Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
69 participants
INTERVENTIONAL
2019-04-05
2023-04-06
Brief Summary
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Detailed Description
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The data collected within the pilot phase will be reviewed and a decision on extending the trial with an extended number of patients and sites as main phase will be taken.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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CRYO group
Within the CRYO arm the ablation will be performed using the Arctic Front Advance Cardiac CryoAblation Catheter, including next generation systems as applicable and approved by Medtronic for the trial.
Intervention performed: Cryoballoon ablation; Cryoballoon (Arctic Front Advance Cryoballoon)
Cryoballoon (Arctic Front Advance Cryoballoon)
Ablation using a Cryoballoon catheter (Arctic Front Advance Cryoballoon Cardiac Ablation Catheter)
RF group
Within the RF arm the ablation will be performed using a catheter out of the ThermoCool Smarttouch catheter family, including next generation contact force systems as applicable.
Intervention performed: Radiofrequency ablation; Radiofrequency Catheter (ThermoCool Smarttouch)
Radiofrequency Catheter (ThermoCool Smarttouch)
Ablation using a Radiofrequency ablation catheter (ThermoCool Smarttouch catheter)
Interventions
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Cryoballoon (Arctic Front Advance Cryoballoon)
Ablation using a Cryoballoon catheter (Arctic Front Advance Cryoballoon Cardiac Ablation Catheter)
Radiofrequency Catheter (ThermoCool Smarttouch)
Ablation using a Radiofrequency ablation catheter (ThermoCool Smarttouch catheter)
Eligibility Criteria
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Inclusion Criteria
* Date of first diagnosis of persistent AF within the last 12 months preceding the date of screening
* Documented treatment failure or intolerance of at least one Class I or Class III antiarrhythmic drug
Exclusion Criteria
* Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
* History of right atrial flutter, not ablated prior to enrollment
* Any cardiac surgery, myocardial infarction, percutaneous coronary intervention or coronary artery stenting which occurred within the 3 months before the eligibility assessment
* Unstable angina pectoris
* Primary pulmonary hypertension
* Any condition contraindicating chronic anticoagulation
* Any cerebral ischemic event (stroke or transient ischemic attack \[TIA\]) which occurred within the 6 months before the consent date
* Presence of any cardiac prosthetic valves
* Long-standing persistent AF lasting for ≥ 1 year (even when it is decided to adopt a rhythm control strategy)
* New York Health Association (NYHA) class III or IV heart failure and/or documented left ventricular ejection fraction (LVEF) \< 40% measured by acceptable cardiac testing (e.g. TTE)
* Acute cardiac condition, including endocarditis, pericarditis or pericardial effusion
* Presence or likely implant of a permanent pacemaker, biventricular pacemaker or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
18 Years
80 Years
ALL
No
Sponsors
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genae associates (CRO), Antwerp, Belgium
UNKNOWN
King's College London
OTHER
Deutsches Herzzentrum Muenchen
OTHER
Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Karl-Heinz Kuck, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Asklepios St. Georg, Hamburg
Locations
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Clinique Pasteur Toulouse
Toulouse, Cedex 3, France
Herz-Zentrum Bad Krozingen
Bad Krozingen, , Germany
Cardioangiologisches Centrum Bethanien CCB
Frankfurt am Main, , Germany
Asklepios St. Georg
Hamburg, , Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck
Lübeck, , Germany
Countries
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Other Identifiers
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MDT17037
Identifier Type: -
Identifier Source: org_study_id