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Procedure
Renal Denervation for Atrial Fibrillation
N/A
Recruiting
Led By Vivek Reddy, MD
Research Sponsored by Vivek Reddy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of hypertension with documented history of SBP≥160 or DBP≥100, or receiving ≥1 antihypertensive medication
Age ≥ 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months
Awards & highlights
Study Summary
This trial will study how blocking nerves in the kidneys can help reduce recurrence of an irregular heart rhythm (Atrial Fibrillation) in people with high blood pressure.
Who is the study for?
This trial is for adults over 18 with a history of hypertension and atrial fibrillation, who have had a successful AF ablation before and are scheduled for another. They must be willing to follow the study's rules and attend all follow-ups. People can't join if they've had an AF ablation recently, severe heart failure, certain kidney issues or artery problems, drug/alcohol dependency, other device treatments for hypertension, or inflammatory bowel disease.Check my eligibility
What is being tested?
The ULTRA-HFIB-Redo trial is testing whether adding renal sympathetic denervation to the usual catheter ablation treatment helps prevent atrial fibrillation from coming back in patients with high blood pressure. Participants will either receive just the catheter ablation (control) or both procedures (intervention), assigned randomly at a ratio of two intervention participants to one control.See study design
What are the potential side effects?
Possible side effects include discomfort at the site where catheters enter the body, bleeding or bruising there too; damage to blood vessels; adverse reactions to contrast dye used during procedures; worsening kidney function; and risks associated with sedation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have high blood pressure or am on medication for it.
Select...
I am 18 years old or older.
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I am scheduled for another AF ablation after a successful first procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from atrial arrhythmias with no AADs
Secondary outcome measures
Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT)
Blood pressure
Freedom from atrial arrhythmias (AT/AF/AFL) with AADs
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Catheter ablation + renal denervationExperimental Treatment2 Interventions
Catheter ablation + renal denervation
Group II: Catheter ablation onlyActive Control1 Intervention
Catheter ablation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Catheter Ablation
2009
Completed Phase 4
~3720
Renal Denervation
2013
Completed Early Phase 1
~360
Find a Location
Who is running the clinical trial?
Vivek ReddyLead Sponsor
20 Previous Clinical Trials
5,156 Total Patients Enrolled
10 Trials studying Atrial Fibrillation
875 Patients Enrolled for Atrial Fibrillation
Vivek Reddy, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
33 Previous Clinical Trials
11,096 Total Patients Enrolled
18 Trials studying Atrial Fibrillation
5,662 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used other devices for treating high blood pressure before, such as the ROX Coupler, Mobius stent, or the CVRx barostimulator device.The main blood vessel in the kidney is less than 20 millimeters long and can be treated.You are not expected to live for more than 1 year due to a medical condition.I have significant scarring in the left side of my heart.I have a stent in my aorta or a history of an aortic aneurysm.I had a procedure to correct heart rhythm (AF ablation) within the last 3 months.I have a condition affecting the muscles of my kidney arteries.I cannot have the Paradise Catheter due to narrowed arteries in my hip or thigh.You have a known allergy to contrast dye that cannot be treated.I have severe heart failure.I do not have a current drug or alcohol problem and can follow study instructions.My main renal artery is either less than 3mm or more than 8mm in diameter.You have calcification in the arteries of your kidneys.I have a narrowing of the arteries to my kidneys of 30% or more.I have a bulge in the artery that supplies blood to my kidney.I haven't had a heart attack, stroke, or heart failure that required hospitalization in the last 3 months.I have high blood pressure or am on medication for it.I am 18 years old or older.I have only one working kidney.My high blood pressure is caused by another health condition.My kidney's blood vessels are not suitable for treatment.I have a renal stent or had a procedure to open my kidney arteries.I have a long-term inflammatory bowel condition like Crohn's disease or ulcerative colitis.I am scheduled for another AF ablation after a successful first procedure.I have abnormal tumors in my kidneys.Your kidney function, measured by eGFR, is too low (less than 40mL/min/1.73m2).I have undergone a kidney nerve ablation procedure.My atrial fibrillation is due to a heart valve issue or a temporary cause.I cannot have a procedure to treat irregular heartbeats using catheters.I have had atrial fibrillation for more than a year.I have had more than 3 procedures to correct heart rhythm problems.
Research Study Groups:
This trial has the following groups:- Group 1: Catheter ablation only
- Group 2: Catheter ablation + renal denervation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor currently enrolling participants?
"As detailed on clinicaltrials.gov, the openings for this specific trial have been filled as of August 4th 2023. Nonetheless, there are 493 other trials seeking participants at this time."
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