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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06324188




Registration number
NCT06324188
Ethics application status
Date submitted
4/03/2024
Date registered
21/03/2024
Date last updated
17/10/2024

Titles & IDs
Public title
Early Atrial Fibrillation Ablation for Stroke Prevention in Patients with High Comorbidity Burden (EASThigh-AFNET 11)
Scientific title
Early Atrial Fibrillation Ablation for Stroke Prevention in Patients with High Comorbidity Burden (EASThigh-AFNET 11)
Secondary ID [1] 0 0
EASThigh-AFNET 11
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Early atrial fibrillation ablation
Other interventions - Usual Care

Other: Early atrial fibrillation ablation -

Other: Usual Care -


Other interventions: Early atrial fibrillation ablation
Patients randomised to early atrial fibrillation ablation will undergo pulmonary vein isolation within 2 months after randomisation.

Other interventions: Usual Care
Usual care will consist of optimal AF therapy based on guideline recommendations and local protocols and usage.The choice of therapies and medications follows routine care in line with medical guidelines and local policies at the discretion of the treating physician and should be based on the individual medical status of each study patient.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of cardiovascular complications related to AF
Timepoint [1] 0 0
Throughout study completion, estimated at a mean of 4 years
Primary outcome [2] 0 0
The primary safety outcome is a composite of all-cause death and serious complications of AF therapy.
Timepoint [2] 0 0
Throughout study completion, estimated at a mean of 4 years
Secondary outcome [1] 0 0
Number of nights spent in hospital
Timepoint [1] 0 0
Throughout study completion, estimated at a mean of 4 years
Secondary outcome [2] 0 0
Time from randomisation to first occurrence of each of the individual components of the primary outcome
Timepoint [2] 0 0
Throughout study completion, estimated at a mean of 4 years
Secondary outcome [3] 0 0
All-cause death
Timepoint [3] 0 0
Throughout study completion, estimated at a mean of 4 years
Secondary outcome [4] 0 0
Serious adverse events related to AF therapy
Timepoint [4] 0 0
Throughout study completion, estimated at a mean of 4 years
Secondary outcome [5] 0 0
Time from randomisation to first cardiovascular hospitalisation
Timepoint [5] 0 0
Throughout study completion, estimated at a mean of 4 years
Secondary outcome [6] 0 0
Number of cardiovascular hospitalisations (over-night stay)
Timepoint [6] 0 0
Throughout study completion, estimated at a mean of 4 years
Secondary outcome [7] 0 0
Changes in left ventricular ejection fraction
Timepoint [7] 0 0
comparing baseline with 24 months follow up (FU)
Secondary outcome [8] 0 0
Changes in quality of life
Timepoint [8] 0 0
comparing baseline with 12 and 24 months FU
Secondary outcome [9] 0 0
Changes in quality of life
Timepoint [9] 0 0
comparing baseline with 12 and 24 months FU
Secondary outcome [10] 0 0
Changes in cognitive function
Timepoint [10] 0 0
comparing baseline with 24 months FU
Secondary outcome [11] 0 0
Cardiac rhythm status
Timepoint [11] 0 0
at 12 and 24 months FU
Secondary outcome [12] 0 0
AF pattern
Timepoint [12] 0 0
at 12 and 24 months FU
Secondary outcome [13] 0 0
Time from randomisation to first clinical recurrence of AF
Timepoint [13] 0 0
Throughout study completion, estimated at a mean of 4 years
Secondary outcome [14] 0 0
Time from randomisation to first progression of AF
Timepoint [14] 0 0
Throughout study completion, estimated at a mean of 4 years

Eligibility
Key inclusion criteria
I1. AF first diagnosed within 2 years prior to enrolment and documented in body surface ECG

I2. High comorbidity estimated by CHA2DS2-VASc score of 4 or more

I3. Patient suitable for ablation using cryoballoon ablation systems from Medtronic

I4. Age = 18 years

I5. Provision of signed informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
General exclusion criteria

E1. Any disease that limits life expectancy to less than 1 year.

E2. Participation in another clinical trial, either within the 3 months prior to enrolment or still on-going (participation in potential sub-studies connected to this trial is permitted).

E3. Previous participation in EASThigh-AFNET 11.

E4. Pregnant women.

E5. Breastfeeding women.

E6. Drug abuse or clinically manifest alcohol abuse.

Exclusion criteria related to a cardiac condition

E7. Prior AF ablation or surgical therapy of AF.

E8. Patients not suitable for AF ablation.

E9. Patients with a history of stroke which occurred within 3 months prior to enrolment.

E10. Valve disease requiring specific therapy.

Exclusion criteria based on laboratory abnormalities

E11. Clinically manifested thyroid dysfunction requiring therapy.

Study design
Purpose of the study
Prevention
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2030
Actual
Sample size
Target
2312
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Several sites - Multiple Locations
Recruitment postcode(s) [1] 0 0
- Multiple Locations
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Multiple Locations
Country [2] 0 0
Germany
State/province [2] 0 0
Multiple Locations
Country [3] 0 0
Netherlands
State/province [3] 0 0
Multiple Locations
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Multiple Locations

Funding & Sponsors
Primary sponsor type
Other
Name
Atrial Fibrillation Network
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial).

The objective of EASThigh-AFNET 11 is to investigate whether early atrial fibrillation ablation in patients with atrial fibrillation (AF) and a high comorbidity burden (CHA2DS2-VASc =4) reduces cardiovascular events (stroke, cardiovascular death, or heart failure events) compared to usual care.
Trial website
https://clinicaltrials.gov/study/NCT06324188
Trial related presentations / publications
Kirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan A, Fetsch T, van Gelder IC, Haase D, Haegeli LM, Hamann F, Heidbuchel H, Hindricks G, Kautzner J, Kuck KH, Mont L, Ng GA, Rekosz J, Schoen N, Schotten U, Suling A, Taggeselle J, Themistoclakis S, Vettorazzi E, Vardas P, Wegscheider K, Willems S, Crijns HJGM, Breithardt G; EAST-AFNET 4 Trial Investigators. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. 2020 Oct 1;383(14):1305-1316. doi: 10.1056/NEJMoa2019422. Epub 2020 Aug 29.
Rillig A, Borof K, Breithardt G, Camm AJ, Crijns HJGM, Goette A, Kuck KH, Metzner A, Vardas P, Vettorazzi E, Wegscheider K, Zapf A, Kirchhof P. Early Rhythm Control in Patients With Atrial Fibrillation and High Comorbidity Burden. Circulation. 2022 Sep 13;146(11):836-847. doi: 10.1161/CIRCULATIONAHA.122.060274. Epub 2022 Aug 15.
Eckardt L, Sehner S, Suling A, Borof K, Breithardt G, Crijns H, Goette A, Wegscheider K, Zapf A, Camm J, Metzner A, Kirchhof P. Attaining sinus rhythm mediates improved outcome with early rhythm control therapy of atrial fibrillation: the EAST-AFNET 4 trial. Eur Heart J. 2022 Oct 21;43(40):4127-4144. doi: 10.1093/eurheartj/ehac471.
Andrade JG, Wells GA, Deyell MW, Bennett M, Essebag V, Champagne J, Roux JF, Yung D, Skanes A, Khaykin Y, Morillo C, Jolly U, Novak P, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Lauck S, Macle L, Verma A; EARLY-AF Investigators. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):305-315. doi: 10.1056/NEJMoa2029980. Epub 2020 Nov 16.
Andrade JG, Deyell MW, Macle L, Wells GA, Bennett M, Essebag V, Champagne J, Roux JF, Yung D, Skanes A, Khaykin Y, Morillo C, Jolly U, Novak P, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Lauck S, Cadrin-Tourigny J, Kochhauser S, Verma A; EARLY-AF Investigators. Progression of Atrial Fibrillation after Cryoablation or Drug Therapy. N Engl J Med. 2023 Jan 12;388(2):105-116. doi: 10.1056/NEJMoa2212540. Epub 2022 Nov 7.
Dickow J, Kirchhof P, Van Houten HK, Sangaralingham LR, Dinshaw LHW, Friedman PA, Packer DL, Noseworthy PA, Yao X. Generalizability of the EAST-AFNET 4 Trial: Assessing Outcomes of Early Rhythm-Control Therapy in Patients With Atrial Fibrillation. J Am Heart Assoc. 2022 Jun 7;11(11):e024214. doi: 10.1161/JAHA.121.024214. Epub 2022 May 27.
Dickow J, Kany S, Roth Cardoso V, Ellinor PT, Gkoutos GV, Van Houten HK, Kirchhof P, Metzner A, Noseworthy PA, Yao X, Rillig A. Outcomes of Early Rhythm Control Therapy in Patients With Atrial Fibrillation and a High Comorbidity Burden in Large Real-World Cohorts. Circ Arrhythm Electrophysiol. 2023 May;16(5):e011585. doi: 10.1161/CIRCEP.122.011585. Epub 2023 Mar 21.
Public notes

Contacts
Principal investigator
Name 0 0
Paulus Kirchhof, Prof. Dr.
Address 0 0
University Heart and Vascular Center Hamburg, University Hospital Hamburg Eppendorf
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Antje Albring, Dr.
Address 0 0
Country 0 0
Phone 0 0
+49 251 980 1330
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06324188