Trial record 3 of 48 for:    "sick sinus syndrome" OR "sinus node disease" OR "sinus node dysfunction"

Minimizing Ventricular Pacing

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Military Institute of Medicine, Poland.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Military Institute of Medicine, Poland
ClinicalTrials.gov Identifier:
NCT01611389
First received: May 31, 2012
Last updated: June 4, 2012
Last verified: May 2012
  Purpose

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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.
  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: 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
  More Information

No publications provided

ClinicalTrials.gov 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:
Atrioventricular Block
Sick Sinus Syndrome
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus

ClinicalTrials.gov processed this record on August 28, 2014