Cardiac Resynchronisation Therapy and AV Nodal Ablation Trial in Atrial Fibrillation Patients (CAAN-AF)

NCT01522898 | Completed DMC

• 1 other identifier: RAH-HREC-Protocol-#111234
• Study Type: interventional
• Target: 145
• Locations: 5 countries
• Sites: 33

Brief Summary

Cardiac resynchronization therapy (CRT) is a treatment for heart failure in patients who also suffer from ventricular dyssynchrony, a form of uncoordinated contraction of the ventricle (lower pumping chamber of the heart). In the past decade, CRT has become an established treatment for heart failure patients who are in normal rhythm, called sinus rhythm. An important subset of heart failure patients are those with atrial fibrillation (AF), who make up around 1 in 4 HF patients, and are over-represented amongst HF patients with more advanced symptoms. In heart failure patients with AF, CRT has proven not to be as effective as in sinus rhythm, due to competition between beats generated by the CRT device and beats conducted from the heart's own electrical conduction system. In the current study, we aim to test the hypothesis that ablating the AV node, which controls electrical conduction from the heart's atria (top chamber) to its ventricles (lower chambers), will improve survival and heart failure symptoms in CRT patients with co-existent AF. The results are important, because they will provide a way of passing on the benefits of CRT, such as improved survival, less heart failure symptoms, and better quality of life, to heart failure patients who also suffer from AF.

Conditions

Heart Failure; Atrial Fibrillation

Keywords

Heart Failure; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• All-cause mortality and non-fatal heart failure events

  This is a composite of all-cause mortality and non-fatal heart failure events. All-cause mortality will be determined by a designated clinical events committee. Heart Failure events will be documented by clinical data from the hospital In CAAN-AF, a subject will be described as having a "Heart Failure Event" when the subject has symptoms and/or signs consistent with congestive heart failure and: * responsive to parenteral diuretic or inotropic support as an outpatient * responsive to oral or parenteral diuretic or inotropic support during an inpatient stay

  Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)

Secondary Outcomes (7)

• All-cause mortality

  Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)f recruitment

• Cardiovascular mortality

  Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)

• Non-Fatal Heart Failure Events

  Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)

• 6-minute walking distance

  Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)

• Quality of Life questionnaires

  Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)

Other Outcomes (4)

• Inappropriate shocks

  Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)

• Cardiovascular MRI prediction of response

  Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)

• Depression

  Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)

Study Arms (2)

Medical Rate Control

ACTIVE COMPARATOR

Medical Rate Control aimed at ventricular rate target of 90 beats per minute. Specific medical therapy to be determined for each patient by individual clinician.

Drug: Medical Ventricular Rate Control

AV nodal ablation

EXPERIMENTAL

AV node ablation performed by percutaneous catheter ablation, with endpoint of complete heart block.

Procedure: AV nodal ablation

Interventions

AV nodal ablation PROCEDURE

Percutaneous catheter ablation of the AV node.

Also known as: His Bundle Ablation, AV junctional ablation

AV nodal ablation

Medical Ventricular Rate Control DRUG

Ventricular Rate Control with target ventricular rate of 90 beats per minute.

Medical Rate Control

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old
• Persistent (≥ 1 month) or permanent atrial fibrillation. Persistent AF will be where obtaining and maintaining sinus rhythm is deemed either not worthwhile, or to be ineffective in the long term, or where both the patient and physician accept the presence of AF, where rhythm control intervention is, by definition no longer pursued. Permanent AF is defined as atrial fibrillation where sinus rhythm cannot be restored.
• NYHA class II , III or ambulatory class IV heart failure
• Left Ventricular Ejection Fraction (LVEF) ≤ 35% by objective criteria such as echocardiography, or cardiac MRI
• QRS duration on 12-lead ECG ≥ 120ms
• Able and willing to comply with all pre-, post- and follow-up testing and requirements.

You may not qualify if:

• age \< 18 years
• pregnancy
• previous AV nodal ablation
• Second or third degree AV block
• Inability to provide informed consent
• life expectancy less than 24 months due to co-morbid illness other than heart failure erg cancer, end-stage renal disease, liver failure
• Paroxysmal Atrial Fibrillation that self terminates within 7 days

Sponsors & Collaborators

• University of Adelaide: lead
• Medtronic: collaborator
• Abbott Medical Devices: collaborator
• Boston Scientific Corporation: collaborator

Study Sites (33)

Canberra Hospital

Canberra, Australian Capital Territory, 2605, Australia

Location

Concord Hospital

Concord, New South Wales, Australia

Location

John Hunter Hospital

New Lambton, New South Wales, 2305, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Location

Fiona Stanley

Murdoch, Perth, WA, 6150, Australia

Location

Royal Brisbane Hospital

Brisbane, Queensland, 4209, Australia

Location

Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Townsville Hospital and Health Service

Douglas, Queensland, 4814, Australia

Location

Gold Coast University Hospital

Southport, Queensland, 4213, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Geelong Hospital

Geelong, Victoria, 3220, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Melbourne Private Hospital

Melbourne, Victoria, Australia

Location

The Alfred Hospital

Melbourne, Victoria, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Sir Charles Gairdner Hospital

Perth, Western Australia, 6009, Australia

Location

Royal Perth Hospital

Perth, Western Australia, Australia

Location

Universitätsmedizin Mainz

Mainz, Gebäude 401/k, 55131, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Martinistr. 52 Gebäude Ost 50, 8. OG, Raum 842, 20246, Germany

Location

University Clinic of Cologne

Cologne, D-50936, Germany

Location

Asklepios Hospital

St. Georg, 20099, Germany

Location

National Heart Institute

Kuala Lumpur, 50400, Malaysia

Location

Tauranga Hospital

Tauranga, Bay of Plenty, 3143, New Zealand

Location

Auckland City Hospital

Auckland, 1142, New Zealand

Location

Waikato Hospital

Hamilton, 3240, New Zealand

Location

Wellington Hospital

Wellington, 6021, New Zealand

Location

James Cook University Hospital

Middlesbrough, United Kingdom

Location

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

• Prashanthan Sanders, MBBS PhD

  University of Adelaide

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: February 1, 2012
• Study Start: March 1, 2013
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

MY (1); AU (23); DE (4); NZ (4); GB (1)