Paroxysmal Atrial FibrillationNCT05959798
High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation
An observational study of Paroxysmal Atrial Fibrillation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation: safety and acute procedural outcome Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- High power short duration ablation
- Type of treatment
- Surgery or procedure
- How many people
- 204 participants
- Where
- 1 siteGermany
- Study dates
- 20 Apr 2019to 17 Jul 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients with documented paroxysmal atrial fibrillation, not previously treated by left atrial catheter ablation
Who may be able to join
- symptomatic, documented, drug-resistent paroxysmal atrial fibrillation
- effective oral anticoagulation
Who cannot join
- any prior left atrial ablation procedure
- presence of left atrial thrombus
- secondary atrial fibrillation due to electrolyte imbalance or thyroid disease
- any prior oesophageal or gastric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation: Safety and Acute Procedural Outcome
High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation: safety and acute procedural outcome
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- High power short duration ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High power short duration ablationProcedure or surgery
Pulmonary vein isolation by high power short duration radiofrequency catheter ablation
| Study group | Role | What they receive |
|---|---|---|
| High power short duration ablation | Not described Receives: Procedure: High power short duration ablation | |
| Moderate power long duration ablation | Not described Receives: Procedure: High power short duration ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of reconnected pulmonary veins 20 minutes after ablation in comparison of both ablation groups
Measured: Acute endpoint
Secondary outcomes (1)
Time to first documented recurrence of atrial fibrillation after a 6-week blanking period.
Measured: 12 months after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start20 Apr 2019
- Primary completion17 Jul 2023
- Study completion17 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabel Deisenhofer, Prof. Dr., Principal investigator, Deutsches Herzzentrum München, Abt. für Elektrophysiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959798
- Sponsor's protocol ID
- POWER PULSE
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation: Safety and Acute Procedural Outcome
- ClinicalTrials.gov ID
- NCT05959798
- Acronym / sponsor ID
- POWER PULSE
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- 20 Apr 2019 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 17 Jul 2023 (actual)
- First posted
- 25 Jul 2023 (actual)
- 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.
High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation: safety and acute procedural outcome
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High power short duration ablation | – | Procedure: High power short duration ablation |
| Moderate power long duration ablation | – | Procedure: High power short duration ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with documented paroxysmal atrial fibrillation, not previously treated by left atrial catheter ablation
Key inclusion criteria (2 listed)
- symptomatic, documented, drug-resistent paroxysmal atrial fibrillation
- effective oral anticoagulation
Key exclusion criteria (4 listed)
- any prior left atrial ablation procedure
- presence of left atrial thrombus
- secondary atrial fibrillation due to electrolyte imbalance or thyroid disease
- any prior oesophageal or gastric surgery
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 |
|---|---|---|
| High power short duration ablationPulmonary vein isolation by high power short duration radiofrequency catheter ablation | Procedure or surgery | High power short duration ablation, Moderate power long duration ablation |
Primary outcome
Number of reconnected pulmonary veins 20 minutes after ablation in comparison of both ablation groups
Time frame: Acute endpoint
1 secondary outcome
Time to first documented recurrence of atrial fibrillation after a 6-week blanking period.
Time frame: 12 months after ablation
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 25 Jul 2023.
- Individual participant dataSharing planned: No
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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, Prof. Dr. principal investigator
Deutsches Herzzentrum München, Abt. für Elektrophysiologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal 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 2 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 25 Jul 2023. 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 veins 20 minutes after ablation in comparison of both ablation groups (time frame: Acute endpoint). 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 25 Jul 2023.