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

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
CRT in heart failure; Right ventricular apex v.s. high posterior septum
CRT in heart failure; Right ventricular apex v.s. high posterior septum
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Pacemaker treatment in heart failure, Cardiac resynchronization therapy, DDD pacemakers

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CRT; RV apical lead placement

CRT; RV high posterior septum

Arm Description

Right ventricular apical lead placement in CRT

High posterior septal lead placement in CRT

Outcomes

Primary Outcome Measures

Echocardiographic reverse remodelling and dyssynchrony

Secondary Outcome Measures

Full Information

First Posted
December 17, 2009
Last Updated
May 23, 2011
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01035489
Brief Title
Trial in Cardiac Resynchronization Therapy (CRT): Right Ventricular Apex Versus High Posterior Septum
Official Title
Echocardiographic Dyssynchrony in Heart Failure in CRT; Right Ventricular Apex v.s. High Posterior Septum
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Haukeland University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Pacemaker treatment in heart failure, Cardiac resynchronization therapy, DDD pacemakers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CRT; RV apical lead placement
Arm Type
Active Comparator
Arm Description
Right ventricular apical lead placement in CRT
Arm Title
CRT; RV high posterior septum
Arm Type
Active Comparator
Arm Description
High posterior septal lead placement in CRT
Intervention Type
Device
Intervention Name(s)
CRT in heart failure; Right ventricular apex v.s. high posterior septum
Intervention Description
RV lead is randomized to either apex or high posterior septum
Intervention Type
Device
Intervention Name(s)
CRT in heart failure; Right ventricular apex v.s. high posterior septum
Intervention Description
RV lead is randomized to either apex or high posterior septum
Primary Outcome Measure Information:
Title
Echocardiographic reverse remodelling and dyssynchrony
Time Frame
3, 6, 12, 18 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svein Faerestrand, MD, PhD
Organizational Affiliation
Faerestrand S
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
22677455
Citation
Kristiansen HM, Vollan G, Hovstad T, Keilegavlen H, Faerestrand S. The impact of left ventricular lead position on left ventricular reverse remodelling and improvement in mechanical dyssynchrony in cardiac resynchronization therapy. Eur Heart J Cardiovasc Imaging. 2012 Dec;13(12):991-1000. doi: 10.1093/ehjci/jes114. Epub 2012 Jun 7.
Results Reference
derived
PubMed Identifier
22308084
Citation
Kristiansen HM, Hovstad T, Vollan G, Keilegavlen H, Faerestrand S. Clinical implication of right ventricular to left ventricular interlead sensed electrical delay in cardiac resynchronization therapy. Europace. 2012 Jul;14(7):986-93. doi: 10.1093/europace/eur429. Epub 2012 Feb 2.
Results Reference
derived
PubMed Identifier
22286156
Citation
Kristiansen HM, Vollan G, Hovstad T, Keilegavlen H, Faerestrand S. A randomized study of haemodynamic effects and left ventricular dyssynchrony in right ventricular apical vs. high posterior septal pacing in cardiac resynchronization therapy. Eur J Heart Fail. 2012 May;14(5):506-16. doi: 10.1093/eurjhf/hfr162. Epub 2012 Jan 26.
Results Reference
derived

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

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