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

Study acronym: Rebalance-HF
StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Trial sites expanded: 20 → 26 locations Show 4 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 15 entries
    • Publications: details revised at 44 of 45 entries
    • Study description expanded, about 5 words
  2. Enrollment target: 80 to 150v4 Show 10 more changesShow less
    • Primary completion date: Apr 2022 to Jan 10, 2028
    • Primary endpoints: 2 to 3
    • Study sites: 17 to 20
    • Study completion date: Mar 2023 to Aug 10, 2029
    • Interventions: Satera GSN Ablation (Device), Sham Control (Device) to Greater Splanchnic Nerve Ablation (Device), Sham Control (Device)
    • Eligibility criteria expanded, about 155 words
    • Secondary endpoints: 4 to 15
    • Study description expanded, about 354 words
    • Collaborators expanded, about 8 words
    • Publications: 2 to 45
  3. Study sites: 18 to 17
    • Primary completion date: Jan 2022 to Apr 2022
    • Study completion date: Jan 2023 to Mar 2023
    • Eligibility criteria expanded, about 35 words
    v3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Study sites: 0 to 18
    • Primary completion date: Jan 1, 2022 to Jan 2022
    • Study completion date: Jan 1, 2023 to Jan 2023
    • Start date changed from estimate of Jan 1, 2021 to Dec 18, 2020
    • Eligibility criteria expanded, about 63 words
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04592445
Lead Sponsor Axon Therapies, Inc.
Collaborators: NAMSA, Cardiovascular Research Foundation, New York, Northwestern University
Conditions
(from sponsor)		 Heart Failure With Preserved Ejection Fraction (HFpEF
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov