ACC - Atrial Contribution to CRT

NCT00180323 | Completed Results

• 1 other identifier: ACC Version 1.1 11/09/2003
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Dilated Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• 6 Minute Walk Test

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

• Left Ventricular Ejection Fraction (LVEF)

  implant (baseline), 3 Months, 6 Months

Study Arms (1)

Renewal CRT (CRT ICD)

EXPERIMENTAL

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).

Device: Renewal

Interventions

Renewal DEVICE

Renewal is a CRT-D device for cardiac resynchronization therapy

Renewal CRT (CRT ICD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms of heart failure
• Left ventricular dysfunction
• Ventricular dyssynchrony
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Jesper Hastrup Svendsen
• Organization: Rigshospitalet, Copenhagen Unviversity Hospital, Denmark

jesper.hastrup.svendsen@rh.regionh.dk

Study Officials

• Jasper Hastrup Svendson, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: November 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 11, 2021
• Results First Posted: November 12, 2012

Record last verified: 2021-01

Locations

DK (1)