Minimizing Ventricular Pacing

First Degree Atrioventricular Block. Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01611389
• Other study ID #: 83562
• Secondary ID: N N402 533539
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2012
• Last updated: June 4, 2012
• Start date: September 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2012
• Source: Military Institute of Medicine, Poland
• Contact: Krystian Krzyzanowski, MD
• Phone: 512 356 207
• Email: krystian.krzyzanowski[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrioventricular Block
• First Degree Atrioventricular Block.
• Sick Sinus Syndrome
• Sinus Node Disease.

Intervention

Device:
• Prolonging atrioventricular (AV) delay.
Prolonging atrioventricular (AV) delay to maximum 350 ms.
• Standard atrioventricular (AV) delay.
Standard atrioventricular (AV) delay - approximately 180/140 ms depending on heart rate.

Locations

Country	Name	City	State
Poland	Military Institute of Medicine	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Military Institute of Medicine, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen uptake (cardiopulmonary exercise testing).		3 months	No
Secondary	Left ventricular ejection fraction.	Assessed in echocardiography.	3 months	No
Secondary	Quality of life	SF36 questionnaire.	3 months	No
Secondary	Arrhythmia	24 hours Holter monitoring, pacemaker storage data.	3 months	Yes
Secondary	Ventilatory anaerobic threshold (cardiopulmonary exercise testing)		3 months	No
Secondary	VE/VCO2 slope (cardiopulmonary exercise testing).		3 months	No