Atrial FibrillationPAVANENCT01276093
Pulmonary Vein Ablation Versus Amiodarone in the Elderly
A study testing PVI ablation and Amiodarone in people with Atrial Fibrillation, run by Abbott Medical Devices at 6 sites in Netherlands.
Trial summary
The purpose of the study is to demonstrate that in patients of 70 years or older with symptomatic paroxysmal atrial fibrillation (AF) pulmonary vein isolation (PVI) using RF ablation therapy is superior to medical treatment with amiodarone to prevent recurrence of AF. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- PVI ablation and Amiodarone
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 6 sitesNetherlands
- Study dates
- Jul 2011to Mar 2016
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years at moment of screening, able to sign informed consent.
- Documented paroxysmal AF in association with complaints in the last year, with at least 2 episodes of complaints attributed to AF in the previous 2 months.
- Paroxysmal AF documented with at least one ECG with sinus rhythm not after cardioversion in the last year.
- No prior use of amiodarone in the last 6 months and no usage longer than 4 weeks in total.
Who cannot join
- EF < 35 % or description of "poor left ventricular function" on echocardiogram. Measurement should not be older than 6 months at moment of screening.
- Aortic, mitral, pulmonary or tricuspid valve regurgitation or stenosis, if graded severe (grade >3)
- Acute illness: unstable angina, infectious disease.
- Primary structural or electrical heart disease: dilated cardiomyopathy, hypertrophic cardiomyopathy, Brugada syndrome, long QT syndrome.
- Reversible causes (thyroid dysfunction, uncontrolled hypertension, ischemia).
- Previous ablation.
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- Contraindications for amiodarone; liver dysfunction (serum alanine aminotransferase >2.5 times upper limit); thyroid dysfunction; chronic lung disease; baseline QTc >460 ms. sinus node dysfunction (pause more than 3 seconds in sinus rhythm); second or third degree AV-block.
- Contraindications for anti-coagulation: prior life threatening hemorrhage under use of Vitamin K antagonists.
- Any myocardial infarction or PCI in previous 6 months.
- CABG in previous 6 months.
- Renal dysfunction: creatinine clearance <45 ml/min
- Severe co-morbidity. Life expectancy less than 1 year.
- Thrombus in left atrium
- Untreatable allergy to contrast media
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Onze Lieve Vrouwen Gasthuis
Amsterdam, 1091 AC
Catharina Ziekenhuis
Eindhoven, 5623 EJ
Medisch Spectrum Twente
Enschede, 7513 ER
Elkerliek Hospital
Helmond, North Brabant
Haga Hospital
The Hague, South Holland, 2545 CH
Maxima Medical Center
Veldhoven, North Brabant, 5504DB
About this study
The purpose of the study is to demonstrate that in patients of 70 years or older with symptomatic paroxysmal atrial fibrillation (AF) pulmonary vein isolation (PVI) using RF ablation therapy is superior to medical treatment with amiodarone to prevent recurrence of AF.
Read the detailed description
Atrial fibrillation (AF) is the most common arrhythmia. The prevalence of AF is highly age dependent as 70% of AF patients is between 65 and 85 years old. With increasing life expectancy, AF prevalence will increase 2,5 times during the next 50 years and constitute an even more important health concern. In younger patients Pulmonary vein ablation is an accepted procedure with superior efficacy compared to medical treatment. In this study the safety and efficacy of PVI in patients over 70 years old will be evaluated.
- Conditions
- Atrial Fibrillation
- Being tested
- PVI ablation, Amiodarone
- Keywords
- Atrial fibrillation, PVI ablation, Elderly patients, Efficacy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVI ablationProcedure or surgery
Also called Pulmonary Vein Isolation
Pulmonary Vein Ablation using RF.
AmiodaroneDrug
Amiodarone tablets
| Study group | Role | What they receive |
|---|---|---|
| PVI ablation | Experimental | Pulmonary Vein Ablation Receives: Procedure: PVI ablation |
| Amiodarone medical treatment | Active comparator | Amiodarone medical treatment Receives: Drug: Amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of episodes of AF, atypical atrial flutter or left sided atrial tachycardia
Measured: Until 1 year after post treatment blanking period
Secondary outcomes (1)
Composite end point of hospitalization, stroke, major bleeding and death
Measured: Until last patient has been followed for 15 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2015
- Study completionMar 2016 (estimated)
Why it stopped: DSMB recommendation; enrollment too slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lukas Dekker, Dr, Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276093
- Sponsor's protocol ID
- AF-10-023-ND-AB
- Acronym
- PAVANE
- Status last verified
- Dec 2015
- First submitted
- 11 Jan 2011
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vein Ablation Versus Amiodarone in the Elderly
- ClinicalTrials.gov ID
- NCT01276093
- Acronym / sponsor ID
- PAVANE / AF-10-023-ND-AB
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, PVI ablation, Elderly patients, Efficacy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB recommendation; enrollment too slow
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (estimated)
- First posted
- 13 Jan 2011 (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.
The purpose of the study is to demonstrate that in patients of 70 years or older with symptomatic paroxysmal atrial fibrillation (AF) pulmonary vein isolation (PVI) using RF ablation therapy is superior to medical treatment with amiodarone to prevent recurrence of AF.
Detailed description
Atrial fibrillation (AF) is the most common arrhythmia. The prevalence of AF is highly age dependent as 70% of AF patients is between 65 and 85 years old. With increasing life expectancy, AF prevalence will increase 2,5 times during the next 50 years and constitute an even more important health concern. In younger patients Pulmonary vein ablation is an accepted procedure with superior efficacy compared to medical treatment. In this study the safety and efficacy of PVI in patients over 70 years old will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI ablation | Experimental | Procedure: PVI ablationPulmonary Vein Ablation |
| Amiodarone medical treatment | Active comparator | Drug: AmiodaroneAmiodarone medical treatment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥ 65 years at moment of screening, able to sign informed consent.
- Documented paroxysmal AF in association with complaints in the last year, with at least 2 episodes of complaints attributed to AF in the previous 2 months.
- Paroxysmal AF documented with at least one ECG with sinus rhythm not after cardioversion in the last year.
- No prior use of amiodarone in the last 6 months and no usage longer than 4 weeks in total.
Key exclusion criteria (14 listed)
- EF < 35 % or description of "poor left ventricular function" on echocardiogram. Measurement should not be older than 6 months at moment of screening.
- Aortic, mitral, pulmonary or tricuspid valve regurgitation or stenosis, if graded severe (grade >3)
- Acute illness: unstable angina, infectious disease.
- Primary structural or electrical heart disease: dilated cardiomyopathy, hypertrophic cardiomyopathy, Brugada syndrome, long QT syndrome.
- Reversible causes (thyroid dysfunction, uncontrolled hypertension, ischemia).
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 |
|---|---|---|
| PVI ablationAlso: Pulmonary Vein IsolationPulmonary Vein Ablation using RF. | Procedure or surgery | PVI ablation |
| AmiodaroneAmiodarone tablets | Drug | Amiodarone medical treatment |
Primary outcome
Recurrence of episodes of AF, atypical atrial flutter or left sided atrial tachycardia
Time frame: Until 1 year after post treatment blanking period
1 secondary outcome
Composite end point of hospitalization, stroke, major bleeding and death
Time frame: Until last patient has been followed for 15 months after inclusion
Results and safety
The study was stopped early (reason given: DSMB recommendation; enrollment too slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
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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.
Lukas Dekker, Dr principal investigator
Catharina Ziekenhuis Eindhoven
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVI ablation and Amiodarone in people with Atrial Fibrillation, run by Abbott Medical Devices at 6 sites in Netherlands.
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 14 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: stopped early, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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?
The study was stopped early (reason given: DSMB recommendation; enrollment too slow). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of episodes of AF, atypical atrial flutter or left sided atrial tachycardia (time frame: Until 1 year after post treatment blanking period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2015.