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Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)

Study acronym: NECTAR-HF
StatusActive, Not Recruiting
PhaseNot applicable
Started2011-09-21
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 59 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-07-23
Study Status v58
Completion pushed: 2026-06-30 → 2027-06-30
2026-06-26
7 amendments v51-v57
7 re-verifications since 2025-11-18, no change to tracked fields
2025-09-25
Study Status v50
Completion date2025-06-30→2026-06-30
2025-05-21
5 amendments v45-v49
5 re-verifications since 2024-07-01, no change to tracked fields
2024-05-29
Study Status v44
Completion date2024-06-30→2025-06-30
Show 35 earlier versions
2024-04-25
11 amendments v33-v43
11 re-verifications since 2023-01-26, no change to tracked fields
2022-12-20
Study Status v32
Completion date2023-12-30→2024-06-30
2022-10-31
4 amendments v28-v31
4 re-verifications since 2022-08-01, no change to tracked fields
2022-02-28
Study Status v27
Completion date2022-12-30→2023-12-30
2022-01-24
Study Status, Study Design v26
Completion date2022-06-30→2022-12-30
2021-01-11
Study Status, References v25
Completion date2021-06-30→2022-06-30
Publications2 to 3 entries
De Ferrari GM, Stolen C, Tuinenburg AE, Wright DJ, Brugada J, Butter C, Klein H, Neuzil P, Botman C, Castel MA, D'Onofrio A, de Borst GJ, Solomon S, Stein KM, Schubert B, Stalsberg K, Wold N, Ruble S, Zannad F. Long-term vagal stimulation for heart failure: Eighteen month results from the NEural Car [...]
2020-01-22
Study Status v24
Re-verified, no change to tracked fields
2019-12-16
Study Status, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations, IPDSharing, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats, More Information v23
PhasePhase 2→Not applicable
Primary completion dateestimated 2017-05→confirmed 2014-05
Completion date2018-01→2021-06-30
Start date2011-06→2011-09-21
Results first postednot stated→2020-01-06
Enrollment targetestimated 250→confirmed 118
InterventionsVagal Nerve Stimulation (Device)→Blood Draw (Diagnostic Test), Implant of investigational device system (Device), Titration after the randomization phase (Procedure)…
Secondary endpoints4 to 3 entries
LVEF, Left ventricularVentricular remodelingEjection Fraction FunctionalExercise capacityCapacity, Peak VO2 QualityLVESV, ofLeft Life HeartVentricular failureEnd statusSystolic Volume
Primary endpoints2 entries, revised
All-causeChange mortality in Left ventricularVentricular endEnd-systolic dimensionDimension (LVESD) Percentage of Surviving Participants
Study sitesdetails revised at 3 of 21 sites
2015-11-23
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v22
Trial statusRecruiting→Active, Not Recruiting
Study sites24→21
2015-07-31
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations, References v21
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2014-01→2017-05
Completion date2015-01→2018-01
Study sitesdetails revised at 24 of 24 sites
2013-12-19
Study Status, Conditions, Eligibility v20
Eligibility criteria+416 characters
[...] l investigation Stable symptomatic heart failure NYHA class II-III Left ventricular (LV) ejection fraction equal or smaller [...] nts with persistent or permanent atrial fibrillation within 18090 days prior to enrollment Pacemaker indicated patients Patie [...] e heart failure is due to congenital heart disease Patients activelywho treatedhave started treatment for sleep apnea or sleep disordered breathing with therapies to maintain airway patency (e.g., CPAP, Bi-PAP,APAP) with or without oxygen supplementation within the previous 6 months prior to enrollment Patients with hypertrophic obstructive cardiomyo [...] [...]
2013-07-25
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v19
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2013-12→2014-01
Completion date2015-12→2015-01
Study sitesdetails revised at 24 of 24 sites
2012-10-15
Study Status, Contacts/Locations v18
Study sites23→24
2012-09-25
Study Status, Contacts/Locations v17
Study sites21→23
2012-08-13
Study Status, Contacts/Locations v16
Study sites20→21
2012-08-08
Study Status, Contacts/Locations v15
Study sites19→20
2012-06-27
Study Status, Contacts/Locations v14
Study sites19 entries, revised
Evangelisch-FreikirchlichesImmanuel KrankenhausKlinikum undBernau Herzzentrum Brandenburg in Bernau Clínica UniversidadUniversitaria de Navarra, Avenida Pio XII s/n
2012-06-26
Study Status, Contacts/Locations v13
Study sites18→19
2012-06-12
Study Status, Contacts/Locations v12
Study sites17→18
2012-06-11
Study Status, Contacts/Locations v11
Study sites16→17
2012-06-08
Study Status, Contacts/Locations v10
Study sites14→16
2012-01-25
Study Status, Contacts/Locations v9
Study sites13→14
The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms.
Trial Details
NCT Number NCT01385176
Lead Sponsor Boston Scientific Corporation
Conditions Heart Failure, Congestive Heart Failure
Enrollment 118 participants
Start Date 2011-09-21
Primary Completion 2014-05 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-25