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Optimized echo-guided CRT pacing, normal RV pacing

Phase 3

Congestive Heart Failure | Unknown | Cardiovascular |Medtronic plc.|Last Updated: Jun 12, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment458

FDA Designations

No designations recorded

Clinical trial landscape

Optimized echo-guided CRT pacing, normal RV pacing · 1 trial · 2 indications

Phase 3 1
NCT00111527APAF: Assessment of Cardiac Resynchronization Therapy in Patients With Permanent Atrial FibrillationCongestive Heart Failure
COMPLETED458 Analytics
PHASE3COMPLETED
APAF: Assessment of Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation
Congestive Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Short-term clinical study (6 months): Quality of life (measured as Minnesota Living with Heart Failure Questionnaire, Specific Symptom Scale and New York Heart Association classification) and exercise capacity at 6 months in the 2 study groups
6 months
Long-term clinical study (24 months): Composite end-point of: death due to cardiovascular cause, hospitalisation for worsening heart failure, worsening heart failure or failure to achieve a persistent subjective symptom improvement (clinical failure)
24 months

Secondary Endpoints

The evaluation of the predictive value of echo desynchronisation indexes (inter and intra-LV delays) for identification of clinical failure (see above)
24 months
Cost-benefit comparison of the 2 pacing strategies
24 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORNormal RV pacing
2EXPERIMENTALEcho-guided optimization of pacing

Interventions

NameTypeDescription
Optimized echo-guided CRT pacingOTHEREcho-TDI guided VV-delay optimization
normal RV pacingOTHERPM or ICD implant according to patient indication
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Patients with permanent AF in whom a clinical decision had been made to undertake complete AV junction ablation and ventricular pacing because of drug-refractory, severely symptomatic, uncontrolled high ventricular rate * Patients with permanent AF, drug-refractory heart failu...

Countries:Italy
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Frequently asked questions about Optimized echo-guided CRT pacing, normal RV pacing

What is Optimized echo-guided CRT pacing, normal RV pacing used for?

Optimized echo-guided CRT pacing, normal RV pacing is a cardiac resynchronization therapy (CRT) pacing strategy being studied for use in congestive heart failure, specifically in patients with permanent atrial fibrillation. It involves optimizing CRT delivery through echocardiographic guidance compared to normal right ventricular pacing.

Who makes Optimized echo-guided CRT pacing, normal RV pacing?

Optimized echo-guided CRT pacing, normal RV pacing is developed by Medtronic plc, a medical device company traded on the New York Stock Exchange under the ticker symbol MDT. The company is conducting clinical research to evaluate this pacing approach in heart failure patients.

What phase is Optimized echo-guided CRT pacing, normal RV pacing in?

Optimized echo-guided CRT pacing, normal RV pacing is in Phase 3 clinical development. It is an investigational pacing strategy, not yet approved, and is being evaluated in a completed Phase 3 trial for congestive heart failure with permanent atrial fibrillation.

What clinical trials is Optimized echo-guided CRT pacing, normal RV pacing in?

Optimized echo-guided CRT pacing, normal RV pacing was studied in the APAF trial, registered as NCT00111527. This Phase 3, randomized, double-blind, active-controlled trial enrolled 458 patients with congestive heart failure and permanent atrial fibrillation in Italy. The trial has been completed.

Is Optimized echo-guided CRT pacing, normal RV pacing the same as cardiac resynchronization therapy?

Optimized echo-guided CRT pacing, normal RV pacing is a specific cardiac resynchronization therapy (CRT) approach. It compares echocardiographically optimized CRT pacing against normal right ventricular pacing to determine the best pacing strategy for heart failure patients with atrial fibrillation.