Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF

Conditions

• Heart Failure With Preserved Ejection Fraction (HFpEF

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Greater Splanchnic Nerve Ablation — DEVICE
  The greater splanchnic nerve (GSN) ablation procedure begins with a small needle puncture in the groin or neck to access a vein, using methods that are commonly used for heart procedures. Doctors then guide thin tubes and wires through the vein to reach a nerve called the right greater splanchnic nerve. X-ray imaging is used to help the doctor see where the catheter is and guide it to the correct location. Once the catheter is in the right place, the doctor uses the device to treat the nerve using controlled heat.
• Sham Control — DEVICE
  During the sham procedure, a small needle puncture will be made in the groin or neck to access a vein using standard medical techniques. A short tube will be placed into the vein, similar to what is done for many heart procedures. The Satera catheter and treatment devices will not be inserted, and the nerve will not be treated. The procedure will take about the same amount of time as the treatment procedure.

Study Details

The purpose of this clinical study is to evaluate the safety and early effectiveness of a catheter-based procedure that treats a nerve called the right greater splanchnic nerve. The study includes people who have heart failure with preserved ejection fraction (HFpEF). The goal is to learn whether this procedure, performed using the Satera Ablation System, may help improve symptoms and to better understand which patients may benefit most from this treatment in the future.

Key Dates

Start date

Dec 18, 2020

Status verified

Mar 2026

Primary completion

Jan 10, 2028

Completion

Aug 10, 2029

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Greater Splanchnic Nerve Ablation
  After anesthesia is given, doctors will use the Satera Ablation System to reach a nerve called the right greater splanchnic nerve. Subjects receive catheter-based unilateral ablation of the right greater splanchnic nerve.
• Sham Comparator: Sham Control Arm
  After anesthesia is given, doctors will place a small tube into a vein. The steps and length of the procedure will be similar to the Axon treatment procedure, but the study treatment will not be performed.

Primary Outcome Measure

Primary Safety Endpoint: Device or procedure related serious adverse events [ Time Frame: 1 Month ]

Central Contacts

• Judit Adorjan
  16507221119
  [email protected]
• Jennifer Moore, MS
  [email protected]

Locations (20)

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