Recruiting

Renal Denervation

Sponsor:

Pavel Antiperovitch

Code:

NCT07893821

Conditions

Atrial Fibrillation (Paroxysmal)

Hypertension

Heart Failure With Preserved Ejection Fraction (HFPEF)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Catheter-based renal artery electrical stimulation (as a feasibility assessment for renal denervation)

Study Details

Brief 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. 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)

Study ID

NCT07893821

Start date

Aug 1, 2026

Status verified date

Oct, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥18 years
2. Scheduled for EP study +/- catheter ablation
3. Adequate renal function (eGFR ≥45 mL/min/1.73m²)

Exclusion Criteria:

1. Hemodynamic instability
2. Renal artery stenosis >50%
3. Single functioning kidney
4. Previous renal artery intervention
5. Pregnancy or nursing
6. Life expectancy <12 months
7. Unwilling or unable to provide informed consent
8. Participation in a clinical trial that may impact the outcomes of the current study

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Feasibility of Renal Artery Cannulation and Stimulation

There is no control group, placebo group, or comparator arm. All enrolled participants undergo the same study procedure during their scheduled VT/PVC ablation.

Interventions

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.

Primary outcome measure

  • Technical Success Rate of Renal Artery Cannulationn [ Time Frame: At the time of the procedure ]
  • Successful Delivery of Electrical Stimulation [ Time Frame: At the time of the procedure ]
  • Change in Invasive Arterial Blood Pressure During Renal Artery Stimulation [ Time Frame: At the time of procedure ]

Central Contacts and Locations

Central contacts

Megan Smith

519-685-8500meganj.smith@lhsc.on.ca

Locations

London Heart Rhythm Program

Recruiting

London, Ontario, Canada, N6A5A5

More Information

Sponsor

Pavel Antiperovitch

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Keywords

  • Renal Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Pavel Antiperovitch on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.