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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01522898




Registration number
NCT01522898
Ethics application status
Date submitted
25/01/2012
Date registered
1/02/2012
Date last updated
13/11/2020

Titles & IDs
Public title
Cardiac Resynchronisation Therapy and AV Nodal Ablation Trial in Atrial Fibrillation Patients (CAAN-AF)
Scientific title
Cardiac Resynchronisation Therapy and AV Nodal Ablation Trial in Atrial Fibrillation
Secondary ID [1] 0 0
RAH-HREC-Protocol-#111234
Universal Trial Number (UTN)
Trial acronym
CAAN-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - AV nodal ablation
Treatment: Drugs - Medical Ventricular Rate Control

Active comparator: Medical Rate Control - 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.

Experimental: AV nodal ablation - AV node ablation performed by percutaneous catheter ablation, with endpoint of complete heart block.


Treatment: Surgery: AV nodal ablation
Percutaneous catheter ablation of the AV node.

Treatment: Drugs: Medical Ventricular Rate Control
Ventricular Rate Control with target ventricular rate of 90 beats per minute.
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause mortality and non-fatal heart failure events
Timepoint [1] 0 0
Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)
Secondary outcome [1] 0 0
All-cause mortality
Timepoint [1] 0 0
Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)f recruitment
Secondary outcome [2] 0 0
Cardiovascular mortality
Timepoint [2] 0 0
Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)
Secondary outcome [3] 0 0
Non-Fatal Heart Failure Events
Timepoint [3] 0 0
Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)
Secondary outcome [4] 0 0
6-minute walking distance
Timepoint [4] 0 0
Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)
Secondary outcome [5] 0 0
Quality of Life questionnaires
Timepoint [5] 0 0
Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)
Secondary outcome [6] 0 0
Unplanned Hospitalization
Timepoint [6] 0 0
Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)
Secondary outcome [7] 0 0
Ventricular arrhythmias requiring device therapy
Timepoint [7] 0 0
Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2020
Sample size
Target
Accrual to date
Final
145
Recruitment in Australia
Recruitment state(s)
ACT,NSW,Perth, WAQLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Concord Hospital - Concord
Recruitment hospital [3] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [6] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [7] 0 0
Fiona Stanley - Murdoch
Recruitment hospital [8] 0 0
Royal Brisbane Hospital - Brisbane
Recruitment hospital [9] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [10] 0 0
Townsville Hospital and Health Service - Douglas
Recruitment hospital [11] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [12] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [13] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [14] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [15] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [16] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [17] 0 0
Geelong Hospital - Geelong
Recruitment hospital [18] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [19] 0 0
Melbourne Private Hospital - Melbourne
Recruitment hospital [20] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [21] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [22] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment hospital [23] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
2305 - New Lambton
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
2065 - Sydney
Recruitment postcode(s) [6] 0 0
- Sydney
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment postcode(s) [8] 0 0
4209 - Brisbane
Recruitment postcode(s) [9] 0 0
4032 - Chermside
Recruitment postcode(s) [10] 0 0
4814 - Douglas
Recruitment postcode(s) [11] 0 0
4213 - Southport
Recruitment postcode(s) [12] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [13] 0 0
5000 - Adelaide
Recruitment postcode(s) [14] 0 0
5042 - Bedford Park
Recruitment postcode(s) [15] 0 0
7000 - Hobart
Recruitment postcode(s) [16] 0 0
3168 - Clayton
Recruitment postcode(s) [17] 0 0
3220 - Geelong
Recruitment postcode(s) [18] 0 0
3084 - Heidelberg
Recruitment postcode(s) [19] 0 0
- Melbourne
Recruitment postcode(s) [20] 0 0
3050 - Parkville
Recruitment postcode(s) [21] 0 0
6009 - Perth
Recruitment postcode(s) [22] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Gebäude 401/k
Country [2] 0 0
Germany
State/province [2] 0 0
Martinistr. 52 Gebäude Ost 50, 8. OG, Raum 842
Country [3] 0 0
Germany
State/province [3] 0 0
Cologne
Country [4] 0 0
Germany
State/province [4] 0 0
St Georg
Country [5] 0 0
Malaysia
State/province [5] 0 0
Kuala Lumpur
Country [6] 0 0
New Zealand
State/province [6] 0 0
Bay Of Plenty
Country [7] 0 0
New Zealand
State/province [7] 0 0
Auckland
Country [8] 0 0
New Zealand
State/province [8] 0 0
Hamilton
Country [9] 0 0
New Zealand
State/province [9] 0 0
Wellington
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Middlesbrough

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Medtronic
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Abbott Medical Devices
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Boston Scientific Corporation
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01522898
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prashanthan Sanders, MBBS PhD
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01522898