months
Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds off Class I and III AADs (after the 90-day blanking period), defined by absence of any electrocardiographically documented AT/AF.
6 secondary outcomes
Freedom from AT/AF/AFL recurrence
Time frame: 12 months
Rate of procedural adverse events
Time frame: 30 days
The Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire
Time frame: 12 months
Change in office systolic blood pressure change from baseline to 12 months
Time frame: 12 months
AF burden at 6 months
Time frame: 6 months
AF burden at 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Reddy, MD principal investigator
Icahn School of Medicine at Mount Sinai
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing renal denervation and Catheter ablation in people with Atrial Fibrillation, run by Vivek Reddy at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.