Biventricular Alternative Pacing

NCT00559143 | Withdrawn Phase 4

• 1 other identifier: 1111 Version 1.0- 01/May/2007
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrioventricular Block

Keywords

AV conduction disturbances; LV function; Biventricular Pacing; Conductance Catheters

Outcome Measures

Primary Outcomes (1)

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

  two years

Secondary Outcomes (2)

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

  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.

  two years

Study Arms (2)

1

ACTIVE COMPARATOR

DDD(R)-RV pacing

Other: Biventricular Pacing (DDD(R)- BiV)

2

EXPERIMENTAL

DDD(R)- BIV pacing

Other: Biventricular Pacing (DDD(R)- BiV)

Interventions

Biventricular Pacing (DDD(R)- BiV) OTHER

Subjects indicated for DDD(R) pacing due to AV conduction disturbances and preserved LV function will receive biventricular pacing DDD(R)- BiV

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Hellas Medical Devices ΑEE: lead

Study Sites (1)

University Hospital of Crete

Heraklion, Crete, PO1352, Greece

Location

MeSH Terms

Conditions

Atrioventricular Block

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Emmanuel Simantirakis, MD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

• Panagiotis Vardas, MD, Cardiology Professor

  University Hospital of Crete

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: November 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: July 1, 2011
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

GR (1)