NCT01439529

ECG Optimization of CRT: Evaluation of Mid-term Response

Optimization of Response to Cardiac Resynchronization Therapy by Electrocardiogram: an Assessment of Medium-term Response

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

New simpler methods to optimize cardiac resynchronization therapy (CRT) are being evaluated, such as the use of the electrocardiogram. In this prospective, double-blind, study, the investigators will evaluate: Primary endpoint: To compare the clinical response to CRT in patients with the programming optimized by QRS versus the nominal suggested by the device. Secondary endpoints: 1. To compare cardiac remodeling in patients with the programming optimized by QRS versus the nominal suggested by the device. 2. To evaluate the degree of asynchrony in both groups (nominal versus optimization by QRS) with respect to the intrinsic rhythm. 3. To evaluate the echocardiographic improvement in left ventricular (LV) filling in both groups. 4. To evaluate the differences in the optimal atrioventricular (AV) delay with atrial sensing or atrial pacing. For that, 180 patients with an indication for CRT will be randomized to nominal programming of the device or optimization by the electrocardiogram for a narrower QRS. A clinical and echocardiographic evaluation will be done at baseline, 6 and 12 months.

Conditions

• Heart Failure

Interventions

Type	Name	Description
OTHER	Device programming: nominal	CRT device is programmed to nominal values
OTHER	Programming optimization by QRS	CRT device is programmed by QRS optimization

Timeline

• Start date: 2009-04-01
• Primary completion: 2016-09-01
• Completion: 2017-09-01
• First posted: 2011-09-23
• Last updated: 2018-08-02

Locations

1 site across 1 country: Spain