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

H

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)

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
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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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