NCT05313438

Brief Summary

The STIM-ADHF Study is a multi-center, observational study to assess the performance and safety of the CPNS System in patients with ADHF.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 10, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2023

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

March 29, 2022

Last Update Submit

November 7, 2023

Conditions

Acute Decompensated Heart Failure

Keywords

NeurostimulationContractilityRight Pulmonary Artery

Outcome Measures

Primary Outcomes (1)

  • Occurrence of related adverse events

    The following measures will be characterized in all enrolled subjects: occurrence of all procedure, device and therapy related adverse events, serious adverse events and deaths

    Enrolment to 30 Days post hospital discharge

Study Arms (1)

CPNS Therapy

EXPERIMENTAL

Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care.

Device: CPNS Therapy

Interventions

CPNS TherapyDEVICE

Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care

CPNS Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted to the hospital or planned to be admitted with a principal diagnosis of acute decompensated heart failure
  • BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL
  • LVEF ≤ 50%
  • At least one sign/symptom of fluid overload
  • At least one of the following:
  • Inadequate diuretic response
  • At least one sign or symptom of low perfusion

You may not qualify if:

  • Received an inotrope during current hospitalization
  • Requires mechanical support
  • Cardiogenic shock or impending cardiogenic shock
  • Multi-organ failure
  • Systolic blood pressure \< 80mmHg or \> 140mmHg
  • Symptomatic hypotension
  • eGFR \< 25 mL/min/1.732
  • Severe hepatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Semmelweis University, Heart and Vascular Center

Budapest, Hungary

Location

Hearth Faculty of Medicine, University of Pécs

Pécs, Hungary

Location

Szegedi Tudományegyetem ÁOK

Szeged, Hungary

Location

American Heart of Poland

Bielsko-Biala, Poland

Location

Stredoslovenský Ústav srdcových a Cievnych Chorȏb, a.s.

Banská Bystrica, 97401, Slovakia

Location

CINRE s.r.o

Bratislava, Slovakia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 6, 2022

Study Start

May 10, 2022

Primary Completion

September 12, 2023

Study Completion

September 12, 2023

Last Updated

November 8, 2023

Record last verified: 2023-11

Locations

HU(3)PL(1)SL(2)