Epiphrenic III Pilot Trial

Luzerner Kantonsspital

Status: Unknown

Conditions: Heart Failure

Treatments: Device: Diaphragmatic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01837771

13008

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

25 participants in 2 patient groups

Diaphragmatic stimulation

Active Comparator group

Description:

Diaphragmatic stimulation via electrode for 4 weeks

Treatment:

Device: Diaphragmatic stimulation

No intervention

No Intervention group