Atrial Fibrillation (Paroxysmal)NCT07893821
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
A study testing Catheter-based renal artery electrical stimulation (as a feasibility assessment for renal denervation) in people with Atrial Fibrillation (Paroxysmal) and Hypertension, run by Pavel Antiperovitch at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (Paroxysmal), Hypertension, Heart Failure With Preserved Ejection Fraction (HFPEF)
- What is being tested?
- Catheter-based renal artery electrical stimulation (as a feasibility assessment for renal denervation)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2026to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Scheduled for EP study +/- catheter ablation
- Adequate renal function (eGFR ≥45 mL/min/1.73m²)
Who cannot join
- Hemodynamic instability
- Renal artery stenosis >50%
- Single functioning kidney
- Previous renal artery intervention
- Pregnancy or nursing
- Life expectancy <12 months
- Unwilling or unable to provide informed consent
- Participation in a clinical trial that may impact the outcomes of the current study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
London Heart Rhythm Program
London, Ontario, N6A5A5
About this study
Official title: A Pilot Study Evaluating Renal Denervation in Heart Failure Patients: A Two-Phase Prospective Study - Phase 1
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.
- Conditions
- Atrial Fibrillation (Paroxysmal), Hypertension, Heart Failure With Preserved Ejection Fraction (HFPEF)
- Being tested
- Catheter-based renal artery electrical stimulation (as a feasibility assessment for renal denervation)
- Keywords
- Renal Stimulation
- Medical subject headings
- Atrial Fibrillation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter-based renal artery electrical stimulation (as a feasibility assessment for renal denervation)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility of Renal Artery Cannulation and Stimulation | Other | There is no control group, placebo group, or comparator arm. All enrolled participants undergo the same study procedure during their scheduled VT/PVC ablation. Receives: Procedure: Catheter-based renal artery electrical stimulation (as a feasibility assessment for renal denervation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success Rate of Renal Artery Cannulationn
The proportion of patients in whom successful renal artery cannulation is achieved, as documented by the procedural operator. Technical success will be determined by successful catheter placement within the renal artery, allowing the planned procedure to proceed. Results will be reported as the number of successful cannulations divided by the total number of attempted cannulations, expressed as a percentage.
Measured: At the time of the procedure
Successful Delivery of Electrical Stimulation
The proportion of patients in whom electrical stimulation can be successfully delivered to the renal artery using the planned stimulation protocol.
Measured: At the time of the procedure
Change in Invasive Arterial Blood Pressure During Renal Artery Stimulation
The proportion of patients demonstrating a hypertensive response during renal artery stimulation, defined as an increase in systolic blood pressure of at least 10 mmHg compared with baseline, as measured using an arterial line
Measured: At the time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Aug 2026
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (Paroxysmal)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pavel Antiperovitch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pavel Antiperovitch, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893821
- Sponsor's protocol ID
- 127570
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating Renal Denervation in Heart Failure Patients: A Two-Phase Prospective Study - Phase 1
- ClinicalTrials.gov ID
- NCT07893821
- Acronym / sponsor ID
- 127570
- Conditions
- Atrial Fibrillation (Paroxysmal), Hypertension, Heart Failure With Preserved Ejection Fraction (HFPEF)
- Keywords
- Renal Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Pavel AntiperovitchUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility of Renal Artery Cannulation and Stimulation | Other | Procedure: Catheter-based renal artery electrical stimulation (as a feasibility assessment for renal denervation)There is no control group, placebo group, or comparator arm. All enrolled participants undergo the same study procedure during their scheduled VT/PVC ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Scheduled for EP study +/- catheter ablation
- Adequate renal function (eGFR ≥45 mL/min/1.73m²)
Key exclusion criteria (8 listed)
- Hemodynamic instability
- Renal artery stenosis >50%
- Single functioning kidney
- Previous renal artery intervention
- Pregnancy or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Feasibility of Renal Artery Cannulation and Stimulation |
Primary outcome
Technical Success Rate of Renal Artery Cannulationn
Time frame: At the time of the procedure
The proportion of patients in whom successful renal artery cannulation is achieved, as documented by the procedural operator. Technical success will be determined by successful catheter placement within the renal artery, allowing the planned procedure to proceed. Results will be reported as the number of successful cannulations divided by the total number of attempted cannulations, expressed as a percentage.
Successful Delivery of Electrical Stimulation
Time frame: At the time of the procedure
The proportion of patients in whom electrical stimulation can be successfully delivered to the renal artery using the planned stimulation protocol.
Change in Invasive Arterial Blood Pressure During Renal Artery Stimulation
Time frame: At the time of procedure
The proportion of patients demonstrating a hypertensive response during renal artery stimulation, defined as an increase in systolic blood pressure of at least 10 mmHg compared with baseline, as measured using an arterial line
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter-based renal artery electrical stimulation (as a feasibility assessment for renal denervation) in people with Atrial Fibrillation (Paroxysmal) and Hypertension, run by Pavel Antiperovitch at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Smith (519-685-8500 ext. 32490, meganj.smith@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success Rate of Renal Artery Cannulationn (time frame: At the time of the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.