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Minimizing Ventricular Pacing

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Military Institute of Medicine, Poland.
Recruitment status was:  Recruiting
Information provided by:
Military Institute of Medicine, Poland Identifier:
First received: May 31, 2012
Last updated: June 4, 2012
Last verified: May 2012
The aim of this study is to evaluate the effect of minimizing right ventricular pacing in dual-chamber pacemaker patients with sinus node disease (SND) and first degree atrioventricular block (AVIB)on exercise capacity, quality of life and other heart failure measures.

Condition Intervention
Sinus Node Disease.
First Degree Atrioventricular Block.
Device: Prolonging atrioventricular (AV) delay.
Device: Standard atrioventricular (AV) delay.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Minimizing Right Ventricular Pacing in Dual-chamber Pacemaker Patients With Sinus Node Disease and First Degree Atrioventricular Block.

Resource links provided by NLM:

Further study details as provided by Military Institute of Medicine, Poland:

Primary Outcome Measures:
  • Oxygen uptake (cardiopulmonary exercise testing). [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Left ventricular ejection fraction. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Assessed in echocardiography.

  • Quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    SF36 questionnaire.

  • Arrhythmia [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    24 hours Holter monitoring, pacemaker storage data.

  • Ventilatory anaerobic threshold (cardiopulmonary exercise testing) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • VE/VCO2 slope (cardiopulmonary exercise testing). [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Long AV delay. Device: Prolonging atrioventricular (AV) delay.
Prolonging atrioventricular (AV) delay to maximum 350 ms.
Active Comparator: Short AV delay. Device: Standard atrioventricular (AV) delay.
Standard atrioventricular (AV) delay - approximately 180/140 ms depending on heart rate.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • prolonged PQ interval > 200 ms,
  • percentage of right ventricular pacing with standard AV delay > 90.

Exclusion Criteria:

  • second or third degree atrioventricular block,
  • permanent atrial fibrillation.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01611389

Military Institute of Medicine
Warsaw, Poland, 04-141
Sponsors and Collaborators
Military Institute of Medicine, Poland
  More Information Identifier: NCT01611389     History of Changes
Other Study ID Numbers: 83562  N N402 533539 
Study First Received: May 31, 2012
Last Updated: June 4, 2012
Health Authority: Poland: Ministry of Science and Higher Education

Additional relevant MeSH terms:
Sick Sinus Syndrome
Atrioventricular Block
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Pathologic Processes processed this record on January 14, 2017