Biventricular Alternative Pacing (BETTER)

This study has been withdrawn prior to enrollment.
(No patients enrolled for long period of time. No scientific interest any more)
Sponsor:
Information provided by:
Medtronic Hellas Medical Devices ΑEE
ClinicalTrials.gov Identifier:
NCT00559143
First received: November 15, 2007
Last updated: June 7, 2011
Last verified: June 2011

November 15, 2007
June 7, 2011
November 2007
November 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00559143 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Biventricular Alternative Pacing
Better Pacing - Biventricular Pacing as Alternative Method in Patients With Disturbances of AV Conduction and Preserved LV Function

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Atrioventricular Block
Other: Biventricular Pacing (DDD(R)- BiV)
Subjects indicated for DDD(R) pacing due to AV conduction disturbances and preserved LV function will receive biventricular pacing DDD(R)- BiV
  • Active Comparator: 1
    DDD(R)-RV pacing
    Intervention: Other: Biventricular Pacing (DDD(R)- BiV)
  • Experimental: 2
    DDD(R)- BIV pacing
    Intervention: Other: Biventricular Pacing (DDD(R)- BiV)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
38
July 2011
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00559143
1111 Version 1.0- 01/May/2007
No
George Athanasiou/ Senior Field Clinical Research Specialist, Medtronic Hellas Medical Devices ΑEE
Medtronic Hellas Medical Devices ΑEE
Not Provided
Principal Investigator: Emmanuel Simantirakis, MD University Hospital of Crete
Study Chair: Panagiotis Vardas, MD, Cardiology Professor University Hospital of Crete
Medtronic Hellas Medical Devices ΑEE
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP