Minimizing Ventricular Pacing
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment|
|Sinus Node Disease. First Degree Atrioventricular Block.||Device: Prolonging atrioventricular (AV) delay. Device: Standard atrioventricular (AV) delay.|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- Oxygen uptake (cardiopulmonary exercise testing). [ Time Frame: 3 months ]
- Left ventricular ejection fraction. [ Time Frame: 3 months ]Assessed in echocardiography.
- Quality of life [ Time Frame: 3 months ]SF36 questionnaire.
- Arrhythmia [ Time Frame: 3 months ]24 hours Holter monitoring, pacemaker storage data.
- Ventilatory anaerobic threshold (cardiopulmonary exercise testing) [ Time Frame: 3 months ]
- VE/VCO2 slope (cardiopulmonary exercise testing). [ Time Frame: 3 months ]
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
|Contact: Krystian Krzyżanowski, MD||512 356 207 ext firstname.lastname@example.org|
|Military Institute of Medicine||Recruiting|
|Warsaw, Poland, 04-141|
|Principal Investigator: Krystian Krzyżanowski, MD|