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

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy
Sponsored by
Cardioangiologisches Centrum Bethanien
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring catheter ablation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Klinik für Elektrophysiologie/Rhythmologie - Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität BochumRecruiting
  • Cardioangiologisches Centrum BethanienRecruiting
  • Universitätsmedizin GreifswaldRecruiting
  • Universitäres Herz- und Gefäßzentrum UKE HamburgRecruiting
  • Universitätsklinikum KölnRecruiting
  • Universitätsklinikum Schleswig HolsteinRecruiting
  • Universitäts Klinikum UlmRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Substrate Modification

LAA Isolation

Arm 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.

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.

Outcomes

Primary Outcome Measures

Arrhythmia Recurrence
Freedom from AF/AT

Secondary Outcome Measures

Incidence of periprocedural complications
Incidence of periprocedural complications such as cardiac perforation, thromboembolic events or bleeding
Number of electrical cardioversions and hospitalizations
Number of electrical cardioversions and hospitalizations

Full Information

First Posted
August 12, 2019
Last Updated
April 8, 2022
Sponsor
Cardioangiologisches Centrum Bethanien
Collaborators
Medtronic, CRO Kottmann
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1. Study Identification

Unique Protocol Identification Number
NCT04056390
Brief Title
Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences
Acronym
ASTRO AF
Official Title
Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardioangiologisches Centrum Bethanien
Collaborators
Medtronic, CRO Kottmann

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
catheter ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Substrate Modification
Arm Type
Active Comparator
Arm 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.
Arm Title
LAA Isolation
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy
Intervention Description
Substrate ablation in terms of voltage abatement versus electrical left atrial appendage isolation.
Primary Outcome Measure Information:
Title
Arrhythmia Recurrence
Description
Freedom from AF/AT
Time Frame
Day 91-365 after index ablation
Secondary Outcome Measure Information:
Title
Incidence of periprocedural complications
Description
Incidence of periprocedural complications such as cardiac perforation, thromboembolic events or bleeding
Time Frame
day 0 - day 365
Title
Number of electrical cardioversions and hospitalizations
Description
Number of electrical cardioversions and hospitalizations
Time Frame
day0 - day 365

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boris Schmidt, MD
Phone
004969945028
Ext
0
Email
b.schmidt@ccb.de
First Name & Middle Initial & Last Name or Official Title & Degree
Bojana Languille
Phone
004969945028
Ext
144
Email
b.languille@ccb.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Schmidt, MD
Organizational Affiliation
Cardioangiologisches Centrum Bethanien
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Elektrophysiologie/Rhythmologie - Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität Bochum
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp Sommer, Prof. Dr.
Phone
+49 (0) 5731-97-3380
Email
psommer@hdz-nrw.de
First Name & Middle Initial & Last Name & Degree
Anke Schmidt, Dipl.-Ing.
Phone
+49 (0) 5731-97-2429
Email
anschmidt@hdz-nrw.de
Facility Name
Cardioangiologisches Centrum Bethanien
City
Frankfurt/Main
ZIP/Postal Code
60431
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boris Schmidt, Dr.
Phone
+4969945028
Ext
110
Email
b.schmidt@ccb.de
First Name & Middle Initial & Last Name & Degree
Boris Schmidt, Dr.
Facility Name
Universitätsmedizin Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathias Busch, Dr. med.
Email
mathias.busch@uni-greifswald.de
First Name & Middle Initial & Last Name & Degree
Doreen Kniephoff
Email
Doreen.Kniephoff@med.uni-greifswald.de
Facility Name
Universitäres Herz- und Gefäßzentrum UKE Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Metzner, PD Dr. med.
Phone
+49 (0) 40 7410 - 58320
Email
a.metzner@uke.de
First Name & Middle Initial & Last Name & Degree
Anke Heiermann
Email
a.heiermann@uke.de
Facility Name
Universitätsklinikum Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Steven, Univ.-Prof. Dr.
Email
daniel.steven@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Terentieva
Phone
0221/478-88272
Email
rhythmologie@uk-koeln.de
Facility Name
Universitätsklinikum Schleswig Holstein
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rolan R Tilz, MD
Phone
+49 451 500
Ext
44580
Email
Roland.Tilz@uksh.de
Facility Name
Universitäts Klinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tillman Dahme, PD Dr. med
Phone
+49 (0)731 500-45230
Email
tillman.dahme@uniklinik-ulm.de
First Name & Middle Initial & Last Name & Degree
Beate Polte
Phone
+49 (0)731-500-45232
Email
beate.polte@uniklinik-ulm.de

12. IPD Sharing Statement

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Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences

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