Atrial FibrillationNCT00982475
Alster Man and Machine: Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation
A study testing Pulmonary vein isolation with radiofrequency current in people with Atrial Fibrillation, run by Dr. Kai Jaquet at 1 site in Germany.
Trial summary
Long term results after pulmonary vein isolation (PVI) with robotic navigation in patients with drug refractory atrial fibrillation are not inferior to manual radiofrequency current ablation. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pulmonary vein isolation with radiofrequency current
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to 27 Feb 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- paroxysmal atrial fibrillation
- persistent atrial fibrillation < 2 month
- indication for catheter ablation
- LEF > 50%
- diameter LA < 50 mm
Who cannot join
- intracardial thrombus
- atrial fibrillation with underlying curable disease
- renal failure > stage I
- contraindication for anticoagulation
- life expectancy < 12 month
- previous PVI
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ablation at St. George Hospital - Prospective Randomized Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation
Long term results after pulmonary vein isolation (PVI) with robotic navigation in patients with drug refractory atrial fibrillation are not inferior to manual radiofrequency current ablation.
- Conditions
- Atrial Fibrillation
- Being tested
- Pulmonary vein isolation with radiofrequency current
- Keywords
- pulmonary vein isolation, robotic navigation, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolation with radiofrequency currentProcedure or surgery
Pulmonary vein isolation with radiofrequency current
| Study group | Role | What they receive |
|---|---|---|
| PVI with robotic navigation | Active comparator | Not described Receives: Procedure: Pulmonary vein isolation with radiofrequency current |
| PVI manually | Placebo comparator | Not described Receives: Procedure: Pulmonary vein isolation with radiofrequency current |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom of AF 12 months after procedure.
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 posted23 Sep 2009 (estimated)
- Study startSep 2009
- Primary completion27 Feb 2018
- Study completion27 Feb 2018
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Kai Jaquet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott Medical Devices, Hansen Medical
- Responsible party
- Sponsor-investigator, Dr. Kai Jaquet, Asklepios proresearch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982475
- Sponsor's protocol ID
- 1889
- Status last verified
- Mar 2018
- First submitted
- 22 Sep 2009
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Rillig A, Schmidt B, Di Biase L, Lin T, Scholz L, Heeger CH, Metzner A, Steven D, Wohlmuth P, Willems S, Trivedi C, Galllinghouse JG, Natale A, Ouyang F, Kuck KH, Tilz RR. Manual Versus Robotic Catheter Ablation for the Treatment of Atrial Fibrillation: The Man and Machine Trial. JACC Clin Electrophysiol. 2017 Aug;3(8):875-883. doi: 10.1016/j.jacep.2017.01.024. Epub 2017 Jun 28.
PubMed 29759785
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation at St. George Hospital - Prospective Randomized Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00982475
- Acronym / sponsor ID
- 1889
- Conditions
- Atrial Fibrillation
- Keywords
- pulmonary vein isolation, robotic navigation, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Dr. Kai JaquetIndustry (pharma, biotech, devices)
- Collaborators
- Abbott Medical Devices, Hansen Medical
- Study start
- Sep 2009
- Primary completion
- 27 Feb 2018 (actual)
- Study completion
- 27 Feb 2018 (actual)
- First posted
- 23 Sep 2009 (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.
Long term results after pulmonary vein isolation (PVI) with robotic navigation in patients with drug refractory atrial fibrillation are not inferior to manual radiofrequency current ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI with robotic navigation | Active comparator | Procedure: Pulmonary vein isolation with radiofrequency current |
| PVI manually | Placebo comparator | Procedure: Pulmonary vein isolation with radiofrequency current |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- paroxysmal atrial fibrillation
- persistent atrial fibrillation < 2 month
- indication for catheter ablation
- LEF > 50%
- diameter LA < 50 mm
Key exclusion criteria (7 listed)
- intracardial thrombus
- atrial fibrillation with underlying curable disease
- renal failure > stage I
- contraindication for anticoagulation
- life expectancy < 12 month
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 with radiofrequency currentPulmonary vein isolation with radiofrequency current | Procedure or surgery | PVI manually, PVI with robotic navigation |
Primary outcome
Freedom of AF 12 months after procedure.
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 7 Mar 2018.
- Derived from this study: PubMed 29759785Rillig A, Schmidt B, Di Biase L, Lin T, Scholz L, Heeger CH, Metzner A, Steven D, Wohlmuth P, Willems S, Trivedi C, Galllinghouse JG, Natale A, Ouyang F, Kuck KH, Tilz RR. Manual Versus Robotic Catheter Ablation for the Treatment of Atrial Fibrillation: The Man and Machine Trial. JACC Clin Electrophysiol. 2017 Aug;3(8):875-883. doi: 10.1016/j.jacep.2017.01.024. Epub 2017 Jun 28.
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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.
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 with radiofrequency current in people with Atrial Fibrillation, run by Dr. Kai Jaquet 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: finished, as of the sponsor's last update on 7 Mar 2018. 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. Some participants in this study may receive a placebo. 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?
Freedom of AF 12 months after procedure. (time frame: 12 month). 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 NCT00982475, 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 7 Mar 2018.