Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block

This study has been completed.
Sponsor:
Collaborator:
Danish Heart Foundation
Information provided by (Responsible Party):
Mads Brix Kronborg, Skejby Hospital
ClinicalTrials.gov Identifier:
NCT01019213
First received: November 23, 2009
Last updated: May 14, 2012
Last verified: May 2012

November 23, 2009
May 14, 2012
September 2007
September 2011   (final data collection date for primary outcome measure)
Left ventricular ejection fraction (LVEF) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
LVEF [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01019213 on ClinicalTrials.gov Archive Site
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Synchrony by echocardiography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • New York Heart Association (NYHA) class [ Time Frame: 12 ] [ Designated as safety issue: No ]
  • 6-minute hall walk test [ Time Frame: 12 ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Synchrony by echocardiography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • NYHA class [ Time Frame: 12 ] [ Designated as safety issue: No ]
  • 6-minute hall walk test [ Time Frame: 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block
Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block

Conventional right ventricular (RV) apical pacing may result in asynchronous ventricular contraction with delayed left ventricular activation, interventricular motion abnormalities, and worsening of left ventricular ejection fraction. His pacing is preserving a synchronous contraction and may prevent a decrease in left ventricular ejection fraction.

Hypothesis: His-pacing preserves left ventricular function and is a feasable alternative compared to RV septal septal pacing in patients with AV-block.

Conventional right ventricular apical pacing may result in asynchronous ventricular contraction with delayed left ventricular activation, interventricular motion abnormalities, and worsening of left ventricular ejection fraction. His pacing is preserving a synchronous contraction and may prevent a decrease in left ventricular ejection fraction.

The aims of our crossover, double-blinded, randomized study is to evaluate the feasibility and long-term safety of permanent His pacing and to compare the effects on left ventricular ejection fraction of permanent His pacing with those of conventional right septal stimulation after 12 months treatment in patients with 2nd or 3rd degree AV-block.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Atrioventricular Block
  • Other: Septal pacing
    Septal lead activated
    Other Name: Septal lead
  • Other: His lead activated
    His lead will be activated 80 ms before septal lead
    Other Name: His lead
  • Placebo Comparator: Septal pacing
    Septal lead will be activated.
    Intervention: Other: Septal pacing
  • Experimental: His-pacing
    His lead will be activated 80 ms before septal lead
    Intervention: Other: His lead activated
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 2nd or 3rd degree Av block

Exclusion Criteria:

  • QRS > or = 120 ms
  • Indication for cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD)
  • chronic atrial fibrillation
  • Pregnant
  • Expected heart surgery < 2 years
  • Expected survival > 2 years
  • Patients that have been His ablated
  • Serious comorbidity
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01019213
07-4-B695-A1464-22378
No
Mads Brix Kronborg, Skejby Hospital
Skejby Hospital
Danish Heart Foundation
Study Chair: Torsten T Nielsen, Professor Dept. B Skejby Hospital
Study Chair: Jens C Nielsen, Phycisian Aarhus university Hospital Skajby
Principal Investigator: Mads B Kronborg, Phycisian Aarhus University Hospital Skejby
Aarhus University Hospital Skejby
May 2012

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