ACC - Atrial Contribution to CRT

Dilated Cardiomyopathy Clinical Trial

Official title:

ACC - Atrial Contribution to CRT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180323
• Other study ID #: ACC Version 1.1 11/09/2003
• Status: Completed
• Phase: N/A
• Start date: November 2004
• Est. completion date: December 2008

Study information

• Verified date: January 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 the event of right atrial pacing.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

Intervention

Device:
• Renewal
Renewal is a CRT-D device for cardiac resynchronization therapy

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aortic Velocity Time Integral (VTI)	Velocity time integral of the aortic flow correlates with cardiac output and is an accepted parameter for optimization of Cardiac Resynchronization Therapy (CRT).	At implant (baseline), 3 months and 6 months Follow-up
Primary	Optimal AV-Delay (AVD)	Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.	Implant (baseline), 3 months and 6 months Follow-up
Secondary	6 Minute Walk Test	6 Minute Walk Test was performed at implant (baseline), 3 months and 6 months follow-up Distance walked within 6 minutes is assessed in meter. This is a test that reflects daily life activities of elderly patients.	implant (baseline), 3 months and 6 months Follow-up
Secondary	Left Ventricular Ejection Fraction (LVEF)	Left ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up	implant (baseline), 3 Months, 6 Months