Status:
COMPLETED
ACC - Atrial Contribution to CRT
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Dilated Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This prospective study will evaluate in patients, fulfilling implant criteria for Cardiac Resynchronisation Therapy (CRT) implant, the optimal atrial contribution to the resynchronised ventricles in t...
Detailed Description
All patients will undergo advanced echocardiographic examination pre-operative, pre-discharge after implantation and at 3 and 6-months follow-up. AV-delay optimization will be performed using aortic V...
Eligibility Criteria
Inclusion
- Symptoms of heart failure
- Left ventricular dysfunction
- Ventricular dyssynchrony
- 18 years or of legal age in order to give informed consent according to national laws
- Able to understand the nature of the procedure
- Available for follow-up on a regular basis at an approved investigational center
Exclusion
- Atrial Fibrillation
- Life expectancy of less than six months due to other medical conditions
- For women: pregnancy or absence of medically accepted birth control
- Inability or refusal to sign the Patient Informed Consent
- Inability or refusal to comply with the follow up schedule or protocol requirements
- Inability to undergo device implant, including general anaesthesia if required
- Mechanical tricuspid prosthesis
- Currently enrolled in another investigational study, including drug investigations
- Hypertrophic Obstructive Cardiomyopathy (HOCM)
- Not meeting the inclusion criteria
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00180323
Start Date
November 1 2004
End Date
December 1 2008
Last Update
February 11 2021
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark