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Minimizing Ventricular Pacing

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ClinicalTrials.gov Identifier: NCT01611389
Recruitment Status : Unknown
Verified May 2012 by Military Institute of Medicine, Poland.
Recruitment status was:  Recruiting
First Posted : June 5, 2012
Last Update Posted : June 5, 2012
Sponsor:
Information provided by:
Military Institute of Medicine, Poland

Brief Summary:
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 or disease Intervention/treatment Phase
Sinus Node Disease. First Degree Atrioventricular Block. Device: Prolonging atrioventricular (AV) delay. Device: Standard atrioventricular (AV) delay. Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : September 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Oxygen uptake (cardiopulmonary exercise testing). [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Left ventricular ejection fraction. [ Time Frame: 3 months ]
    Assessed in echocardiography.

  2. Quality of life [ Time Frame: 3 months ]
    SF36 questionnaire.

  3. Arrhythmia [ Time Frame: 3 months ]
    24 hours Holter monitoring, pacemaker storage data.

  4. Ventilatory anaerobic threshold (cardiopulmonary exercise testing) [ Time Frame: 3 months ]
  5. VE/VCO2 slope (cardiopulmonary exercise testing). [ Time Frame: 3 months ]


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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611389


Contacts
Contact: Krystian Krzyżanowski, MD 512 356 207 ext 48 krystian.krzyzanowski@gmail.com

Locations
Poland
Military Institute of Medicine Recruiting
Warsaw, Poland, 04-141
Principal Investigator: Krystian Krzyżanowski, MD         
Sponsors and Collaborators
Military Institute of Medicine, Poland

ClinicalTrials.gov Identifier: NCT01611389     History of Changes
Other Study ID Numbers: 83562
N N402 533539 ( Other Grant/Funding Number: National Science Centre )
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Atrioventricular Block
Sick Sinus Syndrome
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus