Testing Catheter-based renal artery electrical for atrial fibrillation (paroxysmal)
Official title: Renal Denervation in Patients With Atrial Fibrillation and Hypertension
A Pilot Study Evaluating Renal Denervation in Heart Failure Patients: A Two-Phase Prospective Study - Phase 1
- 1 group
- One site, in London
- Recruiting
Interventions
- Medical procedure
Catheter-based renal artery electrical stimulation (as a feasibility assessment for renal denervation)
During a scheduled EP study ± VT/PVC ablation: Renal arteries are selectively visualized with angiography. The ablation catheter is advanced into each renal artery. Electrical stimulation is delivered: 10 V, 0.4 ms pulse width, 100 ms cycle length, 30 seconds per renal artery Blood pressure response is measured through arterial monitoring. A positive response is defined as ≥10 mmHg increase in systolic blood pressure.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
London Heart Rhythm Program
London, Ontario
Eligibility Criteria
See who this study is looking for11 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥18 years
- +Adequate renal function (eGFR ≥45 mL/min/1.73m²)
- +Scheduled for EP study +/- catheter ablation
Exclusion
- −Hemodynamic instability
- −Renal artery stenosis \>50%
- −Single functioning kidney
- −Previous renal artery intervention
- −Life expectancy \<12 months
- −Unwilling or unable to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −Participation in a clinical trialInterventional studyA study where participants are given something to see what happens.Read more → that may impact the outcomes of the current study
- −Pregnancy or nursing
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Catheter-based renal artery electrical stimulation (as a feasibility assessment for renal denervation).
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 10 people.
The study is currently expected to finish around August 2029.
The main measurement is taken over: At the time of the procedure.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Technical Success Rate of Renal Artery Cannulationn — measured over At the time of the procedure.
Successful Delivery of Electrical Stimulation — measured over At the time of the procedure.
Change in Invasive Arterial Blood Pressure During Renal Artery Stimulation — measured over At the time of procedure.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07893821 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Catheter-based renal artery electrical stimulation (as a feasibility assessment for renal denervation)Procedure
During a scheduled EP study ± VT/PVC ablation: Renal arteries are selectively visualized with angiography. The ablation catheter is advanced into each renal artery. Electrical stimulation is delivered: 10 V, 0.4 ms pulse width, 100 ms cycle length, 30 seconds per renal artery Blood pressure response is measured through arterial monitoring. A positive response is defined as ≥10 mmHg increase in systolic blood pressure.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: At the time of the procedure.
The study as a whole is currently expected to finish around 2029-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 10 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: London, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
High blood pressure is a major risk factor for atrial fibrillation (AF), an irregular heart rhythm, and heart failure with preserved ejection fraction (HFpEF), a condition in which the heart becomes stiff and cannot relax properly. Both conditions can significantly affect quality of life and frequently occur together. In individuals with high blood pressure, increased activity of the nerves surrounding the kidneys can further elevate blood pressure and contribute to strain on the heart. Renal denervation (RDN) is a procedure designed to lower blood pressure by reducing the activity of these nerves using a thin catheter and controlled energy. RDN has been shown to lower blood pressure safely in many patients; however, the potential benefits in individuals with concurrent AF and HFpEF remain uncertain. This pilot study will be conducted in two phases. Phase 1 will assess the safety and feasibility of accessing the renal arteries and evaluating blood pressure responses to brief electrical stimulation of the renal nerves.
If this study interests you
Three things you can do from here. None of them commits you to anything.
Save it to your Collection
Keep it with the other studies you are looking at.
Share it with your doctor
Send the study to your own clinician to talk through together.
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Or answer a few questions to see which studies in Canada are closest to what you described.
This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.