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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. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Haukeland University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01035489
First Posted: December 18, 2009
Last Update Posted: May 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Haukeland University Hospital
  Purpose
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: None (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 ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

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 Submitted: December 17, 2009
First Posted: December 18, 2009
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