Left Ventricular Pacing to Avoid Cardiac Enlargement Study | NCT01302717

Studies
Left Ventricular Pacing to Avoid Cardiac Enlargement Study

NCT01302717

Sponsor

Seoul National University Hospital

Status

Withdrawn

Last Update Posted

Apr 18, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Complete AV Block
Sick Sinus Syndrome

Interventions

LV pacing
RV pacing

Countries

South Korea

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

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty in enrollment

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Feb 19, 2011

First Submission Date that Met QC Criteria

Feb 23, 2011

First Posted Date

Feb 24, 2011Estimated

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

Apr 14, 2023

Last Update Posted Date

Apr 18, 2023Actual

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

In this study, the investigators will examine whether left ventricular pacing is superior to right ventricular apical pacing in preventing deterioration of left ventricular systolic function and cardiac remodeling in patients with bradycardia with high risk for development of pacing-induced heart failure.

Detailed Description

In this prospective, we will randomly assign 98 patients who need permanent pacemaker due to complete atrioventricular block or sick sinus syndrome to receive left ventricular pacing (49 patients) or right ventricular apical pacing (49 patients). Patients will be paced with temporary pacemaker lead, and only those with paced QRS duration ≥185 ms will be enrolled.

The primary endpoint is left ventricular ejection fraction measured by modified Simpson method at 12 months. The secondary end points include left ventricular systolic end-systolic and diastolic volume, LV strain, NYHA functional class, exercise performance (using treadmill test), quality of life (using SF-36v2), NT-proBNP at 12 months.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Right ventricular pacing	Active Comparator		Device: RV pacing
Left ventricular pacing	Experimental		Device: LV pacing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LV pacing	Device	The left ventricular lead are positioned preferentially at the posterolateral or lateral venous branches of the coronary sinus.	Left ventricular pacing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Left ventricular ejection fraction (%) at 12 months	Measured by modified Simpson's method	12 months

Secondary Outcomes

Measure	Description	Time Frame
Left ventricular end-systolic volume (ml) at 12 months	Measured by modified Simpson method	12 months
Left ventricular end-diastolic volume (ml) at 12 months	Measured by modified Simpson method

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sinus-node dysfunction or bradycardia due to advanced atrioventricular block
Paced QRS duration ≥185 ms

Exclusion Criteria:

Left ventricular ejection fraction < 50 %
Acute coronary syndrome
If they had undergone percutaneous coronary intervention or coronary-artery bypass surgery within the previous 3 months
if they had a life expectancy of less than 1 year
if they had received a heart transplant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seil Oh, MD, PhD	Seoul National University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam		464-707	South Korea
Seoul National University Hospital

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

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Browse Branches

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