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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
Sponsor:
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01035489
First received: December 17, 2009
Last updated: May 23, 2011
Last verified: May 2011
History of Changes
  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: 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:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Haukeland University Hospital

Additional 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
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
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013