Improving Outcome After Pulmonary Vein IsolationFULL CONTACTNCT02816268
Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
A study testing Pulmonary vein isolation in people with Improving Outcome After Pulmonary Vein Isolation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
The investigators prospectively investigate the differences between contact-force guided pulmonary vein isolation (PVI) and conventional pulmonary vein isolation in patients with paroxysmal atrial fibrillation (PAF) with respect to adenosine guided unmasking of dormant conduction, procedural and clinical outcome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Improving Outcome After Pulmonary Vein Isolation
- What is being tested?
- Pulmonary vein isolation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Nov 2015
- 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 Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients (>=18 und < 80 years) with symptomatic paroxysmal AF
- At least one unsuccessful attempt of antiarrhythmic drug (betablocker or class I oder III).
- Oral anticoagulation with phenprocoumone, warfarine or DOAKs for at least 4 weeks prior to ablation with weekly documented INR > 2..
- Withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone.
Who cannot join
- Left atrial thrombus
- Contraindications for oral anticoagulation or adenosin
Trial locations and contacts
1 site in 1 country.
About this study
The investigators prospectively investigate the differences between contact-force guided pulmonary vein isolation (PVI) and conventional pulmonary vein isolation in patients with paroxysmal atrial fibrillation (PAF) with respect to adenosine guided unmasking of dormant conduction, procedural and clinical outcome.
- Being tested
- Pulmonary vein isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolationOther
| Study group | Role | What they receive |
|---|---|---|
| Conventional Pulmonary vein isolation | Other | Conventional pulmonary vein isolation was gained by using an irrigated tip ablation catheter Receives: Other: Pulmonary vein isolation |
| Contact force pulmonary vein isolation | Other | Contact force was meassured by using the SMART-Touch ablation catheter (Biosense-Webster®) Receives: Other: Pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of reconnected pulmonary vein after ablation and a waíting period of 20min
Measured: 20min after procedure
Secondary outcomes (3)
Time to first documented recurrence of atrial fibrillation
Measured: 12 month
Complications due to ablation
Measured: 30 days
Number of reconnected pulmonary veins
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startSep 2012
- Primary completionMay 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improving Outcome After Pulmonary Vein IsolationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816268
- Sponsor's protocol ID
- GER-EP-DHM-21
- Acronym
- FULL CONTACT
- Status last verified
- Jun 2016
- First submitted
- 24 Jun 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02816268
- Acronym / sponsor ID
- FULL CONTACT / GER-EP-DHM-21
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 28 Jun 2016 (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 investigators prospectively investigate the differences between contact-force guided pulmonary vein isolation (PVI) and conventional pulmonary vein isolation in patients with paroxysmal atrial fibrillation (PAF) with respect to adenosine guided unmasking of dormant conduction, procedural and clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Pulmonary vein isolation | Other | Other: Pulmonary vein isolationConventional pulmonary vein isolation was gained by using an irrigated tip ablation catheter |
| Contact force pulmonary vein isolation | Other | Other: Pulmonary vein isolationContact force was meassured by using the SMART-Touch ablation catheter (Biosense-Webster®) |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients (>=18 und < 80 years) with symptomatic paroxysmal AF
- At least one unsuccessful attempt of antiarrhythmic drug (betablocker or class I oder III).
- Oral anticoagulation with phenprocoumone, warfarine or DOAKs for at least 4 weeks prior to ablation with weekly documented INR > 2..
- Withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone.
Key exclusion criteria (2 listed)
- Left atrial thrombus
- Contraindications for oral anticoagulation or adenosin
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 |
|---|---|---|
| Pulmonary vein isolation | Other | Contact force pulmonary vein isolation, Conventional Pulmonary vein isolation |
Primary outcome
Number of reconnected pulmonary vein after ablation and a waíting period of 20min
Time frame: 20min after procedure
3 secondary outcomes
Time to first documented recurrence of atrial fibrillation
Time frame: 12 month
Complications due to ablation
Time frame: 30 days
Number of reconnected pulmonary veins
Time frame: 12 month
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 28 Jun 2016.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein isolation in people with Improving Outcome After Pulmonary Vein Isolation, 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 4 inclusion and 2 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 28 Jun 2016. 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?
Number of reconnected pulmonary vein after ablation and a waíting period of 20min (time frame: 20min after procedure). 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 28 Jun 2016.