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

NCT00111527 | Completed Phase 3

• 1 other identifier: 1893A
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 2

Brief 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

Congestive Heart Failure; Atrial Fibrillation

Keywords

Heart failure; Atrial fibrillation; Cardiac resynchronization; Cardiac pacing; Catheter ablation; Quality of life; Echocardiography

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Normal RV pacing

Other: normal RV pacing

2

EXPERIMENTAL

Echo-guided optimization of pacing

Other: Optimized echo-guided CRT pacing

Interventions

Optimized echo-guided CRT pacing OTHER

Echo-TDI guided VV-delay optimization

2

normal RV pacing OTHER

PM or ICD implant according to patient indication

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 failure, depressed LV function in whom a clinical decision had been made to undertake left ventricular synchronization pacing

You may not qualify if:

• New York Heart Association class IV heart failure, or systolic blood pressure ≥80 mmHg
• Severe concomitant non cardiac disease
• Need for surgical intervention
• Myocardial infarction within 3 months
• Primary hypertrophic cardiomyopathy
• Arrhythmogenic right ventricular dysplasia
• Primary valvular heart disease
• Sustained ventricular tachycardia or ventricular fibrillation
• Previously implanted pacemaker
• Inability to obtain reliable RV and LV pacing and persistent AV block

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead
• Medtronic: collaborator

Study Sites (2)

Michele Brignole

Lavagna, Genova, 16033, Italy

Location

Arcispedale S Maria Nuova

Reggio Emilia, Reggio Emilia, 42100, Italy

Location

Related Publications (4)

• Brignole M, Gammage M, Puggioni E, Alboni P, Raviele A, Sutton R, Vardas P, Bongiorni MG, Bergfeldt L, Menozzi C, Musso G; Optimal Pacing SITE (OPSITE) Study Investigators. Comparative assessment of right, left, and biventricular pacing in patients with permanent atrial fibrillation. Eur Heart J. 2005 Apr;26(7):712-22. doi: 10.1093/eurheartj/ehi069. Epub 2004 Dec 20.

  PMID: 15618036 BACKGROUND

• Wood MA, Brown-Mahoney C, Kay GN, Ellenbogen KA. Clinical outcomes after ablation and pacing therapy for atrial fibrillation : a meta-analysis. Circulation. 2000 Mar 14;101(10):1138-44. doi: 10.1161/01.cir.101.10.1138.

  PMID: 10715260 BACKGROUND

• Auricchio A, Abraham WT. Cardiac resynchronization therapy: current state of the art: cost versus benefit. Circulation. 2004 Jan 27;109(3):300-7. doi: 10.1161/01.CIR.0000115583.20268.E1. No abstract available.

  PMID: 14744954 BACKGROUND

• Brignole M, Botto G, Mont L, Iacopino S, De Marchi G, Oddone D, Luzi M, Tolosana JM, Navazio A, Menozzi C. Cardiac resynchronization therapy in patients undergoing atrioventricular junction ablation for permanent atrial fibrillation: a randomized trial. Eur Heart J. 2011 Oct;32(19):2420-9. doi: 10.1093/eurheartj/ehr162. Epub 2011 May 23.

  PMID: 21606084 DERIVED

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michele Brignole, MD

  Ospedali del Tigullio, Lavagna, Italy

  PRINCIPAL INVESTIGATOR

• Carlo Menozzi, MD

  Ospedale S Maria Nuova, Reggio Emilia, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2005
• First Posted: May 23, 2005
• Study Start: May 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: March 1, 2010
• Last Updated: June 12, 2025

Record last verified: 2010-03

Locations

IT (2)