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This study has been withdrawn prior to enrollment.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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

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 ] [ 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 ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 15, 2007
Last Updated: June 7, 2011
Health Authority: Greece: Ethics Committee
Greece: National Organization of Medicines

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

ClinicalTrials.gov processed this record on July 23, 2014