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Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences (ASTRO AF)

C

Cardioangiologisches Centrum Bethanien

Status

Active, not recruiting

Conditions

Atrial Fibrillation

Treatments

Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04056390
SF124/2017

Details and patient eligibility

About

The aim of the study is to evaluate different ablation strategies in patients with AF recurrences despite chronic PVI after prior catheter ablation.

The present study is a multi-centre prospective randomized study enrolling 256 patients with drug-refractory AF despite previous AF ablation.

After PV remapping confirming durable PVI patients will be assigned to 2 different groups: Group A: Substrate modification.

After obtaining a voltage map of the LA, substrate modification will be performed aiming at low-voltage areas (LVA) < 0.5mV.

Group B: LAA isolation. Patients will undergo LAA-isolation using the cryoballoon (CB). Catheter ablation procedures will be performed with commercially available devices including 3D mapping systems (CARTO, EnSite) and irrigated radiofrequency current (RFC) ablation or cryothermal balloon ablation (Arctic Front Advance).

The primary endpoint is freedom from documented recurrence of AF or any atrial tachyarrhythmia lasting > 30 seconds between day 91 and 365 after the index procedure.

Enrollment

256 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • • Symptomatic non-valvular atrial fibrillation despite prior ablation with an indication for re-ablation according to current guidelines.

    • Permanent pulmonary vein isolation according to mapping with a spiral mapping catheter
    • Age 18-85 years.
    • Left atrial size < 55mm.
    • Left ventricular ejection fraction ≥ 45%.
    • Patient is able to provide informed consent and is willing to comply with the study protocol.

Exclusion criteria

  • Contraindications for repeat ablation
  • Reconnected pulmonary veins according to mapping results with a spiral mapping catheter
  • Minimal diameter of LAA neck ≥25mm
  • History of mitral valve surgery
  • Severe mitral valve regurgitation
  • Inability to be treated with oral anticoagulation
  • Presence of intracardiac thrombi
  • Chronic obstructive pulmonary disease treated with long acting bronchodilatators
  • Asthma
  • Obstructive sleep apnea syndrome
  • Pregnancy
  • Participation in other clinical studies
  • Unwilling to follow the study protocol and to attend follow-up visits

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

256 participants in 2 patient groups

Substrate Modification
Active Comparator group
Description:
After obtaining a voltage map of the LA, substrate modification by catheter ablation using an irrigated radio frequency current ablation catheter will be performed aiming at low-voltage areas (LVA) \< 0.5mV.
Treatment:
Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy
LAA Isolation
Active Comparator group
Description:
Patients will undergo LAA-isolation using the cryoballoon (CB). Six weeks later patients will undergo re-mapping. In case of residual conduction LAA-reisolation will be performed. In case of durable LAA isolation, interventional LAA occlusion is recommended.
Treatment:
Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy

Trial contacts and locations

7

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Central trial contact

Boris Schmidt, MD; Bojana Languille

Data sourced from clinicaltrials.gov

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