From the Emergency Department Directly to Ablation of Atrial Fibrillation Study (EMERGE Cryo)
Primary Purpose
Atrial Fibrillation (AF)
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Ablation of atrial fibrillation (AF)
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation (AF) focused on measuring Ablation
Eligibility Criteria
Inclusion Criteria:
- Documented, paroxysmal or persistent AF (longest AF episode < 6-month duration). Any ECG documentation of AF (12 lead ECG, Holter ECG or mobile ECG monitoring) needs to be presented.
- Recent-onset AF (≤ 1 year prior to enrolment)
- Presenting at the emergency department or outpatient clinic within the last 2 weeks because of AF, including patients with spontaneous conversion in sinus rhythm (with prior AF documentation)
- Age ≥ 18 years
- Subject is able and willing to give informed consent
Exclusion Criteria
- Pers. AF > 6 Mon (one episode)
- LA-Diameter > 60mm
- Severe mitral stenosis or regurgitation, prior mitral valve reconstruction or replacement
- Any previous left atrial ablation
- Ongoing continuous AAD therapy with Amiodarone at baseline
- History of failed continuous AAD therapy with > 1 agent. Exceptions are Beta blocker, Verapamil or "pill in the pocket"-therapy.
- Any condition or disease, which is contraindication for AF ablation, up to the assessment of the investigator
- Any condition or disease, which is a contraindication for antiarrhythmic drug treatment, up to the assessment of the investigator
- Known intra-cardiac thrombus formation under continuous oral anticoagulation (defined as intake >4 weeks)
- Any contraindication for oral anticoagulation
- Any untreated or uncontrolled hyperthyroidism or other reversible causes for AF like alcoholism
- Pregnant or breastfeeding woman or woman of childbearing potential not on adequate birth control
- Active systemic infection
- Co-Existence of non PV-dependent atrial Tachycardia
Sites / Locations
- Asklepios Hospital St. GeorgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Group1: Cryo-AF-Ablation
Group 2: Usual care
Arm Description
Patients randomized in the Cryo-AF-Ablation group should receive the cryo AF ablation within 21 days from baseline.
Patients randomized in the usual care group should start or maintain on AAD therapy within 21 days from baseline, based on decision of the investigator according to current ESC Guidelines.
Outcomes
Primary Outcome Measures
Freedom from any atrial tachyarrhythmia
Freedom from any atrial tachyarrhythmia, including atrial fibrillation (AF), atrial flutter and atrial tachycardias (>30 s) through 3 to 12 months follow-up on ILR monitoring or any 12 lead ECG on visits, ECG Holter monitoring, or on symptom driven event monitoring
Secondary Outcome Measures
AF burden (1)
AF burden between 3 to 12 months after randomization. AF burden is defined as overall percentage of AF during the observed time
AF burden (2)
AF burden between 0 to 3, 3 to 6 and 6 to 12 months after randomization
Freedom from atrial fibrillation
Freedom from atrial fibrillation (AF) (>30 s)
Freedom from atrial tachycardia and atrial flutter
Freedom from atrial tachycardia and atrial flutter (AFl)
symptomatic versus asymptomatic atrial tachyarrhythmia
Analysis of amount of symptomatic versus asymptomatic atrial tachyarrhythmia recurrences
Re-hospitalization rate
Re-hospitalization rate due to cardiovascular disease (AF, worsening of heart failure, cardiovascular disease)
Progression of heart failure
Progression of heart failure defined as trend in LV-EF and trend in BNP
Quality of life (AFEQT and EQ-5D-5L)
Improvement of quality of life at 12 months compared to baseline (AFEQT and EQ-5D-5L Questionnaire)
Safety / Complications
Safety / Complications
Full Information
NCT ID
NCT05294445
First Posted
March 4, 2022
Last Updated
March 23, 2022
Sponsor
Asklepios proresearch
Collaborators
Atrial Fibrillation Network, Medtronic Bakken Research
1. Study Identification
Unique Protocol Identification Number
NCT05294445
Brief Title
From the Emergency Department Directly to Ablation of Atrial Fibrillation Study
Acronym
EMERGE Cryo
Official Title
From the Emergency Department Directly to Ablation of Atrial Fibrillation - Study - The "EMERGE Cryo Study"
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
December 14, 2026 (Anticipated)
Study Completion Date
December 14, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asklepios proresearch
Collaborators
Atrial Fibrillation Network, Medtronic Bakken Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is a prospective, two-arm, randomized, open-label, blinded endpoint, multi-center study to investigate the impact of first line ablation in patients presenting at the emergency room with recent-onset paroxysmal or persistent atrial fibrillation.
Detailed Description
As stated in the current guidelines, the prevalence of AF tripled over the last 30 years and further progress is expected. AF is associated with increased mortality and morbidity. Approximately 70% of the patients who are hospitalized for AF are admitted through the emergency department. The steady increase of AF-related visits at the emergency departments therefore lead to a high number of hospitalizations. The direct costs of AF already amount to approximately 1% of total healthcare spending, driven by AF-related complications (e.g. stroke) and treatment costs (e.g. hospitalizations). These costs will increase dramatically unless AF is prevented and treated in a timely and effective manner.
Catheter ablation therapy has been proven to be safe and effective for the treatment of paroxysmal and persistent AF and is now standard in AF therapy. Several trials have shown that catheter ablation of AF is superior to antiarrhythmic drug therapy. As evidenced by the FIRE & ICE trial, cryoballoon ablation is non-inferior to the former goldstandard of radiofrequency current (RFC) energy. Importantly, it has been reported that cryoballoon ablation was associated with a reduction in resource use and costs as compared to RFC ablation of AF. These cost savings persisted over multiple healthcare systems.
However, data on the optimal timing of AF ablation is scarce. While there is evidence that catheter ablation is highly efficient in delaying progression from paroxysmal to persistent AF, there are only few trials evaluating a strategy of early treatment of AF, regarding the patients' medical history (CRYO-FIRST, EARLY-AF). Another trial investigated the utilization of a multidisciplinary AF treatment pathway in patients presenting to the emergency department, which resulted in reduction of admission rate and hospital stays but did not include catheter ablation of AF. However, there is no scientific evidence on a strategy of early treatment of atrial fibrillation comparing anti-arrhythmic drug therapy to catheter ablation in the large number of patients presenting to the emergency departments.
A well-known limitation of many trials investigating catheter ablation of AF, can be found during the trials follow up after ablation, as detection of AF recurrences can be challenging. The sensitivity of detecting asymptomatic episodes with intermittent 24-hours ECG-monitoring is low. The Heart Rhythm Society and the European Heart Rhythm Society encourage continuous arrhythmia monitoring due to the greater sensitivity in detecting symptomatic and asymptomatic AF recurrences but also when assessing the overall AF burden. Additionally, in an era of digital revolution, the AFNET incorporated the use of wearables, smartphones, hand held-devices and health-related apps to new approaches of AF management.
To evaluate the efficacy and safety of an early rhythm control treatment of AF by catheter ablation with the cryoballoon with particular respect to arrhythmia recurrence, rehospitalisation, heart failure and health care costs in patients presenting to the emergency department due to AF, a prospective randomized study is necessary.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation (AF)
Keywords
Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, two-arm, randomized, open-label, blinded endpoint, multi-center study
Masking
Outcomes Assessor
Masking Description
Additionally to ILR interrogation on each site, the ILR data will be reviewed by blinded core lab investigators. All observed primary endpoints and outcome parameters will be presented to ERC.
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group1: Cryo-AF-Ablation
Arm Type
Active Comparator
Arm Description
Patients randomized in the Cryo-AF-Ablation group should receive the cryo AF ablation within 21 days from baseline.
Arm Title
Group 2: Usual care
Arm Type
No Intervention
Arm Description
Patients randomized in the usual care group should start or maintain on AAD therapy within 21 days from baseline, based on decision of the investigator according to current ESC Guidelines.
Intervention Type
Procedure
Intervention Name(s)
Ablation of atrial fibrillation (AF)
Intervention Description
Cryo-AF-ablation of pulmonary vein (pulmonary vein isolation = PVI)
Primary Outcome Measure Information:
Title
Freedom from any atrial tachyarrhythmia
Description
Freedom from any atrial tachyarrhythmia, including atrial fibrillation (AF), atrial flutter and atrial tachycardias (>30 s) through 3 to 12 months follow-up on ILR monitoring or any 12 lead ECG on visits, ECG Holter monitoring, or on symptom driven event monitoring
Time Frame
within 3 to 12 months follow-up
Secondary Outcome Measure Information:
Title
AF burden (1)
Description
AF burden between 3 to 12 months after randomization. AF burden is defined as overall percentage of AF during the observed time
Time Frame
within 3 to 12 months follow up
Title
AF burden (2)
Description
AF burden between 0 to 3, 3 to 6 and 6 to 12 months after randomization
Time Frame
within 0 to 12 months follow up
Title
Freedom from atrial fibrillation
Description
Freedom from atrial fibrillation (AF) (>30 s)
Time Frame
within 3 to 12 months follow up
Title
Freedom from atrial tachycardia and atrial flutter
Description
Freedom from atrial tachycardia and atrial flutter (AFl)
Time Frame
within 3 to 12 months follow up
Title
symptomatic versus asymptomatic atrial tachyarrhythmia
Description
Analysis of amount of symptomatic versus asymptomatic atrial tachyarrhythmia recurrences
Time Frame
within 3 to 12 months follow up
Title
Re-hospitalization rate
Description
Re-hospitalization rate due to cardiovascular disease (AF, worsening of heart failure, cardiovascular disease)
Time Frame
up to 12 months follow up
Title
Progression of heart failure
Description
Progression of heart failure defined as trend in LV-EF and trend in BNP
Time Frame
up to 12 months follow up
Title
Quality of life (AFEQT and EQ-5D-5L)
Description
Improvement of quality of life at 12 months compared to baseline (AFEQT and EQ-5D-5L Questionnaire)
Time Frame
within 0 to 12 months follow up
Title
Safety / Complications
Description
Safety / Complications
Time Frame
within 0 to 12 months follow up
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:
Documented, paroxysmal or persistent AF (longest AF episode < 6-month duration). Any ECG documentation of AF (12 lead ECG, Holter ECG or mobile ECG monitoring) needs to be presented.
Recent-onset AF (≤ 1 year prior to enrolment)
Presenting at the emergency department or outpatient clinic within the last 2 weeks because of AF, including patients with spontaneous conversion in sinus rhythm (with prior AF documentation)
Age ≥ 18 years
Subject is able and willing to give informed consent
Exclusion Criteria
Pers. AF > 6 Mon (one episode)
LA-Diameter > 60mm
Severe mitral stenosis or regurgitation, prior mitral valve reconstruction or replacement
Any previous left atrial ablation
Ongoing continuous AAD therapy with Amiodarone at baseline
History of failed continuous AAD therapy with > 1 agent. Exceptions are Beta blocker, Verapamil or "pill in the pocket"-therapy.
Any condition or disease, which is contraindication for AF ablation, up to the assessment of the investigator
Any condition or disease, which is a contraindication for antiarrhythmic drug treatment, up to the assessment of the investigator
Known intra-cardiac thrombus formation under continuous oral anticoagulation (defined as intake >4 weeks)
Any contraindication for oral anticoagulation
Any untreated or uncontrolled hyperthyroidism or other reversible causes for AF like alcoholism
Pregnant or breastfeeding woman or woman of childbearing potential not on adequate birth control
Active systemic infection
Co-Existence of non PV-dependent atrial Tachycardia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nele Gessler, MD, PhD
Phone
+49-40-181885-3069
Email
n.gessler@asklepios.com
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Gunawardene, MD, PhD
Phone
+49-40-181885-5412
Email
m.gunawardene@asklepios.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Willems, MD, PhD
Organizational Affiliation
Asklepios Hospital St. Georg, Hamburg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asklepios Hospital St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Willems, MD, PhD
Email
s.willems@asklepios.com
12. IPD Sharing Statement
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From the Emergency Department Directly to Ablation of Atrial Fibrillation Study
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