Pulsed-field Ablation for Patients With Asymptomatic Non-paroxysmal Atrial Fibrillation

NCT06166524 | Unknown Phase 2 DMC

• 1 other identifier: PF-A-SYMPTOMATIC
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to test the hypothesis whether the treatment of patients with asymptomatic non-paroxysmal AF based on catheter ablation will be superior than conservative approach consisting of electrical cardioversion with AADs treatment in terms of significant improvement of functional exercise capacity. Secondary hypothesis is that mild functional improvement would be present also by achieving optimum heart rate by means of the titration of beta-blocker dose. Patients with non-paroxysmal asymptomatic AF will be enrolled and randomized to either early invasive strategy arm (EIS;, i.e. catheter ablation), or conservative arm (CS; ie. cardioversion followed by antiarrhythmic drug treatment. As baseline examinations, functional cardiopulmonary exercise testing (CPET), Holter, recording, and echocardiography will be done. After one month, the procedure (catheter ablation or cardioversion) will be performed. Outpatients visits are scheduled at 3, 6, 9 and 12 months after the randomization. At each visit, ECG Holter recording will be done. CPET will be repeated at M3 and M12 visits. In patients in the CS arm with AF recurrence, the dose of BB will be optimized using smart watches (the goal \< 110/min on average, but to achieve 75% of predicted maximum heart rate). The endpoint will be the change in VO2 max between baseline and 12M CPET. Secondary endpoints will be AF burden, AF freedom, the change in the concentration of NT-proBNP, the change in the left atrial diameter and left ventricular ejection fraction, the proportion of patients with no improvement while in SR, and the improvement in the quality-of-life at 12 months.

Conditions

Atrial Fibrillation; Pulsed-field Ablation; Functional Exercise Testing

Outcome Measures

Primary Outcomes (1)

• Changes in VO2 max

  The change in VO2 max during baseline and 12 month functional CardioPulmonary Exercise Testing

  12 months

Secondary Outcomes (6)

• Sinus rhythm maintenance

  12 monthhs

• AF burden

  12 months

• Proportion of really asymptomatic patients

  12 months

• VO2 max change in patients with atrial fibrillation reoccurrence

  12 months

• NT-pro BNP

  12 months

Study Arms (2)

Early invasive strategy

ACTIVE COMPARATOR

Patients will undergo early catheter ablation for atrial fibrillation using pulsed-field ablation energy

Procedure: Catheter ablation for atrial fibrillation using pulsed-field energy

Conservative arm

PLACEBO COMPARATOR

Patients will undergo cardioversion with antiarrhythmic drug treatment. In patients with atrial fibrillation reoccurrence, an optimalization of bradycardia medication will be done using smart watches heart rate monitoring

Procedure: Conservative arm

Interventions

Catheter ablation for atrial fibrillation using pulsed-field energy PROCEDURE

Patients will undergo pulmonary vein isolation using pulsed-field energy

Early invasive strategy

Conservative arm PROCEDURE

Patients will undergo electrical cardioversion with consequent treatment with antiarrhythmic drugs

Conservative arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-paroxysmal AF
• absence of symptoms during standard clinical evaluation
• AFEQT\> 80
• NT-pro BNP \< 800 pg/mL

You may not qualify if:

• significant valvular disease
• left ventricular dysfunction - LV EF \< 50 %
• history of tachycardia - induced cardiomyopathy
• pulmonary hypertension (sPAP \> 40 mm Hg)
• age \> 75 years
• LA size \> 60 mm
• physical limitations that don't enable functional cardiopulmonary exercise testing
• overt coronary artery disease
• pregnancy
• BMI \> 40
• chronic obstructive pulmonary disease with moderate or severe obstruction
• life expectancy less than 2 years
• permanent AF
• ophthalmological medication (eye drops) containing beta-blockers

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Regional Hospital Liberec: collaborator
• Nemocnice AGEL Trinec-Podlesi a.s.: collaborator
• Brno University Hospital: collaborator
• University Hospital Ostrava: collaborator
• VFN: collaborator

Study Sites (1)

Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

Location

Related Publications (3)

• Kirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan A, Fetsch T, van Gelder IC, Haase D, Haegeli LM, Hamann F, Heidbüchel 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

  RESULT

• Fiala M, Bulkova V, Sknouril L, Nevralova R, Toman O, Januska J, Spinar J, Wichterle D. Functional improvement after successful catheter ablation for long-standing persistent atrial fibrillation. Europace. 2017 Nov 1;19(11):1781-1789. doi: 10.1093/europace/euw282.

  PMID: 27707782 RESULT

• Wokhlu A, Monahan KH, Hodge DO, Asirvatham SJ, Friedman PA, Munger TM, Bradley DJ, Bluhm CM, Haroldson JM, Packer DL. Long-term quality of life after ablation of atrial fibrillation the impact of recurrence, symptom relief, and placebo effect. J Am Coll Cardiol. 2010 May 25;55(21):2308-16. doi: 10.1016/j.jacc.2010.01.040.

  PMID: 20488300 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Pavel Osmančík

  Cardiac center University Hospital Kralovske Vinohrady

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pavel Osmančík

CONTACT

721544447; pavel.osmancik@gmail.com

Dalibor Herman

CONTACT

267163029; dalibor.herman@fnkv.cz

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: December 12, 2023
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: December 12, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data will be available six months after study publication

Locations

CZ (1)