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Congestive Heart FailurePhase 3NCT00111527

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

A Phase 3 study testing Optimized echo-guided CRT pacing and normal RV pacing in people with Congestive Heart Failure and Atrial Fibrillation, run by Azienda USL Reggio Emilia - IRCCS at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Congestive Heart Failure, Atrial Fibrillation
What is being tested?
Optimized echo-guided CRT pacing and normal RV pacing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
458 participants
Where
2 sitesItaly
Study dates
May 2005to Mar 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Michele Brignole

    Lavagna, Genova, 16033

  • Arcispedale S Maria Nuova

    Reggio Emilia, Reggio Emilia, 42100

Other trials in Italy

About this study

Official title: An Assessment of the Echo-guided Optimal Cardiac Resynchronization Therapy in Patients Undergoing 'Ablate And Pace' Therapy for Permanent Atrial Fibrillation

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)
Read the detailed description

Background: Cardiac resynchronization therapy (CRT) in patients in atrial fibrillation (AF) seems to provide modest favorable effect compared with RV pacing. In the Optimal Pacing SITE (OPSITE) trial the results were heterogeneous. The situation was almost certainly one in which some patients are showing marked clinical benefit with LV-based pacing, balanced by other patients in whom RV was the best choice. Therefore with the actual standards, CRT pacing cannot be recommended as a first line treatment for all patients with AF and refractory heart failure and new criteria to identify the patients who might benefit are needed. Furthermore, a pre-requisite for CRT in patients with AF is the presence of stable 3rd degree AV block which usually implies the need for performing catheter ablation of the AV junction.

Study hypothesis: We hypothesized that a suboptimal level of resynchronization is achieved in many patients with actual standards and that some techniques based on tissue-Doppler echocardiography could be more effective to obtain better (hopefully optimal) CRT results.

Objective: The aim of the APAF+ heart failure (HF) trial is to compare, in patients affected by permanent AF and refractory heart failure, a strategy of delayed CRT based on clinical indications with a strategy of early optimal CRT based on an echocardiographic stratification.

Study protocol: Eligible patients who successfully received AV junction ablation and biventricular pacing are randomised to a comparison between a strategy of RV apical pacing with delayed CRT based on clinical indications with a strategy of early optimal CRT based on an echocardiographic stratification. The optimal CRT is defined as the shortest intra-LV delay obtained with tissue-doppler echocardiography among RV, LV and BiV optimised VV interval.

An acute echocardiographic evaluation is performed shortly after randomisation. A short-term clinical evaluation is performed after 6 months. A long-term clinical evaluation is performed up to 24 months.

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)

Study size: The study will randomise 458 patients and will be conducted in 46 centres with an average of 10 patients per centre. Patient enrolment time is anticipated to last 2 years. As the study will continue for a period of 12 months after the enrolment of the last patient, total study duration will be approximately 3 years.

Being tested
Optimized echo-guided CRT pacing, normal RV pacing
Keywords
Heart failure, Atrial fibrillation, Cardiac resynchronization, Cardiac pacing, Catheter ablation, Quality of life, Echocardiography
Medical subject headings
Heart Failure, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optimized echo-guided CRT pacingOther

    Echo-TDI guided VV-delay optimization

  • normal RV pacingOther

    PM or ICD implant according to patient indication

Study groups in NCT00111527
Study groupRoleWhat they receive
1Active comparatorNormal RV pacing
Receives: Other: normal RV pacing
2ExperimentalEcho-guided optimization of pacing
Receives: Other: Optimized echo-guided CRT pacing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

  2. 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)

    Measured: 24 months

Secondary outcomes (2)

  1. The evaluation of the predictive value of echo desynchronisation indexes (inter and intra-LV delays) for identification of clinical failure (see above)

    Measured: 24 months

  2. Cost-benefit comparison of the 2 pacing strategies

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionAug 2009
  4. Study completionMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
458 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00111527
Sponsor's protocol ID
1893A
Status last verified
Mar 2010
First submitted
20 May 2005
Last updated
12 Jun 2025
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15618036

  • 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.

    PubMed 10715260

  • 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.

    PubMed 14744954

  • 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.

    PubMed 21606084

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Optimized echo-guided CRT pacing and normal RV pacing in people with Congestive Heart Failure and Atrial Fibrillation, run by Azienda USL Reggio Emilia - IRCCS at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00111527, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.

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