CLINICAL TRIAL

renal denervation for Atrial Fibrillation

Recruiting · 18+ · All Sexes · Prague, Czechia

Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation

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About the trial for Atrial Fibrillation

Treatment Groups

This trial involves 2 different treatments. Renal Denervation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
renal denervation
DEVICE
Catheter ablation
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Catheter ablation
DEVICE

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
renal denervation
2011
N/A
~60
Catheter ablation
2016
Completed Phase 4
~710

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The first-ever AF ablation procedure must have been completed successfully before randomization. show original
is critical to the success of any study show original
Age ≥ 18 years of age;
history of hypertension, diabetes mellitus, or prior MI SBP≥160 or DBP≥100 or; history of hypertension, diabetes mellitus, or prior MI is a documented history. show original
56% Approximately 56% of people who take antihypertensive medications receive only one. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether renal denervation will improve 1 primary outcome and 6 secondary outcomes in patients with Atrial Fibrillation. Measurement will happen over the course of 30 days.

Rate of procedural adverse events
30 DAYS
Rate of procedural adverse events
30 DAYS
AF burden at 6 months
6 MONTHS
AF burden at 6 months
6 MONTHS
Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds
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.
12 MONTHS
Change in office systolic blood pressure change from baseline to 12 months
12 MONTHS
Change in office systolic blood pressure change from baseline to 12 months
12 MONTHS
AF burden at 12 months
12 MONTHS
AF burden at 12 months
12 MONTHS
The Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire
12 MONTHS
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.
12 MONTHS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is atrial fibrillation?

Results from a recent paper, the mean age of our patient population was 62.6 years, and the mean ejection fraction was 59.7% (male: 57.4%, female: 60.4%). Mean LA diameter was 38.1 mm. The left atrium (LA) was larger in females than in males (P = 0.026) (48.9 vs. 42.1 mm, respectively). In patients with AF, the mean LA diameter was larger than in the control group (P = 0.004). In addition, the LA volume in men was higher (P = 0.004) than in women (P = 0.045).

Anonymous Patient Answer

What are common treatments for atrial fibrillation?

Patients with AF are more likely to be elderly. They have higher rates of diabetes and hypertension compared to those with SR. Most AF patients were treated with anti-arrhythmic agents, but those with chronic AF less often received β-blockers. AF is frequently treated with a combination of medical and surgical approaches but this depends on the severity of symptoms and lifestyle of individual patients.

Anonymous Patient Answer

What are the signs of atrial fibrillation?

It is crucial to know the main symptom of AF (irregular heart beat) and the associated risk factors when diagnosing AF. In conjunction to electrocardiography, clinical information of AF is of extreme utility in assessing the most serious risk of AF.

Anonymous Patient Answer

How many people get atrial fibrillation a year in the United States?

Data from a recent study suggest that atrial fibrillation is relatively common, occurring in approximately 1 in 500 adults. In contrast, AF was comparatively rare among older patients. Data from a recent study suggest that AF represents a new public health issue. Identifying risk factors, modifying lifestyle and medication strategies, and implementing effective systems of management may help reduce the burden of AF in the future.

Anonymous Patient Answer

Can atrial fibrillation be cured?

AF is a debilitating disease as well as a major health problem. Given the many options available and advances in cardioversion and catheter ablation, long-term AF termination is a possible goal for the future. There is a long-standing and compelling need for high quality data to guide this endeavor.

Anonymous Patient Answer

What causes atrial fibrillation?

Atrial fibrillation is the most common arrhythmia in adults. Its incidence rises exponentially with age and is much higher in males than females. Cardiac factors account for only a minority of cases. The cause of atrial fibrillation is not entirely determined. It is well known that viral infections (parvovirus B19 and human parvovirus B19) can cause heart block and cardiac arrhythmia by activating the parasympathetic nervous system.

Anonymous Patient Answer

Does atrial fibrillation run in families?

AF may run in families. Results from a recent clinical trial suggests that atrial fibrillation is under-diagnosed in families with a history of AF. The higher risk for AF in couples may result in earlier diagnosis of AF in those affected and more effective management.

Anonymous Patient Answer

Have there been other clinical trials involving renal denervation?

We present data indicating that kidney denervation can be achieved with minimal complications in selected patients and that these complications can be reversed. The presence of renal impairment may be a determinant of nonresponse after renal-denervation therapy, highlighting the need for further research.

Anonymous Patient Answer

How does renal denervation work?

Renal denervation in rabbits significantly reduces the generation of atrial fibrillation in a manner similar to how it reduces AF in humans. Further study of the effects of renal denervation in humans with AF is warranted.

Anonymous Patient Answer

What does renal denervation usually treat?

RDN was significantly associated with a reduced risk of death in patients with heart failure. Recent findings support the use of RDN as the treatment of choice for heart failure.

Anonymous Patient Answer

Does renal denervation improve quality of life for those with atrial fibrillation?

This proof-of-concept study in a real-world population suggests that RDN may improve HRQOL in those with AF. As this study was uncontrolled, we recommend it be performed under a randomised protocol before any clinical trials. These data suggest that RDN is potentially a viable option for HRQOL improvement for AF.

Anonymous Patient Answer

Have there been any new discoveries for treating atrial fibrillation?

There have not been any new medications approved for the treatment of symptomatic or asymptomatic atrial fibrillation, and no specific biomarkers have been developed for this patient population. Continued studies into biomarkers of the condition are needed to identify individuals with a high likelihood for developing the condition who require more urgent treatment, and to identify those who may respond to newer therapeutic strategies.

Anonymous Patient Answer
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