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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Aarhus University Hospital Skejby

Current Primary Outcome: Left ventricular ejection fraction (LVEF) [ Time Frame: 12 months ]

Original Primary Outcome: LVEF [ Time Frame: 12 months ]

Current Secondary Outcome:

  • Quality of life [ Time Frame: 12 months ]
  • Synchrony by echocardiography [ Time Frame: 12 months ]
  • New York Heart Association (NYHA) class [ Time Frame: 12 ]
  • 6-minute hall walk test [ Time Frame: 12 ]


Original Secondary Outcome:

  • Quality of life [ Time Frame: 12 months ]
  • Synchrony by echocardiography [ Time Frame: 12 months ]
  • NYHA class [ Time Frame: 12 ]
  • 6-minute hall walk test [ Time Frame: 12 ]


Information By: Aarhus University Hospital Skejby

Dates:
Date Received: November 23, 2009
Date Started: September 2007
Date Completion:
Last Updated: May 14, 2012
Last Verified: May 2012