Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)

NCT06324188 | Recruiting DMC

• 1 other identifier: EASThigh-AFNET 11
• Study Type: interventional
• Target: 2,312
• Locations: 7 countries
• Sites: 7

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.

Conditions

Atrial Fibrillation

Keywords

Early atrial fibrillation ablation; High comorbidity burden; CHA2DS2-VASc score; Early rhythm control; Stroke; Heart failure; Cardiovascular death; Cryoballoon

Outcome Measures

Primary Outcomes (2)

• Composite of cardiovascular complications related to AF

  It is defined as time from randomisation to the first occurrence of a composite of cardiovascular death, stroke (either ischemic or hemorrhagic), or hospitalisation for worsening of heart failure.

  Throughout study completion, estimated at a mean of 4 years

• The primary safety outcome is a composite of all-cause death and serious complications of AF therapy.

  Serious Adverse Events (SAEs), including primary and secondary outcome parameters if based on clinical events, will be adjudicated by the independent Clinical Event Committee (CEC) according to standardised definitions given in the CEC charter.

  Throughout study completion, estimated at a mean of 4 years

Secondary Outcomes (14)

• Number of nights spent in hospital

  Throughout study completion, estimated at a mean of 4 years

• Time from randomisation to first occurrence of each of the individual components of the primary outcome

  Throughout study completion, estimated at a mean of 4 years

• All-cause death

  Throughout study completion, estimated at a mean of 4 years

• Serious adverse events related to AF therapy

  Throughout study completion, estimated at a mean of 4 years

• Time from randomisation to first cardiovascular hospitalisation

  Throughout study completion, estimated at a mean of 4 years

Study Arms (2)

Early atrial fibrillation ablation

OTHER

Other: Early atrial fibrillation ablation

Usual Care

OTHER

Other: Usual Care

Interventions

Early atrial fibrillation ablation OTHER

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

Early atrial fibrillation ablation

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

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

You may qualify if:

• I1. AF first diagnosed within 5 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 or other ablation systems with comparable efficacy and safety from Medtronic
• I4. Age ≥ 18 years
• I5. Provision of signed informed consent

You may not qualify if:

• 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.
• 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.
• E11. Clinically manifested thyroid dysfunction requiring therapy.

Sponsors & Collaborators

• Atrial Fibrillation Network: lead

Study Sites (7)

Several sites

Multiple Locations, Australia

NOT YET RECRUITING

Several sites

Multiple Locations, Canada

RECRUITING

Several sites

Multiple Locations, Germany

RECRUITING

Several sites

Multiple Locations, Netherlands

RECRUITING

Several sites

Multiple Locations, Poland

RECRUITING

Several sites

Multiple Locations, Spain

RECRUITING

Several sites

Multiple Locations, United Kingdom

NOT YET RECRUITING

Related Publications (7)

• 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.

  PMID: 32865375 BACKGROUND

• 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.

  PMID: 35968706 BACKGROUND

• 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.

  PMID: 36036648 BACKGROUND

• 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.

  PMID: 33197159 BACKGROUND

• 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.

  PMID: 36342178 BACKGROUND

• 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.

  PMID: 35621202 BACKGROUND

• 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.

  PMID: 36942567 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Paulus Kirchhof, Prof. Dr.

  University Heart and Vascular Center Hamburg, University Hospital Hamburg Eppendorf

  STUDY DIRECTOR

• Andreas Rillig, PD Dr.

  University Heart and Vascular Center Hamburg, University Hospital Hamburg Eppendorf

  STUDY DIRECTOR

• Jason Andrade, Prof. Dr.

  University of British Columbia, Vancouver General Hospital, Department of Electrophysiology

  PRINCIPAL INVESTIGATOR

• André Ng, Prof. Dr.

  Department of Cardiovascular Sciences, University of Leicester

  PRINCIPAL INVESTIGATOR

• Prash Sanders, Prof. Dr.

  Centre for Heart Rhythm Disorders, University of Adelaide, Royal Adelaide Hospital

  PRINCIPAL INVESTIGATOR

• Volker Straub

  Patient representative

  PRINCIPAL INVESTIGATOR

• Kevin Vernooy, Prof. Dr.

  Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center (MUMC)

  PRINCIPAL INVESTIGATOR

• Antonia Zapf, Prof. Dr.

  Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antje Albring, Dr.

CONTACT

+49 251 980 1330; easthigh@af-net.eu

Anna-Katharina Quade

CONTACT

+49 251 980 1330; easthigh@af-net.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: blinded endpoint assessment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 21, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: January 8, 2026

Record last verified: 2025-11

Locations

DE (1); ES (1); GB (1); PL (1); CA (1); NL (1); AU (1)