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

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ClinicalTrials.gov Identifier: NCT01019213
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : May 15, 2012
Sponsor:
Collaborator:
Danish Heart Foundation
Information provided by (Responsible Party):
Mads Brix Kronborg, Aarhus University Hospital Skejby

Tracking Information
First Submitted Date  ICMJE November 23, 2009
First Posted Date  ICMJE November 25, 2009
Last Update Posted Date May 15, 2012
Study Start Date  ICMJE September 2007
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2012)
Left ventricular ejection fraction (LVEF) [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2009)
LVEF [ Time Frame: 12 months ]
Change History Complete list of historical versions of study NCT01019213 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2012)
  • 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 Measures  ICMJE
 (submitted: November 23, 2009)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block
Official Title  ICMJE 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 Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atrioventricular Block
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Kronborg MB, Mortensen PT, Poulsen SH, Gerdes JC, Jensen HK, Nielsen JC. His or para-His pacing preserves left ventricular function in atrioventricular block: a double-blind, randomized, crossover study. Europace. 2014 Aug;16(8):1189-96. doi: 10.1093/europace/euu011. Epub 2014 Feb 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 23, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01019213
Other Study ID Numbers  ICMJE 07-4-B695-A1464-22378
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mads Brix Kronborg, Aarhus University Hospital Skejby
Study Sponsor  ICMJE Aarhus University Hospital Skejby
Collaborators  ICMJE Danish Heart Foundation
Investigators  ICMJE
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
PRS Account Aarhus University Hospital Skejby
Verification Date May 2012

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