Epiphrenic III Pilot Trial

NCT ID: NCT01837771

Last Updated: 2013-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Epiphrenic III Pilot Trial investigates whether a diaphragmatic stimulation by interventionally placed electrodes may improve heart function, symptoms and functional capacity in patients with severe heart failure.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diaphragmatic stimulation

Diaphragmatic stimulation via electrode for 4 weeks

Group Type ACTIVE_COMPARATOR

Diaphragmatic stimulation

Intervention Type DEVICE

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diaphragmatic stimulation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Symptomatic heart failure (NYHA functional classes II, III or IV)
* Reduced left ventricular ejection fraction (LVEF) \<35%
* Guideline-recommended drug therapy

Exclusion Criteria

* Patient refuses study participation
* Life expectancy presumably \<1 year
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Luzerner Kantonsspital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Paul Erne

Head of Department of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul Erne, MD

Role: PRINCIPAL_INVESTIGATOR

Luzerner Kantonsspital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, Switzerland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Paul Erne, MD

Role: CONTACT

++41 41 205 5208

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Paul Erne, MD

Role: primary

++41 41 205 5208

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13008

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The STIM-ADHF Study
NCT05313438 COMPLETED NA
Physiologic Pacing Registry
NCT03719040 COMPLETED
The REACT-ICD Trial
NCT02439424 UNKNOWN PHASE1/PHASE2
SynCardia Freedom Driver System Study
NCT00733447 APPROVED_FOR_MARKETING
The IMPULSE Study: Pilot
NCT02044471 COMPLETED NA