250 Participants Needed

Renal Denervation for Atrial Fibrillation

Recruiting at 7 trial locations
JL
BE
Overseen ByBetsy Ellsworth, MSN ANP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vivek Reddy
Must be taking: Antihypertensives
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This is a Prospective, controlled, single-blind, randomized (2:1, Intervention:Control) clinical trial. The purpose of the study is to determine the role of adjunctive renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension scheduled for a redo AF ablation procedure for paroxysmal or persistent AF. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves patients with hypertension who are already on antihypertensive medication, it seems likely that you may continue your current medications.

What data supports the effectiveness of the treatment Renal Denervation for Atrial Fibrillation?

Research shows that Pulmonary Vein Isolation (PVI), a key part of catheter ablation, is effective in managing atrial fibrillation by helping restore and maintain a normal heart rhythm. This suggests that the treatment, which includes PVI, may be effective for atrial fibrillation.12345

Is renal denervation safe for humans?

Pulmonary vein isolation (PVI), a type of catheter ablation, is generally considered safe, with severe complications occurring in 1-3% of patients. This suggests that similar procedures like renal denervation may also have a comparable safety profile.13567

How does the treatment Catheter Ablation for Atrial Fibrillation differ from other treatments for this condition?

Catheter Ablation, specifically Pulmonary Vein Isolation (PVI), is unique because it targets the electrical signals in the heart by isolating the pulmonary veins, which is a cornerstone strategy for rhythm control in atrial fibrillation. Unlike medications, this treatment directly modifies the heart's electrical pathways to restore normal rhythm.13458

Research Team

Vivek Reddy, MD - Physician's Channel ...

Vivek Reddy, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

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.

Inclusion Criteria

I have high blood pressure or am on medication for it.
I am 18 years old or older.
Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
See 1 more

Exclusion 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.
See 27 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either catheter ablation alone or catheter ablation with renal sympathetic denervation

Expected to take 6 months to set up clinical sites and 9 months for accrual

Follow-up

Participants are monitored for safety and effectiveness after treatment, including freedom from atrial arrhythmias and quality of life assessments

12 months

Treatment Details

Interventions

  • Catheter Ablation
  • Renal Denervation
Trial OverviewThe 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.
Participant Groups
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

Catheter Ablation is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Pulmonary Vein Isolation (PVI) for:
  • Symptomatic paroxysmal or persistent atrial fibrillation
  • Heart failure with reduced left ventricular fraction
🇺🇸
Approved in United States as Pulmonary Vein Isolation (PVI) for:
  • Symptomatic paroxysmal or persistent atrial fibrillation
  • Heart failure with reduced left ventricular fraction
🇨🇦
Approved in Canada as Pulmonary Vein Isolation (PVI) for:
  • 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

Trials
23
Recruited
5,700+

Findings from Research

The novel irrigated multielectrode ablation catheter successfully isolated 100% of targeted pulmonary veins in 25 patients with paroxysmal atrial fibrillation, demonstrating high acute efficacy with a mean procedure time of 110 minutes and no complications.
The procedure was safe, with no cases of acute pulmonary vein stenosis detected, and showed improved efficiency over time, with reduced procedure and fluoroscopy times after a short learning curve.
Initial results of using a novel irrigated multielectrode mapping and ablation catheter for pulmonary vein isolation.Shin, DI., Kirmanoglou, K., Eickholt, C., et al.[2016]
In a study of 486 patients with persistent and long-standing persistent atrial fibrillation (AF) treated with cryoballoon ablation, the procedure demonstrated a high acute success rate of 97.6% for pulmonary vein isolation (PVI).
The procedure was found to be safe, with a low complication rate of 4.3%, and showed reasonable mid-term success rates for freedom from AF, with 63.9% of patients remaining event-free at 12 months.
Pulmonary vein isolation cryoablation for patients with persistent and long-standing persistent atrial fibrillation: Clinical outcomes from the real-world multicenter observational project.Tondo, C., Iacopino, S., Pieragnoli, P., et al.[2018]
The STOP Persistent AF trial showed that cryoballoon ablation is a safe and effective treatment for patients with drug-refractory persistent atrial fibrillation, achieving a 54.8% success rate in maintaining freedom from AF, AFL, or AT at 12 months.
With only one primary safety event reported (0.6% rate), the procedure demonstrated a favorable safety profile, alongside significant improvements in quality of life as measured by the AFEQT and SF-12 questionnaires.
Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial.Su, WW., Reddy, VY., Bhasin, K., et al.[2021]

References

Initial results of using a novel irrigated multielectrode mapping and ablation catheter for pulmonary vein isolation. [2016]
Pulmonary vein isolation cryoablation for patients with persistent and long-standing persistent atrial fibrillation: Clinical outcomes from the real-world multicenter observational project. [2018]
Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial. [2021]
Innovations in atrial fibrillation ablation. [2023]
Comparative effectiveness of catheter ablation strategies for rhythm control in patients with atrial fibrillation: a meta-analysis. [2021]
Complications in pulmonary vein isolation in the Netherlands Heart Registration differ with sex and ablation technique. [2021]
A new circular mapping-guided approach for endoscopic laser balloon pulmonary vein isolation. [2020]
Efficacy of multi-electrode duty-cycled radiofrequency ablation in patients with paroxysmal and persistent atrial fibrillation. [2022]