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

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ClinicalTrials.gov Identifier: NCT01035489
Recruitment Status : Unknown
Verified May 2011 by Haukeland University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 18, 2009
Last Update Posted : May 24, 2011
Sponsor:
Information provided by:
Haukeland University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Heart Failure Device: CRT in heart failure; Right ventricular apex v.s. high posterior septum Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Echocardiographic Dyssynchrony in Heart Failure in CRT; Right Ventricular Apex v.s. High Posterior Septum
Study Start Date : January 2009
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Echocardiographic reverse remodelling and dyssynchrony [ Time Frame: 3, 6, 12, 18 and 24 months ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01035489


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Svein Faerestrand, Haukeland University Hospital, Dept. of Heart Disease, 5021 Bergen, Norway
ClinicalTrials.gov Identifier: NCT01035489     History of Changes
Other Study ID Numbers: 2009/1991
First Posted: December 18, 2009    Key Record Dates
Last Update Posted: May 24, 2011
Last Verified: May 2011

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases