B-Left HF: Biventricular Versus Left Univentricular Pacing With Implantable Cardiac Defibrillator (ICD) Back-Up in Heart Failure Patients

Heart Failure Clinical Trial

Official title:

Biventricular Versus Left Univentricular Pacing With ICD Back-up in Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00187213
• Other study ID #: CR03019HF
• Status: Completed
• Phase: N/A
• Start date: December 2004
• Est. completion date: January 2008

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate that biventricular pacing (BiV) and left univentricular (left ventricular [LV] only) pacing are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a cardiac resynchronization therapy defibrillator (CRT-D) device.

The hypothesis to be tested by this clinical investigation is that patients indicated for an ICD with cardiac resynchronization therapy respond as well to LV only pacing as to BiV pacing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have an approved indication for implantation of an ICD for treatment of a life-threatening ventricular tachyarrhythmia(s)

• Have advanced heart failure with a New York Heart Association (NYHA) classification of III or IV, despite receiving a minimum of 30 days of stable optimal pharmacological therapy

• Have a ventricular conduction delay manifested as a QRS width >= 130 ms

• Have a left ventricular end diastolic diameter (LVEDD) >= 55 mm

• Have a left ventricular ejection fraction (LVEF) <= 35%

Exclusion Criteria:

• Have a CRT device already implanted

• Have a standard indication for bradycardia pacing

• Have a history of chronic atrial fibrillation [AF] (continuous AF lasting > 1 month) within 1 year prior to enrollment or have undergone cardioversion for AF in the past month)

• Have the ability to walk > 450 meters during the 6-minute walk test

• Have uncorrected primary valvular disease

• Have had a recent myocardial infarction, unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty [PTCA] or coronary artery bypass graft [CABG]) within 1 month of enrollment

• Have had cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment

• Have a life expectancy of less than one year

• Are unable to comply with the follow-up schedule and tests

• Are minors (age below 18 years)

• Are pregnant or are planning for pregnancy in the next 6 months

Related Conditions & MeSH terms

• Heart Diseases
• Heart Failure
• Ventricular Dysfunction

Intervention

Device:
• Cardiac Resynchronization Therapy

Locations

Country	Name	City	State
France	Department of Cardiology - CHU Pontchaillou	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to demonstrate that left univentricular pacing is equivalent to biventricular pacing in improving the functional capacity and inducing reverse remodeling.
Secondary	The secondary objective of this clinical investigation is to evaluate the proportion of improved patients in each group, using the Heart Failure Clinical Composite Response.