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APAF: Assessment of Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation

NCT00111527 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 458

Last updated 2025-06-12

No results posted yet for this study

Summary

A suboptimal level of resynchronization (cardiac resynchronization therapy \[CRT\]) achieved in many patients with actual standards and techniques based on tissue-Doppler echocardiography could be more effective to obtain better CRT results. Eligible patients who successfully received atrioventricular (AV) junction ablation and biventricular (BiV) pacing are randomised to a comparison between a strategy of right ventricular (RV) apical pacing with delayed CRT based on clinical indications with a strategy of early optimal CRT based on an echocardiographic stratification.

End-points:

* Acute echo comparison (acute echo study)
* Quality of life and exercise tolerance (Short-term clinical study)
* Composite end-point of CRT clinical failure (Long-term clinical study)

Conditions

Interventions

OTHER

Optimized echo-guided CRT pacing

Echo-TDI guided VV-delay optimization

OTHER

normal RV pacing

PM or ICD implant according to patient indication

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Azienda USL Reggio Emilia - IRCCS

    lead OTHER_GOV

Principal Investigators

  • Michele Brignole, MD · Ospedali del Tigullio, Lavagna, Italy

  • Carlo Menozzi, MD · Ospedale S Maria Nuova, Reggio Emilia, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2009-08-31
Completion
2010-03-31

Countries

  • Italy

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00111527 on ClinicalTrials.gov