Atrial FibrillationCRYO-LPAFNCT02294929
Cryoballoon Ablation in Patients With Longstanding Persistent Atrial Fibrillation
A study testing Atrial fibrillation ablation in people with Atrial Fibrillation, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
Prospective and explorative clinical study. The objective is to assess the clinical efficacy of pulmonary vein isolation using the Arctic Front Advance cryoballoon in patients with longstanding persistent atrial fibrillation (AF) at one year follow up. 44 subjects will be enrolled. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Atrial fibrillation ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2013to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with longstanding persistent AF, with continuous AF of greater than one year, as verified by ECG or telemetry strip at least one year ago, and at inclusion but with no documentation of sinus rhythm in between.
- Atrial fibrillation should be confirmed on at least 2 consecutive ECG supporting the presence of AF for at least one year.
- Patients with symptoms corresponding to at least EHRA score 2.
- Patients, who have not previously undergone an AF ablation procedure, should have failed at least a betablocker or class I or III antiarrhythmic drug.
Who cannot join
- Sinus rhythm cannot be maintained for at least 1 minute after an electrical cardioversion.
- Congestive heart failure with NYHA class 3 or more.
- LVEF < 35% which is not secondary to AF with inadequate rate control, according to the judgement of the investigator.
- LA diameter ≥ 55 mm by echocardiography.
- Prior AF ablation procedure of any kind.
- AF secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and uncontrolled thyroid disease as well as AF triggered by other uniform supraventricular tachycardia.
Show all 16Show fewer
- Contraindication to treatment with Warfarin or other anticoagulants.
- Significant valvular disease or planned cardiac intervention.
- Hypertrophic cardiomyopathy.
- Recent cardiac disease states within the last 6 months; unstable angina, acute myocardial infarction, revascularisation procedures, valve disease
- Implantable cardioverter-defibrillator (ICD), biventricular pacing device, or Dual chamber- or single chamber pacemaker patients who are dependent on ventricular pacing
- Patients with intra-atrial thrombus, tumor, pulmonary embolism or another abnormality in whom transseptal catheterization or appropriate vascular access is precluded.
- Renal failure requiring dialysis or abnormalities of liver function tests.
- Participant in investigational clinical or device trial.
- Unwilling or unable to give informed consent or inaccessible for follow-up and psychological problem that might limit compliance.
- Active abuse of alcohol or other substance which may be causative of AF and/or might affect compliance.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Carina Blomström Lundqvist
Uppsala, 75185
Carina M Blomström Lundqvist, Professor, +46186113113, carina.blomstrom.lundqvist@akademiska.se
David Mörtsell, PHD student
About this study
Official title: Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Longstanding Persistent Atrial Fibrillation (the CRYO-LPAF Study)
Prospective and explorative clinical study. The objective is to assess the clinical efficacy of pulmonary vein isolation using the Arctic Front Advance cryoballoon in patients with longstanding persistent atrial fibrillation (AF) at one year follow up.
44 subjects will be enrolled. Patients with longstanding persistent AF, with continuous AF duration longer than one year, who have not previously undergone an AF ablation procedure, and have symptoms related to AF corresponding to at least European Heart Rhythm Association (EHRA) score 2, will be studied. Patients should have failed at least one betablocker or class I or III antiarrhythmic drug.
Read more
Excluded are those with congestive heart failure with New York Heart Association (NYHA) class 3 or more, left ventricular ejection fraction < 40%, left atrial diameter ≥ 60 mm, significant valvular disease or planned cardiac intervention within next 12 months, and conventional contraindications for AF ablation procedures.
Patients will be screened with echocardiography and response to electrical cardioversion. Following conversion to sinus rhythm, amiodarone will be initiated to maintain sinus rhythm. Pulmonary vein isolation will be performed using the Arctic Front Advance cryoballoon ablation catheter. Pulmonary vein conduction block will be assessed by a circular mapping catheter.
All patients will be subject to electroanatomical voltage mapping during sinus rhythm for demonstration of extent of atrial myocardial lesions after ablation.
Patients will be followed every third month up to one year after the ablation procedure. Arrhythmia monitoring during follow up will be performed by 7 day Holter monitoring at 6, 9 and 12 months follow up, including a 12 lead ECG. 12 months follow up for symptoms, EHRA score, and quality of life. Patients with symptomatic recurrence requiring a redo ablation procedure will be re-studied after 8-12 months while asymptomatic patients will be studied at 12 months follow up.
Primary end-Point is Clinical success based on symptoms and presence of AF. Secondary end-Points include freedom from AF without antiarrhythmic drugs at 6 and 12 months according to 7 day Holter and ECG, Rhythm, AF burden, AF profile, Quality of Life, Symptoms, Adverse Events, atrial size and function, Biomarkers, extent of scar tissue, predictive factors of freedom from AF, complications, hospitalization and Health economics.
Read the detailed description
This is a prospective and explorative clinical study performed at one centre. Objective: The objective of this study is to assess the clinical efficacy of pulmonary vein isolation using the Arctic Front Advance cryoballoon in patients with longstanding persistent atrial fibrillation (AF) at one year follow up.
44 subjects will be enrolled. Clinical sites: Arrhythmia centre in Uppsala University Hospital, Uppsala Sweden.
Subject population: Patients with longstanding persistent AF, with continuous AF of longer duration than one year, who have not previously undergone an AF ablation procedure, and who have symptoms related to AF corresponding to at least EHRA score 2, will be studied. Atrial fibrillation should be confirmed on at least 2 consecutive ECG recordings during the past one year supporting the presence of AF for at least one year. Patients should have failed at least a betablocker or class I or III antiarrhythmic drug.
In order to exclude permanent AF patients, an electrical cardioversion with conversion to sinus rhythm maintained for at least one hour, is required.
Excluded patients are those with congestive heart failure with New York Heart Association (NYHA) class 3 or more, left ventricular ejection fraction (LVEF) < 40%, left atrial diameter (LA) ≥ 60 mm, significant valvular disease or planned cardiac intervention within the next 12 months, and conventional medical contraindications for AF ablation procedures.
Pulmonary vein isolation: Pulmonary vein isolation (PVI) will be performed using the Arctic Front Advance cryoballoon ablation catheter. Acute procedural success is defined as electrical isolation of all pulmonary veins assessed by entrance and exit block, including 20 minutes waiting time and the use of the provocative agent adenosine to screen for early recurrence of PV conduction.
Design of the study: Patients will be screened with echocardiography and response to electrical cardioversion. Following conversion to sinus rhythm, amiodarone will be initiated in order to maintain sinus rhythm.
After cryoballoon ablation of all pulmonary veins, PV conduction block will be assessed by a circular mapping catheter, including waiting time and provocative agents. All patients will be subject to electro anatomical voltage mapping during sinus rhythm for demonstration of the extent of atrial myocardial lesions after ablation. Biomarkers including nTproBNP and troponin I, reflecting myocardial strain and destruction, will be collected at baseline and at different time points after the procedure.
Patients will be followed every third month up to one year after the ablation procedure. Amiodarone will be withdrawn one month after the ablation procedure.
Arrhythmia monitoring during follow up will be performed by a 7 day Holter monitoring every third month at 6, 9 and 12 months follow up, including a 12 lead ECG.
A transthoracic echocardiography will be repeated at 12 months follow up to assess LA volume and contractility. Symptoms, EHRA score, and quality of life (QoL) will be evaluated. Predictive variables for successful outcome/AF recurrence will be analysed.
All patients will be reinvestigated for assessment of PV re-conduction using a circular mapping catheter, irrespective of symptoms. Patients with symptomatic recurrence requiring a redo ablation procedure will be re-studied after 8-12 months while asymptomatic patients will be studied at 12 months follow up.
Primary end-point:
Clinical success defined as
- Freedom from AF related symptoms, off or on previously ineffective antiarrhythmic drugs irrespective of the presence of asymptomatic AF on Holter. AF may be either absent or paroxysmal in nature, or
- Presence of AF related symptoms, off or on previously ineffective antiarrhythmic drugs, but with significant symptomatic improvement to the extent that a redo procedure or a novel previously not tested antiarrhythmic drug is not desired as declared by the patient on a symptom questionnaire. Atrial fibrillation may be either absent or paroxysmal as recorded on Holter or ECG tracings after 1 or 2 procedures at 12 months.
Secondary end-points:
- Complete freedom from AF without antiarrhythmic drugs at 6 and 12 months after 1-2 ablation procedures according to 7 day Holter and ECG.
- Rhythm (% of subjects in sinus rhythm, paroxysmal AF and persistent AF) at 12 months.
- AF burden on 7 day Holter at 12 months.
- AF profile
- Assess whether PVI is crucial for elimination of AF in patients with longstanding persistent AF. Correlation between freedom from AF/recurrence and PV isolation/re-conduction at repeat electrophysiological study.
- Systemic blood pressure.
- Quality of Life determined by standardized questionnaires (SF 36, with all domains and time-points and EQ 5D).
- Symptoms (Symptoms Severity Questionnaire and EHRA Symptom Classification).
- Incidence, intensity and relationship of Adverse Events.
- Left and right atrial size and function (sinus rhythm) (echocardiography corrected for Body Surface area, dPdT) prior to and after ablation at 12 months.
- Biomarkers including nTproBNP and troponin I, reflecting myocardial strain and destruction, will be collected at baseline and at different time points after the procedure. A biomarker reflecting fibrosis and brain damage will be analysed.
- Extent of scar tissue as indicated by LA voltage mapping at baseline and extent of electrical silence around PV postablation.
- A subgroup analysis will determine whether sinus rhythm obtained by AF ablation is superior AF with regard to all secondary endpoints including QoL, Symptoms, cardiovascular hospitalizations, safety, biomarkers, left atrial size and function, at 12 months.
- Prediction of freedom from AF by risk variables including LA volume, LA contractility (strain rate), LA intracardiac pressures and dpdt, Atrial amplitude analysis during AF prior ablation, extent of scar tissue as assessed by a voltage mapping at baseline during sinus rhythm, biomarkers, and demographic variables (AF duration, hypertension, ischemic heart disease, diabetes and CHADS2VASscore).
- Catheter related complications.
- Cardiovascular hospitalization
- Health economics
- Conditions
- Atrial Fibrillation
- Being tested
- Atrial fibrillation ablation
- Keywords
- catheter ablation, cryoballoon
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial fibrillation ablationProcedure or surgery
Also called Medtronic Arctic Front™ Advance Cardiac CryoAblation System, The Arctic Front™ Advance Cardiac CryoAblation Catheter, The FlexCath™ Steerable Sheath, CryoCath Cryoablation Console
Atrial fibrillation ablation using the Arctic Front™ Advance Cardiac CryoAblation Catheter in two balloon sizes (23mm and 28mm) for pulmonary vein isolation
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation ablation | Other | Cryoballoon ablation for pulmonary vein isolation Receives: Procedure: Atrial fibrillation ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
Clinical success defined as:
- Freedom from AF related symptoms, off or on previously ineffective antiarrhythmic drugs irrespective of the presence of asymptomatic AF on Holter provided AF is absent or paroxysmal in nature AF, or
- Presence of AF related symptoms, off or on previously ineffective antiarrhythmic drugs, but significant symptomatic improvement to the extent that a redo procedure or a novel previously not tested antiarrhythmic drug is not desired as declared by the patient on a symptom questionnaire. Atrial fibrillation may be either absent or paroxysmal as recorded on Holter or ECG tracings after 1 or 2 procedures at 12 months.
Measured: 12 months
Secondary outcomes (12)
Complete freedom from AF
Complete freedom from AF without antiarrhythmic drugs after 1-2 ablation procedures according to 7 day Holter and ECG
Measured: 6, 12 months
Rhythm assessed by % of subjects in sinus rhythm, paroxysmal AF and persistent AF
% of subjects in sinus rhythm, paroxysmal AF and persistent AF
Measured: 12 months
Atrial Fibrillation burden
AF burden on 7 day Holter defined as time spent in AF as recorded by Holter monitoring
Measured: 12 months
Role of Pulmonary vein isolation for elimination of atrial fibrillation
Correlation between AF recurrence and re-conduction at repeat EP study.
Measured: 12 months
Quality of life
Quality of Life (Short form (SF)-36 all domains and time-points.
Measured: 12 months
Symptoms Severity Questionnaire and EHRA Symptom Classification
Symptom Severity Questionnaire and EHRA Symptom Classification
Measured: 12 months
Biomarkers
Biomarkers reflecting myocardial strain and destruction (Troponin I, Nt-proBNP), collected at baseline and at different time points after the procedure. A biomarker reflecting fibrosis (TGF-β1 and aminoterminal peptide of procollagen type III) and brain damage (S100β, a dimeric calcium-binding protein) will be analysed.
Measured: Baseline, 6 hours, 24 hours, 12 months
Scar tissue
Extent of scar tissue as indicated by left atrial voltage mapping at baseline and extent of electrical silence around pulmonary vein postablation, and measures of intra-atrial conduction times in right and left Atria.
Measured: 12 months
Prediction of freedom from AF
Prediction of freedom from AF by risk variables including left atrial (LA) volume, LA contractility, intracardiac pressures and LA dPdT, Atrial amplitude analysis during AF prior ablation, extent of scar tissue as assessed by a voltage mapping, biomarkers and demographic variables variables (AF duration, hypertension, ischemic heart disease, diabetes and CHADS2VASscore)
Measured: 12 months
Health economics
Quality of Life assessed by EuroQual (EQ) 5D and all Cardiovascular hospitalizations, interventions and events.
Measured: 12 months
Catheter related complications
Catheter related complications at and after ablation
Measured: 12 months
Left and right atrial size and function
Left and right atrial size and function (sinus rhythm) (echocardiography corrected for body Surface area)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Heart Lung Foundation, Medtronic
- Responsible party
- Principal investigator, Carina Blomstrom Lundqvist, Uppsala University Hospital
- Investigators
- Carina M Blomström Lundqvist, Professor, Principal investigator, Department of Cardiology, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294929
- Sponsor's protocol ID
- CRYO-LPAF
- Acronym
- CRYO-LPAF
- Status last verified
- May 2017
- First submitted
- 12 Nov 2014
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Aytemir K, Gurses KM, Yalcin MU, Kocyigit D, Dural M, Evranos B, Yorgun H, Ates AH, Sahiner ML, Kaya EB, Oto MA. Safety and efficacy outcomes in patients undergoing pulmonary vein isolation with second-generation cryoballoondagger. Europace. 2015 Mar;17(3):379-87. doi: 10.1093/europace/euu273. Epub 2014 Nov 5.
PubMed 25376699
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Longstanding Persistent Atrial Fibrillation (the CRYO-LPAF Study)
- ClinicalTrials.gov ID
- NCT02294929
- Acronym / sponsor ID
- CRYO-LPAF / CRYO-LPAF
- Conditions
- Atrial Fibrillation
- Keywords
- catheter ablation, cryoballoon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Swedish Heart Lung Foundation, Medtronic
- Study start
- Sep 2013 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective and explorative clinical study. The objective is to assess the clinical efficacy of pulmonary vein isolation using the Arctic Front Advance cryoballoon in patients with longstanding persistent atrial fibrillation (AF) at one year follow up.
44 subjects will be enrolled. Patients with longstanding persistent AF, with continuous AF duration longer than one year, who have not previously undergone an AF ablation procedure, and have symptoms related to AF corresponding to at least European Heart Rhythm Association (EHRA) score 2, will be studied. Patients should have failed at least one betablocker or class I or III antiarrhythmic drug.
Excluded are those with congestive heart failure with New York Heart Association (NYHA) class 3 or more, left ventricular ejection fraction < 40%, left atrial diameter ≥ 60 mm, significant valvular disease or planned cardiac intervention within next 12 months, and conventional contraindications for AF ablation procedures.
Patients will be screened with echocardiography and response to electrical cardioversion. Following conversion to sinus rhythm, amiodarone will be initiated to maintain sinus rhythm. Pulmonary vein isolation will be performed using the Arctic Front Advance cryoballoon ablation catheter. Pulmonary vein conduction block will be assessed by a circular mapping catheter.
All patients will be subject to electroanatomical voltage mapping during sinus rhythm for demonstration of extent of atrial myocardial lesions after ablation.
Patients will be followed every third month up to one year after the ablation procedure. Arrhythmia monitoring during follow up will be performed by 7 day Holter monitoring at 6, 9 and 12 months follow up, including a 12 lead ECG. 12 months follow up for symptoms, EHRA score, and quality of life. Patients with symptomatic recurrence requiring a redo ablation procedure will be re-studied after 8-12 months while asymptomatic patients will be studied at 12 months follow up.
Primary end-Point is Clinical success based on symptoms and presence of AF. Secondary end-Points include freedom from AF without antiarrhythmic drugs at 6 and 12 months according to 7 day Holter and ECG, Rhythm, AF burden, AF profile, Quality of Life, Symptoms, Adverse Events, atrial size and function, Biomarkers, extent of scar tissue, predictive factors of freedom from AF, complications, hospitalization and Health economics.
Detailed description
This is a prospective and explorative clinical study performed at one centre. Objective: The objective of this study is to assess the clinical efficacy of pulmonary vein isolation using the Arctic Front Advance cryoballoon in patients with longstanding persistent atrial fibrillation (AF) at one year follow up.
44 subjects will be enrolled. Clinical sites: Arrhythmia centre in Uppsala University Hospital, Uppsala Sweden.
Subject population: Patients with longstanding persistent AF, with continuous AF of longer duration than one year, who have not previously undergone an AF ablation procedure, and who have symptoms related to AF corresponding to at least EHRA score 2, will be studied. Atrial fibrillation should be confirmed on at least 2 consecutive ECG recordings during the past one year supporting the presence of AF for at least one year. Patients should have failed at least a betablocker or class I or III antiarrhythmic drug.
In order to exclude permanent AF patients, an electrical cardioversion with conversion to sinus rhythm maintained for at least one hour, is required.
Excluded patients are those with congestive heart failure with New York Heart Association (NYHA) class 3 or more, left ventricular ejection fraction (LVEF) < 40%, left atrial diameter (LA) ≥ 60 mm, significant valvular disease or planned cardiac intervention within the next 12 months, and conventional medical contraindications for AF ablation procedures.
Pulmonary vein isolation: Pulmonary vein isolation (PVI) will be performed using the Arctic Front Advance cryoballoon ablation catheter. Acute procedural success is defined as electrical isolation of all pulmonary veins assessed by entrance and exit block, including 20 minutes waiting time and the use of the provocative agent adenosine to screen for early recurrence of PV conduction.
Design of the study: Patients will be screened with echocardiography and response to electrical cardioversion. Following conversion to sinus rhythm, amiodarone will be initiated in order to maintain sinus rhythm.
After cryoballoon ablation of all pulmonary veins, PV conduction block will be assessed by a circular mapping catheter, including waiting time and provocative agents. All patients will be subject to electro anatomical voltage mapping during sinus rhythm for demonstration of the extent of atrial myocardial lesions after ablation. Biomarkers including nTproBNP and troponin I, reflecting myocardial strain and destruction, will be collected at baseline and at different time points after the procedure.
Patients will be followed every third month up to one year after the ablation procedure. Amiodarone will be withdrawn one month after the ablation procedure.
Arrhythmia monitoring during follow up will be performed by a 7 day Holter monitoring every third month at 6, 9 and 12 months follow up, including a 12 lead ECG.
A transthoracic echocardiography will be repeated at 12 months follow up to assess LA volume and contractility. Symptoms, EHRA score, and quality of life (QoL) will be evaluated. Predictive variables for successful outcome/AF recurrence will be analysed.
All patients will be reinvestigated for assessment of PV re-conduction using a circular mapping catheter, irrespective of symptoms. Patients with symptomatic recurrence requiring a redo ablation procedure will be re-studied after 8-12 months while asymptomatic patients will be studied at 12 months follow up.
Primary end-point:
Clinical success defined as
- Freedom from AF related symptoms, off or on previously ineffective antiarrhythmic drugs irrespective of the presence of asymptomatic AF on Holter. AF may be either absent or paroxysmal in nature, or
- Presence of AF related symptoms, off or on previously ineffective antiarrhythmic drugs, but with significant symptomatic improvement to the extent that a redo procedure or a novel previously not tested antiarrhythmic drug is not desired as declared by the patient on a symptom questionnaire. Atrial fibrillation may be either absent or paroxysmal as recorded on Holter or ECG tracings after 1 or 2 procedures at 12 months.
Secondary end-points:
- Complete freedom from AF without antiarrhythmic drugs at 6 and 12 months after 1-2 ablation procedures according to 7 day Holter and ECG.
- Rhythm (% of subjects in sinus rhythm, paroxysmal AF and persistent AF) at 12 months.
- AF burden on 7 day Holter at 12 months.
- AF profile
- Assess whether PVI is crucial for elimination of AF in patients with longstanding persistent AF. Correlation between freedom from AF/recurrence and PV isolation/re-conduction at repeat electrophysiological study.
- Systemic blood pressure.
- Quality of Life determined by standardized questionnaires (SF 36, with all domains and time-points and EQ 5D).
- Symptoms (Symptoms Severity Questionnaire and EHRA Symptom Classification).
- Incidence, intensity and relationship of Adverse Events.
- Left and right atrial size and function (sinus rhythm) (echocardiography corrected for Body Surface area, dPdT) prior to and after ablation at 12 months.
- Biomarkers including nTproBNP and troponin I, reflecting myocardial strain and destruction, will be collected at baseline and at different time points after the procedure. A biomarker reflecting fibrosis and brain damage will be analysed.
- Extent of scar tissue as indicated by LA voltage mapping at baseline and extent of electrical silence around PV postablation.
- A subgroup analysis will determine whether sinus rhythm obtained by AF ablation is superior AF with regard to all secondary endpoints including QoL, Symptoms, cardiovascular hospitalizations, safety, biomarkers, left atrial size and function, at 12 months.
- Prediction of freedom from AF by risk variables including LA volume, LA contractility (strain rate), LA intracardiac pressures and dpdt, Atrial amplitude analysis during AF prior ablation, extent of scar tissue as assessed by a voltage mapping at baseline during sinus rhythm, biomarkers, and demographic variables (AF duration, hypertension, ischemic heart disease, diabetes and CHADS2VASscore).
- Catheter related complications.
- Cardiovascular hospitalization
- Health economics
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation ablation | Other | Procedure: Atrial fibrillation ablationCryoballoon ablation for pulmonary vein isolation |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with longstanding persistent AF, with continuous AF of greater than one year, as verified by ECG or telemetry strip at least one year ago, and at inclusion but with no documentation of sinus rhythm in between.
- Atrial fibrillation should be confirmed on at least 2 consecutive ECG supporting the presence of AF for at least one year.
- Patients with symptoms corresponding to at least EHRA score 2.
- Patients, who have not previously undergone an AF ablation procedure, should have failed at least a betablocker or class I or III antiarrhythmic drug.
Key exclusion criteria (16 listed)
- Sinus rhythm cannot be maintained for at least 1 minute after an electrical cardioversion.
- Congestive heart failure with NYHA class 3 or more.
- LVEF < 35% which is not secondary to AF with inadequate rate control, according to the judgement of the investigator.
- LA diameter ≥ 55 mm by echocardiography.
- Prior AF ablation procedure of any kind.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrial fibrillation ablationAlso: Medtronic Arctic Front™ Advance Cardiac CryoAblation System, The Arctic Front™ Advance Cardiac CryoAblation Catheter, The FlexCath™ Steerable Sheath, CryoCath Cryoablation ConsoleAtrial fibrillation ablation using the Arctic Front™ Advance Cardiac CryoAblation Catheter in two balloon sizes (23mm and 28mm) for pulmonary vein isolation | Procedure or surgery | Atrial fibrillation ablation |
Primary outcome
Clinical success
Time frame: 12 months
Clinical success defined as: * Freedom from AF related symptoms, off or on previously ineffective antiarrhythmic drugs irrespective of the presence of asymptomatic AF on Holter provided AF is absent or paroxysmal in nature AF, or * Presence of AF related symptoms, off or on previously ineffective antiarrhythmic drugs, but significant symptomatic improvement to the extent that a redo procedure or a novel previously not tested antiarrhythmic drug is not desired as declared by the patient on a symptom questionnaire. Atrial fibrillation may be either absent or paroxysmal as recorded on Holter or ECG tracings after 1 or 2 procedures at 12 months.
12 secondary outcomes
Complete freedom from AF
Time frame: 6, 12 months
Rhythm assessed by % of subjects in sinus rhythm, paroxysmal AF and persistent AF
Time frame: 12 months
Atrial Fibrillation burden
Time frame: 12 months
Role of Pulmonary vein isolation for elimination of atrial fibrillation
Time frame: 12 months
Quality of life
Time frame: 12 months
Symptoms Severity Questionnaire and EHRA Symptom Classification
Time frame: 12 months
Biomarkers
Time frame: Baseline, 6 hours, 24 hours, 12 months
Scar tissue
Time frame: 12 months
Prediction of freedom from AF
Time frame: 12 months
Health economics
Time frame: 12 months
Catheter related complications
Time frame: 12 months
Left and right atrial size and function
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Results publication: PubMed 25376699Aytemir K, Gurses KM, Yalcin MU, Kocyigit D, Dural M, Evranos B, Yorgun H, Ates AH, Sahiner ML, Kaya EB, Oto MA. Safety and efficacy outcomes in patients undergoing pulmonary vein isolation with second-generation cryoballoondagger. Europace. 2015 Mar;17(3):379-87. doi: 10.1093/europace/euu273. Epub 2014 Nov 5.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carina M Blomström Lundqvist, Professor principal investigator
Department of Cardiology, Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atrial fibrillation ablation in people with Atrial Fibrillation, run by Uppsala University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carina M Blomström Lundqvist, Professor (+46186113113, carina.blomstrom.lundqvist@akademiska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02294929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.