N/A N=43 Treatment

ACC - Atrial Contribution to CRT

Dilated Cardiomyopathy

Bottom Line

View on ClinicalTrials.gov: NCT00180323 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2012

Primary outcome: Primary: Aortic Velocity Time Integral (VTI) — 22.4; 21.7; 19.4; 18.1 cm

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Renewal (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boston Scientific Corporation
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Aortic Velocity Time Integral (VTI)	22.4; 21.7; 19.4; 18.1; 23.6; 21.9	—
PRIMARY Optimal AV-Delay (AVD)	115; 119; 123; 127; 117; 117	—
SECONDARY 6 Minute Walk Test	388; 470; 497	—
SECONDARY Left Ventricular Ejection Fraction (LVEF)	21; 24; 24	—

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.

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)
Not meeting the inclusion criteria

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00180323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.