Atrial Fibrillation Clinical Trial
Official title:
Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)
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.
Status | Not yet recruiting |
Enrollment | 2312 |
Est. completion date | May 2030 |
Est. primary completion date | February 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Several sites | Multiple Locations | |
Canada | Several sites | Multiple Locations | |
Germany | Several sites | Multiple Locations | |
Netherlands | Several sites | Multiple Locations | |
United Kingdom | Several sites | Multiple Locations |
Lead Sponsor | Collaborator |
---|---|
Atrial Fibrillation Network |
Australia, Canada, Germany, Netherlands, United Kingdom,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Number of nights spent in hospital | Throughout study completion, estimated at a mean of 4 years | ||
Secondary | 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 | ||
Secondary | All-cause death | Throughout study completion, estimated at a mean of 4 years | ||
Secondary | Serious adverse events related to AF therapy | Throughout study completion, estimated at a mean of 4 years | ||
Secondary | Time from randomisation to first cardiovascular hospitalisation | Throughout study completion, estimated at a mean of 4 years | ||
Secondary | Number of cardiovascular hospitalisations (over-night stay) | Throughout study completion, estimated at a mean of 4 years | ||
Secondary | Changes in left ventricular ejection fraction | comparing baseline with 24 months follow up (FU) | ||
Secondary | Changes in quality of life | assessed by EQ-5D-5L | comparing baseline with 12 and 24 months FU | |
Secondary | Changes in quality of life | assessed by AFEQT | comparing baseline with 12 and 24 months FU | |
Secondary | Changes in cognitive function | assessed by Montreal-Cognitive-Assessment-Test | comparing baseline with 24 months FU | |
Secondary | Cardiac rhythm status | sinus rhythm compared to AF | at 12 and 24 months FU | |
Secondary | AF pattern | at 12 and 24 months FU | ||
Secondary | Time from randomisation to first clinical recurrence of AF | Throughout study completion, estimated at a mean of 4 years | ||
Secondary | Time from randomisation to first progression of AF | i. e. from paroxysmal to persistent or longstanding persistent or permanent and each of these components | Throughout study completion, estimated at a mean of 4 years |
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