Renal Denervation + AF Ablation for Atrial Fibrillation
(ULTRA-HFIB Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether adding renal denervation—a procedure that reduces nerve activity affecting the kidneys—can help prevent atrial fibrillation (AF) from recurring in individuals already scheduled for a standard AF ablation procedure (also known as catheter ablation or pulmonary vein isolation). Participants will be randomly assigned to receive either the standard ablation alone or the ablation plus renal denervation. This trial suits individuals planning their first AF ablation, who have high blood pressure, and are open to follow-up visits. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future treatment options.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, since it mentions a history of hypertension and the use of antihypertensive medication as part of the inclusion criteria, it seems likely that you can continue those medications. It's best to discuss this with the trial coordinators for specific guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining renal denervation (RDN) with catheter ablation can safely treat atrial fibrillation (AF), a type of irregular heartbeat. In studies, patients receiving both treatments experienced fewer AF recurrences compared to those undergoing only the usual procedure, pulmonary vein isolation. Notably, adding RDN did not increase side effects. This suggests that combining these treatments is generally well-tolerated and may improve outcomes for some patients.12345
Why are researchers excited about this trial's treatments?
Unlike the standard treatment for atrial fibrillation, which typically involves catheter ablation alone, the investigational approach combines catheter ablation with renal denervation. This combination is unique because it not only targets the heart to disrupt abnormal electrical signals but also addresses the autonomic nervous system by modifying the renal nerves, which may help reduce blood pressure and stabilize heart rhythms more effectively. Researchers are excited about this novel approach as it holds the potential to enhance the success rate of atrial fibrillation treatment by tackling the condition through multiple mechanisms simultaneously.
What evidence suggests that this trial's treatments could be effective for Atrial Fibrillation?
Research shows that catheter ablation, one of the treatments in this trial, can effectively reduce the recurrence of atrial fibrillation (AF), a type of irregular heartbeat. One study found a 48% decrease in AF recurrence over four years. Another study reported that after one to four ablation procedures, 67% of patients no longer experienced irregular heartbeats.
In this trial, some participants will receive both catheter ablation and renal denervation. Research suggests that renal denervation may improve outcomes for AF patients with high blood pressure. A review of several studies has found that adding renal denervation to standard treatment can lead to better results for those with a history of high blood pressure. Additionally, renal denervation can lower nerve activity in the heart, which might help reduce AF episodes.678910Who Is on the Research Team?
Vivek Reddy, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Are You a Good Fit for This Trial?
This trial is for adults over 18 with a history of high blood pressure and planned first-ever AF ablation procedure. They must be willing to follow the study plan and have controlled hypertension, either Stage III or on medication. Excluded are those with long-term persistent AF, severe heart failure, poor kidney function, known allergies to contrast media not treatable, pregnant or nursing women, single functioning kidney individuals, drug/alcohol dependency issues, concurrent enrollment in conflicting trials.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo AF ablation with or without renal sympathetic denervation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Catheter Ablation
- Renal Denervation
Catheter Ablation is already approved in European Union, United States, Canada for the following indications:
- Symptomatic paroxysmal or persistent atrial fibrillation
- Heart failure with reduced left ventricular fraction
- Symptomatic paroxysmal or persistent atrial fibrillation
- Heart failure with reduced left ventricular fraction
- Symptomatic paroxysmal or persistent atrial fibrillation
- Heart failure with reduced left ventricular fraction
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vivek Reddy
Lead Sponsor