ACC - Atrial Contribution to CRT

Boston Scientific

Status: Completed

Conditions: Dilated Cardiomyopathy

Treatments: Device: Renewal

Study type: Interventional

Funder types: Industry

Identifiers

NCT00180323

ACC Version 1.1 11/09/2003

Details and patient eligibility

About

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 the event of right atrial pacing.

Full 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 VTI measured by continuous wave Doppler in a modified 4-chamber view. During optimisation aortic VTI will be measured at different heart rates reached by increasing atrial pacing 10, 20 and 30 beats above intrinsic heart rate (IHR).

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Renewal CRT (CRT ICD)

Experimental group

Description:

Single arm study only. 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 VTI (Velocity Time Integral) measured by continuous wave Doppler in a modified 4-chamber view. During optimisation aortic VTI will be measured at different heart rates reached by increasing atrial pacing 10, 20 and 30 beats above intrinsic heart rate (IHR).

Treatment:

Device: Renewal