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Minimizing Ventricular Pacing

Primary Purpose

Sinus Node Disease., First Degree Atrioventricular Block.

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Prolonging atrioventricular (AV) delay.
Standard atrioventricular (AV) delay.
Sponsored by
Military Institute od Medicine National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinus Node Disease.

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Military Institute of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Long AV delay.

Short AV delay.

Arm Description

Outcomes

Primary Outcome Measures

Oxygen uptake (cardiopulmonary exercise testing).

Secondary Outcome Measures

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

Full Information

First Posted
May 31, 2012
Last Updated
June 4, 2012
Sponsor
Military Institute od Medicine National Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01611389
Brief Title
Minimizing Ventricular Pacing
Official Title
Minimizing Right Ventricular Pacing in Dual-chamber Pacemaker Patients With Sinus Node Disease and First Degree Atrioventricular Block.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Military Institute od Medicine National Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinus Node Disease., First Degree Atrioventricular Block.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long AV delay.
Arm Type
Experimental
Arm Title
Short AV delay.
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Prolonging atrioventricular (AV) delay.
Intervention Description
Prolonging atrioventricular (AV) delay to maximum 350 ms.
Intervention Type
Device
Intervention Name(s)
Standard atrioventricular (AV) delay.
Intervention Description
Standard atrioventricular (AV) delay - approximately 180/140 ms depending on heart rate.
Primary Outcome Measure Information:
Title
Oxygen uptake (cardiopulmonary exercise testing).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Left ventricular ejection fraction.
Description
Assessed in echocardiography.
Time Frame
3 months
Title
Quality of life
Description
SF36 questionnaire.
Time Frame
3 months
Title
Arrhythmia
Description
24 hours Holter monitoring, pacemaker storage data.
Time Frame
3 months
Title
Ventilatory anaerobic threshold (cardiopulmonary exercise testing)
Time Frame
3 months
Title
VE/VCO2 slope (cardiopulmonary exercise testing).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Krystian Krzyżanowski, MD
Phone
512 356 207
Ext
48
Email
krystian.krzyzanowski@gmail.com
Facility Information:
Facility Name
Military Institute of Medicine
City
Warsaw
ZIP/Postal Code
04-141
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krystian Krzyżanowski, MD

12. IPD Sharing Statement

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