Echocardiography Guided Cardiac Resynchronization Therapy Clinical Investigatio

Phase 3

Completed

• Conditions: Heart Failure; weakened heart muscle; 10082206

• Registration Number: NL-OMON32443
• Lead Sponsor: BIOTRONIK Inc. - clinical study department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

indication for ICD
systolic heart failure: LVEF < 35% and LVEDD > 55 mm
NYHA III-IV under optimal medical therapy
QRS < 130 ms
ventricular dyssynchrony measured by Echo + confirmed by Echo Core Lab
18 years of age or older

Exclusion Criteria

Contraindication(s) to an ICD.
Already implanted with a pacemaker or an ICD
Bradycardia pacing indication
Pregnant, lactating or planning to become pregnant females.
CABG, PTCA, or MI within the past 3 months prior to enrollment or CABG or PTCA intervention planned in the next 3 months.
Irreversible brain damage from preexisting cerebral disease.
Reversible non-ischemic cardiomyopathy such as acute viral myocarditis.
Permanent 2º or 3º heart block.
Chagas disease.
Persistent, permanent, or paroxysmal atrial fibrillation within 1 month prior to enrollment.
Expected to receive heart transplantation within 6 months.
Have a life expectancy of less than 6 months
Creatinine > 2.5 mg/dL or liver failure

Study & Design

• Study Type: Interventional
• Study Design: Not specified