Trial in Cardiac Resynchronization Therapy (CRT): Right Ventricular Apex Versus High Posterior Septum

Haukeland University Hospital

Status and phase: Unknown; Phase 2

Conditions: Heart Failure

Treatments: Device: CRT in heart failure; Right ventricular apex v.s. high posterior septum

Study type: Interventional

Funder types: Other

Identifiers

NCT01035489

2009/1991

Details and patient eligibility

About

In heart failure patients we hypothesised that right ventricular high posterior septum is superior to right ventricular apex in CRT and DDD pacemaker. In two separate trials we prospectively randomized the right ventricular lead placement to find evidence of differences in heart failure symptoms (NYHA-class), 6 minute hall walk and echocardiographic measurements of reverse remodelling and dyssynchrony.

Enrollment: 85 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CRT:

  • LVEF < 35%
  • LVEDD > 5.5 cm
  • NYHA 3-4
  • QRS > 120 ms
  • Optimal medical treatment
  • Both CRT-pacemakers (CRT-P) and CRT combined with ICD (CRT-D)

Exclusion criteria

• Not fulfilling inclusion criteria or not written consensus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

CRT; RV apical lead placement

Active Comparator group

Description:

Right ventricular apical lead placement in CRT

Treatment:

Device: CRT in heart failure; Right ventricular apex v.s. high posterior septum

Device: CRT in heart failure; Right ventricular apex v.s. high posterior septum

CRT; RV high posterior septum

Active Comparator group

Description:

High posterior septal lead placement in CRT

Treatment:

Device: CRT in heart failure; Right ventricular apex v.s. high posterior septum

Device: CRT in heart failure; Right ventricular apex v.s. high posterior septum