Biventricular Alternative Pacing | NCT00559143

Studies
Biventricular Alternative Pacing

NCT00559143

Sponsor

Medtronic Hellas Medical Devices ΑEE

Status

Withdrawn

Last Update Posted

Jun 8, 2011Estimated

Enrollment

38Estimated

Phase

Phase 4

Conditions

Atrioventricular Block

Interventions

Biventricular Pacing (DDD(R)- BiV)

Countries

Greece

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

Jun 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patients enrolled for long period of time. No scientific interest any more

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Nov 2009Estimated

Completion Date

Jul 2011Estimated

First Submitted Date

Nov 15, 2007

First Submission Date that Met QC Criteria

Nov 15, 2007

First Posted Date

Nov 16, 2007Estimated

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 7, 2011

Last Update Posted Date

Jun 8, 2011Estimated

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

Aim of present study is to examine the short and long-term results of pacing from right ventricular apex and to compare them with those of biventricular pacing.

Detailed Description

In this study all subjects to be studied will have atrioventricular conduction disturbances that require permanent artificial pacing. In all subjects a biventricular pacemaker will be implanted. Moreover the subjects will be randomized in a biventricular or conventional pacing mode and will be observed for a long term period.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	DDD(R)-RV pacing	Other: Biventricular Pacing (DDD(R)- BiV)
2	Experimental	DDD(R)- BIV pacing	Other: Biventricular Pacing (DDD(R)- BiV)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biventricular Pacing (DDD(R)- BiV)	Other	Subjects indicated for DDD(R) pacing due to AV conduction disturbances and preserved LV function will receive biventricular pacing DDD(R)- BiV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in End Diastolic Diameter of Left Ventricle with the two different ways of pacing (DDD(R)-RV & DDD(R)-BiV)		two years

Secondary Outcomes

Measure	Description	Time Frame
Tolerance in the cardiopulmonary stress test, quality of life, LV function and changes of BNP, TNF, interleukin-6, interleukin-12 and oxidant stress.		two years
Assessment of the operation of Left Ventricle at the different pacing types using conductance catheters in a subgroup of patients that will perform a programmed coronary angiography due to investigation of possible coronary artery disease.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects between the age of 18 to 75 years with classic indication for permanent artificial pacing in which it is expected very high percentage of ventricular pacing, (pacing systoles constitute the 80% and more of the total).
Physiologic or mildly affected systolic function of left ventricle, LVEF> 40%.
Subject is willing and able to comply with the Clinical Investigational Plan and to remain available for follow-up visits, through study closure.
Subject (or if allowed by local law/regulations: subject's legally authorised representative) is willing and able to sign and date the study Informed Consent.

Exclusion Criteria:

Subjects with classic indication for Biventricular Pacing - (European Guidelines 2007).
Permanent atrial fibrillation.
Cardiovascular surgery within the last three months prior to enrollment.
Myocardial infarction within the last three months prior to enrollment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emmanuel Simantirakis, MD	University Hospital of Crete	Principal Investigator
Panagiotis Vardas, MD, Cardiology Professor	University Hospital of Crete	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Crete		Heraklion	Crete	PO1352	Greece

Condition Browse Module

MeSH Terms

ID	Term
D054537	Atrioventricular Block

Ancestor Terms

ID	Term
D006327	Heart Block
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D058406	Cardiac Resynchronization Therapy

Ancestor Terms

ID	Term
D002304	Cardiac Pacing, Artificial
D004599	Electric Stimulation Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided