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

December 17, 2009
May 23, 2011
January 2009
June 2012   (final data collection date for primary outcome measure)
Echocardiographic reverse remodelling and dyssynchrony [ Time Frame: 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01035489 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Trial in Cardiac Resynchronization Therapy (CRT): Right Ventricular Apex Versus High Posterior Septum
Echocardiographic Dyssynchrony in Heart Failure in CRT; Right Ventricular Apex v.s. High Posterior Septum

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
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 apical lead placement
    Right ventricular apical lead placement in CRT
    Intervention: Device: CRT in heart failure; Right ventricular apex v.s. high posterior septum
  • Active Comparator: CRT; RV high posterior septum
    High posterior septal lead placement in CRT
    Intervention: Device: CRT in heart failure; Right ventricular apex v.s. high posterior septum

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
85
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01035489
2009/1991
No
Prof. Svein Faerestrand, Haukeland University Hospital, Dept. of Heart Disease, 5021 Bergen, Norway
Haukeland University Hospital
Not Provided
Principal Investigator: Svein Faerestrand, MD, PhD Faerestrand S
Haukeland University Hospital
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP