Minimizing Ventricular Pacing

June 4, 2012 updated by: Military Institute of Medicine, Poland

Minimizing Right Ventricular Pacing in Dual-chamber Pacemaker Patients With Sinus Node Disease and First Degree Atrioventricular Block.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Warsaw, Poland, 04-141
        • Recruiting
        • Military Institute of Medicine
        • Principal Investigator:
          • Krystian Krzyżanowski, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oxygen uptake (cardiopulmonary exercise testing).
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction.
Time Frame: 3 months
Assessed in echocardiography.
3 months
Quality of life
Time Frame: 3 months
SF36 questionnaire.
3 months
Arrhythmia
Time Frame: 3 months
24 hours Holter monitoring, pacemaker storage data.
3 months
Ventilatory anaerobic threshold (cardiopulmonary exercise testing)
Time Frame: 3 months
3 months
VE/VCO2 slope (cardiopulmonary exercise testing).
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Military Institute of Medicine, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

May 31, 2012

First Submitted That Met QC Criteria

June 4, 2012

First Posted (Estimate)

June 5, 2012

Study Record Updates

Last Update Posted (Estimate)

June 5, 2012

Last Update Submitted That Met QC Criteria

June 4, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83562
  • N N402 533539 (Other Grant/Funding Number: National Science Centre)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sinus Node Disease.

Clinical Trials on Prolonging atrioventricular (AV) delay.

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