ACC - Atrial Contribution to CRT

NCT ID: NCT00180323

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2008-12-31

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 the event of right atrial pacing.

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 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).

Conditions

Dilated Cardiomyopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renewal CRT (CRT ICD)

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).

Group Type: EXPERIMENTAL

Renewal

Intervention Type: DEVICE

Renewal is a CRT-D device for cardiac resynchronization therapy

Interventions

Renewal

Renewal is a CRT-D device for cardiac resynchronization therapy

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jasper Hastrup Svendson, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

ACC Version 1.1 11/09/2003

Identifier Type: -

Identifier Source: org_study_id