ACC - Atrial Contribution to CRT

Boston Scientific Corporation43 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dilated Cardiomyopathy

Interventions

RenewalDEVICE

Renewal is a CRT-D device for cardiac resynchronization therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

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).

Time frame: At implant (baseline), 3 months and 6 months Follow-up

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.

Time frame: Implant (baseline), 3 months and 6 months Follow-up

Secondary Outcomes

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.

Time frame: implant (baseline), 3 months and 6 months Follow-up

Left Ventricular Ejection Fraction (LVEF)

Left ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up

Time frame: implant (baseline), 3 Months, 6 Months

Data from ClinicalTrials.gov

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