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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Haukeland University Hospital.
Recruitment status was  Active, not recruiting
Information provided by:
Haukeland University Hospital Identifier:
First received: December 17, 2009
Last updated: May 23, 2011
Last verified: May 2011

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.

Condition Intervention Phase
Heart Failure
Device: CRT in heart failure; Right ventricular apex v.s. high posterior septum
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Echocardiographic Dyssynchrony in Heart Failure in CRT; Right Ventricular Apex v.s. High Posterior Septum

Resource links provided by NLM:

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Echocardiographic reverse remodelling and dyssynchrony [ Time Frame: 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 85
Study Start Date: January 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CRT; RV apical lead placement
Right ventricular apical lead placement in CRT
Device: CRT in heart failure; Right ventricular apex v.s. high posterior septum
RV lead is randomized to either apex or high posterior septum
Active Comparator: CRT; RV high posterior septum
High posterior septal lead placement in CRT
Device: CRT in heart failure; Right ventricular apex v.s. high posterior septum
RV lead is randomized to either apex or high posterior septum


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01035489

Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Principal Investigator: Svein Faerestrand, MD, PhD Faerestrand S
  More Information

No publications provided by Haukeland University Hospital

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Svein Faerestrand, Haukeland University Hospital, Dept. of Heart Disease, 5021 Bergen, Norway Identifier: NCT01035489     History of Changes
Other Study ID Numbers: 2009/1991
Study First Received: December 17, 2009
Last Updated: May 23, 2011
Health Authority: Norway: Ethics Committee

Keywords provided by Haukeland University Hospital:
Pacemaker treatment in heart failure
Cardiac resynchronization therapy
DDD pacemakers

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases processed this record on February 27, 2015