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
  Purpose

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.


Condition Intervention Phase
Atrioventricular Block
Other: Septal pacing
Other: His lead activated
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block

Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • Left ventricular ejection fraction (LVEF) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: September 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Septal pacing
Septal lead will be activated.
Other: Septal pacing
Septal lead activated
Other Name: Septal lead
Experimental: His-pacing
His lead will be activated 80 ms before septal lead
Other: His lead activated
His lead will be activated 80 ms before septal lead
Other Name: His lead

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019213

Locations
Denmark
Dept. of cardiology Skejby Hospital
AArhus, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital Skejby
Danish Heart Foundation
Investigators
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
  More Information

No publications provided

Responsible Party: Mads Brix Kronborg, Dr., Skejby Hospital
ClinicalTrials.gov Identifier: NCT01019213     History of Changes
Other Study ID Numbers: 07-4-B695-A1464-22378
Study First Received: November 23, 2009
Last Updated: May 14, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Aarhus University Hospital Skejby:
His-pacing

Additional relevant MeSH terms:
Atrioventricular Block
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014