Clinical trial NCT04056390: Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences
Official title: Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: catheter ablation
Lead sponsor: Cardioangiologisches Centrum Bethanien
Sponsor class: OTHER
Collaborators: name: Medtronic
name: CRO Kottmann
First posted: 2019-08-14
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Arrhythmia Recurrence
timeFrame: Day 91-365 after index ablation
Secondary outcomes:
measure: Incidence of periprocedural complications
timeFrame: day 0 - day 365
measure: Number of electrical cardioversions and hospitalizations
timeFrame: day0 - day 365
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Klinik für Elektrophysiologie/Rhythmologie - Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität Bochum
city: Frankfurt/Main
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum UKE Hamburg
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig Holstein
city: Ulm
country: Germany
facility: Universitäts Klinikum Ulm
Study officials:
affiliation: Cardioangiologisches Centrum Bethanien
name: Boris Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References: