Status:
COMPLETED
Progressive Ventricular Dysfunction Prevention in Pacemaker Patients
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Cardiac Pacing Indication classI/IIa According AHA/ACC
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this pilot study is to evaluate the progression of ventricular dysfunction in patients with ventricular dysfunction within the permanent pacing population.
Detailed Description
The interventricular synchrony is one of the components of a proper cardiac function. When there is no synchrony -as in left bundle block (LBBB)- the clinic consequences should have little importance ...
Eligibility Criteria
Inclusion
- Meet Class I and/or Class IIa implantation criteria for permanent cardiac pacing according to the guidelines given by the American College of Cardiology (ACC)/American Heart Association(AHA).
Exclusion
- Expected ventricle stimulation \<80% of the time
- Impossibility of dual chamber stimulation in the absence of AF
- Severe heart failure (NYHA Functional class III-IV) previous to indication for pacing device implant
- Patient needs revascularization within 3 months
- Myocardial infarction in the last 3 months
- Cardiac surgery performed in the last 3 months
- Hypertrophic cardiomyopathy
- Constrictive pericarditis
- Bad echo window
- Previous system implanted (ICD or pacemaker)
- Aortic stenosis
- Patient has a mechanical right heart valve
- Patient \<18 years
- Pregnancy
- Patient has medical conditions that would preclude the testing required by the protocol, or limit study participation
- Life expectancy \<1year
- Patient is unwilling or unable to cooperate or give written informed consent.
- Patient is or will be inaccessible for follow-up at the study center.
- Patients who are participating or planning to participate in other clinical trials during the clinical study
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00170326
Start Date
January 1 2002
End Date
March 1 2009
Last Update
July 3 2025
Active Locations (5)
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1
Hospital General de Alicante
Alicante, Spain
2
H. Infanta Cristina
Badajoz, Spain
3
H. Clínic i Provincial
Barcelona, Spain
4
H. Puerta de Hierro
Madrid, Spain, 28035