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This study has been withdrawn prior to enrollment.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:
Medtronic Hellas Medical Devices ΑEE
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
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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
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 May 16, 2013