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Completed

NCT Number: NCT01019213

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.

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Key information

Conditions

Atrioventricular Block Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dept. of cardiology Skejby Hospital

Aarhus, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Septal pacing

Other

Septal lead activated

Other names: Septal lead

His lead activated

Other

His lead will be activated 80 ms before septal lead

Other names: His lead

Primary outcomes

  1. Left ventricular ejection fraction (LVEF)

    Time frame: 12 months

Secondary outcomes

  1. Quality of life

    Time frame: 12 months

  2. Synchrony by echocardiography

    Time frame: 12 months

  3. New York Heart Association (NYHA) class

    Time frame: 12

  4. 6-minute hall walk test

    Time frame: 12

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Collaborators

  • Danish Heart Foundation

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Nov 25, 2009
Registry last updated
May 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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