Minimizing Ventricular Pacing | NCT01611389

Studies
Minimizing Ventricular Pacing

NCT01611389

Sponsor

Military Institute od Medicine National Research Institute

Status

Unknown status

Last Update Posted

Jun 5, 2012Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Sinus Node Disease.
First Degree Atrioventricular Block.

Interventions

Prolonging atrioventricular (AV) delay.
Standard atrioventricular (AV) delay.

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
N N402 533539	Other Grant/Funding Number	National Science Centre

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

May 31, 2012

First Submission Date that Met QC Criteria

Jun 4, 2012

First Posted Date

Jun 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2012

Last Update Posted Date

Jun 5, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Military Institute od Medicine National Research InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Long AV delay.	Experimental		Device: Prolonging atrioventricular (AV) delay.
Short AV delay.	Active Comparator		Device: Standard atrioventricular (AV) delay.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prolonging atrioventricular (AV) delay.	Device	Prolonging atrioventricular (AV) delay to maximum 350 ms.	Long AV delay.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Left ventricular ejection fraction.	Assessed in echocardiography.	3 months
Quality of life	SF36 questionnaire.	3 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Krystian Krzyżanowski, MD	Contact	512 356 207	48	krystian.krzyzanowski@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Military Institute of Medicine	Recruiting	Warsaw		04-141	Poland

Condition Browse Module

MeSH Terms

ID	Term
D012804	Sick Sinus Syndrome

Ancestor Terms

ID	Term
D001146	Arrhythmia, Sinus
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided