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Biventricular Alternative Pacing (BETTER)

Primary Purpose

Atrioventricular Block

Status
Withdrawn
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Biventricular Pacing (DDD(R)- BiV)
Sponsored by
Medtronic Hellas Medical Devices ΑEE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrioventricular Block focused on measuring AV conduction disturbances, LV function, Biventricular Pacing, Conductance Catheters

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of Crete

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

DDD(R)-RV pacing

DDD(R)- BIV pacing

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tolerance in the cardiopulmonary stress test, quality of life, LV function and changes of BNP, TNF, interleukin-6, interleukin-12 and oxidant stress.
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.

Full Information

First Posted
November 15, 2007
Last Updated
June 7, 2011
Sponsor
Medtronic Hellas Medical Devices ΑEE
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1. Study Identification

Unique Protocol Identification Number
NCT00559143
Brief Title
Biventricular Alternative Pacing
Acronym
BETTER
Official Title
Better Pacing - Biventricular Pacing as Alternative Method in Patients With Disturbances of AV Conduction and Preserved LV Function
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Withdrawn
Why Stopped
No patients enrolled for long period of time. No scientific interest any more
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Medtronic Hellas Medical Devices ΑEE

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrioventricular Block
Keywords
AV conduction disturbances, LV function, Biventricular Pacing, Conductance Catheters

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
DDD(R)-RV pacing
Arm Title
2
Arm Type
Experimental
Arm Description
DDD(R)- BIV pacing
Intervention Type
Other
Intervention Name(s)
Biventricular Pacing (DDD(R)- BiV)
Intervention Description
Subjects indicated for DDD(R) pacing due to AV conduction disturbances and preserved LV function will receive biventricular pacing DDD(R)- BiV
Primary Outcome Measure Information:
Title
Change in End Diastolic Diameter of Left Ventricle with the two different ways of pacing (DDD(R)-RV & DDD(R)-BiV)
Time Frame
two years
Secondary Outcome Measure Information:
Title
Tolerance in the cardiopulmonary stress test, quality of life, LV function and changes of BNP, TNF, interleukin-6, interleukin-12 and oxidant stress.
Time Frame
two years
Title
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.
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Simantirakis, MD
Organizational Affiliation
University Hospital of Crete
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Panagiotis Vardas, MD, Cardiology Professor
Organizational Affiliation
University Hospital of Crete
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Crete
City
Heraklion
State/Province
Crete
ZIP/Postal Code
PO1352
Country
Greece

12. IPD Sharing Statement

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Biventricular Alternative Pacing

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