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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier:
NCT00111527
First received: May 20, 2005
Last updated: March 22, 2010
Last verified: March 2010
  Purpose

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)

Condition Intervention Phase
Congestive Heart Failure
Atrial Fibrillation
Other: Optimized echo-guided CRT pacing
Other: normal RV pacing
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Assessment of the Echo-guided Optimal Cardiac Resynchronization Therapy in Patients Undergoing 'Ablate And Pace' Therapy for Permanent Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Arcispedale Santa Maria Nuova-IRCCS:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The evaluation of the predictive value of echo desynchronisation indexes (inter and intra-LV delays) for identification of clinical failure (see above) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Cost-benefit comparison of the 2 pacing strategies [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 458
Study Start Date: May 2005
Study Completion Date: March 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Normal RV pacing
Other: normal RV pacing
PM or ICD implant according to patient indication
Experimental: 2
Echo-guided optimization of pacing
Other: Optimized echo-guided CRT pacing
Echo-TDI guided VV-delay optimization

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111527

Locations
Italy
Michele Brignole
Lavagna, Genova, Italy, 16033
Arcispedale S Maria Nuova
Reggio Emilia, Italy, 42100
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
Medtronic
Investigators
Principal Investigator: Michele Brignole, MD Ospedali del Tigullio, Lavagna, Italy
Principal Investigator: Carlo Menozzi, MD Ospedale S Maria Nuova, Reggio Emilia, Italy
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michele Brignole, Ospedali del Tigullio
ClinicalTrials.gov Identifier: NCT00111527     History of Changes
Other Study ID Numbers: 1893A
Study First Received: May 20, 2005
Last Updated: March 22, 2010
Health Authority: Italy: Ministry of Health

Keywords provided by Arcispedale Santa Maria Nuova-IRCCS:
Heart failure
Atrial fibrillation
Cardiac resynchronization
Cardiac pacing
Catheter ablation
Quality of life
Echocardiography

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014