Paroxysmal Atrial FibrillationNCT01724437
Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation
A study testing catheter based pulmonary vein isolation in people with Paroxysmal Atrial Fibrillation and Catheter Ablation Strategies, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
to assess the near-term (12 months) efficacy of pulmonary vein isolation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Catheter Ablation Strategies
- What is being tested?
- catheter based pulmonary vein isolation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Nov 2012
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- written informed consent
- age > 18 years
- paroxysmal atrial fibrillation
Who cannot join
- structural heart disease
- intracardiac thrombus
- reversible causes of atrial fibrillation
- inability to take warfarin
Trial locations and contacts
1 site in 1 country.
About this study
to assess the near-term (12 months) efficacy of pulmonary vein isolation.
Read the detailed description
The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein isolation using a standard approach compared to application of an additional acute procedural endpoint of unexcitability along the ablation line.
- Being tested
- catheter based pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter based pulmonary vein isolationDevice
catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Loss of pace capture | Active comparator | Pulmonary vein isolation: Ablation along the ablation line is continued until loss of pace capture along the ablation line is achieved
catheter based pulmonary vein isolation Receives: Device: catheter based pulmonary vein isolation |
| Conventional | Active comparator | Pulmonary vein isolation: Ablation is discontinued when electrical isolation of the pulmonary veins is achieved.
catheter based pulmonary vein isolation Receives: Device: catheter based pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to AF and AT recurrence
recurrence of AF as assessed by 3 day holter monitoring, assessment of AT recurrence using 3 day holter monitoring
Measured: 12 months
Secondary outcomes (2)
procedure duration
time needed to complete the procedure
Measured: completed (15 months)
procedure safety
complication such as groin hematoma, stroke and pericardial bleed prolonging the hospital stay will be assessed
Measured: up to three days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startNov 2009
- Primary completionNov 2010
- Study completionNov 2012
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 Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Willems, Principal investigator, Universitäres Herzzentrum Hamburg GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724437
- Sponsor's protocol ID
- PV3503
- Status last verified
- Aug 2022
- First submitted
- 4 Nov 2012
- Last updated
- 1 Sep 2022
- Results posted
- No
Publications
Steven D, Sultan A, Reddy V, Luker J, Altenburg M, Hoffmann B, Rostock T, Servatius H, Stevenson WG, Willems S, Michaud GF. Benefit of pulmonary vein isolation guided by loss of pace capture on the ablation line: results from a prospective 2-center randomized trial. J Am Coll Cardiol. 2013 Jul 2;62(1):44-50. doi: 10.1016/j.jacc.2013.03.059. Epub 2013 May 1.
PubMed 23644091
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation
- ClinicalTrials.gov ID
- NCT01724437
- Acronym / sponsor ID
- PV3503
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 9 Nov 2012 (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.
to assess the near-term (12 months) efficacy of pulmonary vein isolation.
Detailed description
The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein isolation using a standard approach compared to application of an additional acute procedural endpoint of unexcitability along the ablation line.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loss of pace capture | Active comparator | Device: catheter based pulmonary vein isolationPulmonary vein isolation: Ablation along the ablation line is continued until loss of pace capture along the ablation line is achieved catheter based pulmonary vein isolation |
| Conventional | Active comparator | Device: catheter based pulmonary vein isolationPulmonary vein isolation: Ablation is discontinued when electrical isolation of the pulmonary veins is achieved. catheter based pulmonary vein isolation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- written informed consent
- age > 18 years
- paroxysmal atrial fibrillation
Key exclusion criteria (4 listed)
- structural heart disease
- intracardiac thrombus
- reversible causes of atrial fibrillation
- inability to take warfarin
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 |
|---|---|---|
| catheter based pulmonary vein isolationcatheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice | Device | Conventional, Loss of pace capture |
Primary outcome
time to AF and AT recurrence
Time frame: 12 months
recurrence of AF as assessed by 3 day holter monitoring, assessment of AT recurrence using 3 day holter monitoring
2 secondary outcomes
procedure duration
Time frame: completed (15 months)
procedure safety
Time frame: up to three days after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Derived from this study: PubMed 23644091Steven D, Sultan A, Reddy V, Luker J, Altenburg M, Hoffmann B, Rostock T, Servatius H, Stevenson WG, Willems S, Michaud GF. Benefit of pulmonary vein isolation guided by loss of pace capture on the ablation line: results from a prospective 2-center randomized trial. J Am Coll Cardiol. 2013 Jul 2;62(1):44-50. doi: 10.1016/j.jacc.2013.03.059. Epub 2013 May 1.
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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.
Stephan Willems principal investigator
Universitäres Herzzentrum Hamburg GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing catheter based pulmonary vein isolation in people with Paroxysmal Atrial Fibrillation and Catheter Ablation Strategies, run by Universitätsklinikum Hamburg-Eppendorf 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 1 Sep 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
time to AF and AT recurrence (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 NCT01724437, 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 1 Sep 2022.