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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00559143
First Posted: November 16, 2007
Last Update Posted: June 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medtronic Hellas Medical Devices ΑEE
  Purpose
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.

Condition Intervention Phase
Atrioventricular Block Other: Biventricular Pacing (DDD(R)- BiV) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Better Pacing - Biventricular Pacing as Alternative Method in Patients With Disturbances of AV Conduction and Preserved LV Function

Further study details as provided by Medtronic Hellas Medical Devices ΑEE:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment: 38
Study Start Date: November 2007
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
DDD(R)-RV pacing
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
Experimental: 2
DDD(R)- BIV pacing
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559143


Locations
Greece
University Hospital of Crete
Heraklion, Crete, Greece, PO1352
Sponsors and Collaborators
Medtronic Hellas Medical Devices ΑEE
Investigators
Principal Investigator: Emmanuel Simantirakis, MD University Hospital of Crete
Study Chair: Panagiotis Vardas, MD, Cardiology Professor University Hospital of Crete
  More Information

Responsible Party: George Athanasiou/ Senior Field Clinical Research Specialist, Medtronic Hellas Medical Devices ΑEE
ClinicalTrials.gov Identifier: NCT00559143     History of Changes
Other Study ID Numbers: 1111 Version 1.0- 01/May/2007
First Submitted: November 15, 2007
First Posted: November 16, 2007
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by Medtronic Hellas Medical Devices ΑEE:
AV conduction disturbances
LV function
Biventricular Pacing
Conductance Catheters

Additional relevant MeSH terms:
Atrioventricular Block
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes