Atrial FibrillationPhase 4PAVAVNCT00605748
Pulmonary Vein (PV) -Isolation: Arrhythmogenic Vein(s) Versus All Veins
A Phase 4 study testing Segmental PV-Isolation of the arrhythmogenic vein(s) and Segmental PV-Isolation of all veins in people with Atrial Fibrillation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
We conduct a randomized study comparing the safety and effectiveness of two interventional ablation techniques for treatment of paroxysmal atrial fibrillation: the segmental pulmonary vein ablation approach, (1) with empiric isolation of all pulmonary veins or (2) Segmental Isolation of the arrhythmogenic pulmonary… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Segmental PV-Isolation of the arrhythmogenic vein(s) and Segmental PV-Isolation of all veins
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2007to Dec 2009
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients between 18 and 80 years old with paroxysmal atrial fibrillation
- Episodes with a maximum duration for 7 days
- at least 4 episodes / month
- at least one attempt with Class I or III anti-arrhythmic drugs and/or with ß-blockers without success
- sufficient oral anticoagulation for a minimum of four weeks previous to ablation
Who cannot join
- hyperthyroidism
- mitral regurgitation > II°
- intracardiac thrombi documented by transesophageal echocardiography
- left ventricular ejection< fraction 35%,
- history of ablation, myocardial infarction or cardiac surgery in the previous 3 months
- history of left-atrial ablation procedure
- contraindication for oral anticoagulation
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum Muenchen
Munich, 80636
Heidi L. Estner, MD, 0049 89 1218-2020, estner@dhm.mhn.de
Heidi L Estner, MD
About this study
Official title: PV-Isolation for Paroxysmal Atrial Fibrillation: Isolation of the Arrhythmogenic Vein(s) vs. Isolation of All Veins
We conduct a randomized study comparing the safety and effectiveness of two interventional ablation techniques for treatment of paroxysmal atrial fibrillation: the segmental pulmonary vein ablation approach, (1) with empiric isolation of all pulmonary veins or (2) Segmental Isolation of the arrhythmogenic pulmonary vein(s)
Read the detailed description
BACKGROUND Atrial fibrillation ablation procedures typically involve isolation of all pulmonary veins (PVs), yet the need for such an extensive ablation strategy in all patients is unclear.
OBJECTIVE:
We conduct a randomized study comparing the safety and effectiveness of two interventional ablation techniques for treatment of paroxysmal atrial fibrillation: the segmental pulmonary vein ablation approach, (1) with empiric isolation of all pulmonary veins or (2) Segmental Isolation of only the arrhythmogenic pulmonary vein(s). The single-blind interventional, randomized study will include 106 patients in each arm.
A reablation procedure, with the use of the same technique as the first ablation, will be offered to the patient in case of a symptomatic atrial fibrillation recurrence beyond the third month after the ablation procedure.
Follow-Up After discharge, patients w ill be scheduled for repeated visits in the arrhythmia clinic at 3 and 6 months after the first ablation. At each of these visits, intensive questioning for arrhythmia-related symptoms (fatigue, dizziness, and nausea) since the last follow-up visit was performed, especially for those that the patient had experienced before ablation. At every follow-up visit, 7-day Holter monitoring w ill be performed. Multislice CT or MRI of the pulmonary vein w ill be obtained before and 3 months after the ablation procedure for evaluation of the pulmonary vein anatomy and for detection of radiofrequency ablation-induced pulmonary vein stenosis .
Study End Points and Definitions The primary end point of the study will be freedom from atrial tachyarrhythmias (of > 30-second duration) including atrial fibrillation and atypical atrial flutter documented by 7-day Holter monitoring performed at the 6-month follow-up. Two secondary study end points will be chosen. The first will be freedom from arrhythmia-related symptoms during the 6-month follow-up. Because early recurrences of atrial tachyarrhythmias within the first month after ablation may be a transient phenomenon, this time interval was excluded from analysis. Second, a composite of periprocedural pericardial tamponade, thromboembolic complications, and pulmonary vein stenosis with > 50% lumen loss (main vessel or first branching) was defined as a safety end point
- Conditions
- Atrial Fibrillation
- Being tested
- Segmental PV-Isolation of the arrhythmogenic vein(s), Segmental PV-Isolation of all veins
- Keywords
- catheter ablation, atrial fibrillation, pulmonary vein
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Segmental PV-Isolation of the arrhythmogenic vein(s)Procedure or surgery
isolation of pulmonary veins for curing atrial fibrillation
Segmental PV-Isolation of all veinsProcedure or surgery
isolation of pulmonary veins for curing atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Segmental PV-Isolation of the arrhythmogenic vein(s) Receives: Procedure: Segmental PV-Isolation of the arrhythmogenic vein(s) |
| 2 | Active comparator | Segmental PV-Isolation of all veins Receives: Procedure: Segmental PV-Isolation of all veins |
What is being measured
The primary outcome is the main question the study is designed to answer.
freedom of atrial tachycardia 6 months after ablation
Measured: 6 months
Secondary outcomes (1)
freedom of symptoms due to atrial tachycardia 6 months after ablation safety
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2009 (estimated)
- Study completionDec 2009 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Investigators
- Isabel Deisenhofer, MD, Study chair, Deutsches Herzzentrum MuenchenHeidi L. Estner, MD, Principal investigator, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605748
- Sponsor's protocol ID
- GE IDE No. C00807
- Acronym
- PAVAV
- Status last verified
- Aug 2008
- First submitted
- 18 Jan 2008
- Last updated
- 27 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fichtner S, Hessling G, Ammar S, Reents T, Estner HL, Jilek C, Kathan S, Buchner M, Dillier R, Deisenhofer I. A prospective randomized study comparing isolation of the arrhythmogenic vein versus all veins in paroxysmal atrial fibrillation. Clin Cardiol. 2013 Jul;36(7):422-6. doi: 10.1002/clc.22132. Epub 2013 May 13.
PubMed 23670880
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PV-Isolation for Paroxysmal Atrial Fibrillation: Isolation of the Arrhythmogenic Vein(s) vs. Isolation of All Veins
- ClinicalTrials.gov ID
- NCT00605748
- Acronym / sponsor ID
- PAVAV / GE IDE No. C00807
- Conditions
- Atrial Fibrillation
- Keywords
- catheter ablation, atrial fibrillation, pulmonary vein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 31 Jan 2008 (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.
We conduct a randomized study comparing the safety and effectiveness of two interventional ablation techniques for treatment of paroxysmal atrial fibrillation: the segmental pulmonary vein ablation approach, (1) with empiric isolation of all pulmonary veins or (2) Segmental Isolation of the arrhythmogenic pulmonary vein(s)
Detailed description
BACKGROUND Atrial fibrillation ablation procedures typically involve isolation of all pulmonary veins (PVs), yet the need for such an extensive ablation strategy in all patients is unclear.
OBJECTIVE:
We conduct a randomized study comparing the safety and effectiveness of two interventional ablation techniques for treatment of paroxysmal atrial fibrillation: the segmental pulmonary vein ablation approach, (1) with empiric isolation of all pulmonary veins or (2) Segmental Isolation of only the arrhythmogenic pulmonary vein(s). The single-blind interventional, randomized study will include 106 patients in each arm.
A reablation procedure, with the use of the same technique as the first ablation, will be offered to the patient in case of a symptomatic atrial fibrillation recurrence beyond the third month after the ablation procedure.
Follow-Up After discharge, patients w ill be scheduled for repeated visits in the arrhythmia clinic at 3 and 6 months after the first ablation. At each of these visits, intensive questioning for arrhythmia-related symptoms (fatigue, dizziness, and nausea) since the last follow-up visit was performed, especially for those that the patient had experienced before ablation. At every follow-up visit, 7-day Holter monitoring w ill be performed. Multislice CT or MRI of the pulmonary vein w ill be obtained before and 3 months after the ablation procedure for evaluation of the pulmonary vein anatomy and for detection of radiofrequency ablation-induced pulmonary vein stenosis .
Study End Points and Definitions The primary end point of the study will be freedom from atrial tachyarrhythmias (of > 30-second duration) including atrial fibrillation and atypical atrial flutter documented by 7-day Holter monitoring performed at the 6-month follow-up. Two secondary study end points will be chosen. The first will be freedom from arrhythmia-related symptoms during the 6-month follow-up. Because early recurrences of atrial tachyarrhythmias within the first month after ablation may be a transient phenomenon, this time interval was excluded from analysis. Second, a composite of periprocedural pericardial tamponade, thromboembolic complications, and pulmonary vein stenosis with > 50% lumen loss (main vessel or first branching) was defined as a safety end point
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Segmental PV-Isolation of the arrhythmogenic vein(s)Segmental PV-Isolation of the arrhythmogenic vein(s) |
| 2 | Active comparator | Procedure: Segmental PV-Isolation of all veinsSegmental PV-Isolation of all veins |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients between 18 and 80 years old with paroxysmal atrial fibrillation
- Episodes with a maximum duration for 7 days
- at least 4 episodes / month
- at least one attempt with Class I or III anti-arrhythmic drugs and/or with ß-blockers without success
- sufficient oral anticoagulation for a minimum of four weeks previous to ablation
Key exclusion criteria (7 listed)
- hyperthyroidism
- mitral regurgitation > II°
- intracardiac thrombi documented by transesophageal echocardiography
- left ventricular ejection< fraction 35%,
- history of ablation, myocardial infarction or cardiac surgery in the previous 3 months
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 |
|---|---|---|
| Segmental PV-Isolation of the arrhythmogenic vein(s)isolation of pulmonary veins for curing atrial fibrillation | Procedure or surgery | 1 |
| Segmental PV-Isolation of all veinsisolation of pulmonary veins for curing atrial fibrillation | Procedure or surgery | 2 |
Primary outcome
freedom of atrial tachycardia 6 months after ablation
Time frame: 6 months
1 secondary outcome
freedom of symptoms due to atrial tachycardia 6 months after ablation safety
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2008.
- Derived from this study: PubMed 23670880Fichtner S, Hessling G, Ammar S, Reents T, Estner HL, Jilek C, Kathan S, Buchner M, Dillier R, Deisenhofer I. A prospective randomized study comparing isolation of the arrhythmogenic vein versus all veins in paroxysmal atrial fibrillation. Clin Cardiol. 2013 Jul;36(7):422-6. doi: 10.1002/clc.22132. Epub 2013 May 13.
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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.
Isabel Deisenhofer, MD study chair
Deutsches Herzzentrum Muenchen
Heidi L. Estner, MD principal investigator
Deutsches Herzzentrum Muenchen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Segmental PV-Isolation of the arrhythmogenic vein(s) and Segmental PV-Isolation of all veins in people with Atrial Fibrillation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
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 5 inclusion and 7 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 27 Aug 2008. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Heidi L. Estner, MD (+49 89 1218 ext. 2020, estner@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
freedom of atrial tachycardia 6 months after ablation (time frame: 6 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 NCT00605748, 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 27 Aug 2008.