Atrial FibrillationPRECON-AFNCT05342220
Effect of Ischemic Preconditioning on Atrial Fibrillation After Electrocardioversion
A study testing Remote ischemic preconditioning in people with Atrial Fibrillation, run by St. Josefs-Hospital Wiesbaden GmbH at 1 site in Germany.
Trial summary
Remote ischemic preconditioning is one way to influence the success of therapy in cardiovascular patients. By means of remote ischemic preconditioning the incidence of atrial fibrillation after cardiac surgery was reduced by 54%. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Remote ischemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2022to 30 Jun 2024
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with paroxysmal or persistent atrial fibrillation who give written informed consent to participate in the study
- Age > 18 years
- Consent capacity
Who cannot join
- Age under 18 years
- Pregnancy
- Lack of consent capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ischemic Preconditioning on Relapse of Nonvalvular Atrial Fibrillation After Electrocardioversion
Remote ischemic preconditioning is one way to influence the success of therapy in cardiovascular patients. By means of remote ischemic preconditioning the incidence of atrial fibrillation after cardiac surgery was reduced by 54%. The investigators aim to investigate the effect of ischemic preconditioning in an easy-to-perform protocol with regard to the recurrence of atrial fibrillation after electrical cardioversion.
- Conditions
- Atrial Fibrillation
- Being tested
- Remote ischemic preconditioning, Sham preconditioning
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningProcedure or surgery
Remote ischemic preconditioning through inflation of a blood pressure cuff to pressure values > 200mmHg for 5 minutes followed by 5 minutes of reperfusion (3 times each) before electrocardioversion Electrical cardioversion for atrial fibrillation (100, 150, 200 Joule)
Sham preconditioningProcedure or surgery
Inflation of a blood pressure cuff to pressure values ~ 10mmHg for 5 minutes followed by 5 minutes of reperfusion (3 times each) before electrocardioversion
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Preconditioning | Active comparator | Remote ischemic preconditioining Receives: Procedure: Remote ischemic preconditioning |
| Control | Sham comparator | Sham preconditioning Receives: Procedure: Sham preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with recurrence of atrial fibrillation 30 days after electrical cardioversion
Measured: 30 days
Secondary outcomes (5)
Number of patients with short-term cardioversion success
Sinus rhythm lasting > 30 seconds after electrocardioversion
Measured: 30 seconds
Minimum energy required for successful electrocardioversion (in Joule)
Measured: 30 days
Cumulative energy applied for successfull electrocardioversion (in Joule)
Measured: 30 days
Cumulative number of shocks delivered for successfull electrocardioversion
Measured: 30 days
Number of patients experiencing death from any cause, stroke /transient ischemic attack, relevant post-ECV arrhythmia and procedure-associated complications
Safety endpoint
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Apr 2022
- Primary completion31 Mar 2024
- Study completion30 Jun 2024
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Josefs-Hospital Wiesbaden GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342220
- Sponsor's protocol ID
- PRECON
- Acronym
- PRECON-AF
- Status last verified
- Jul 2024
- First submitted
- 6 Apr 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Keim C, Wiedenmann L, Schubert T, Rothe M, Dobre BC, Kaess BM, Ehrlich JR, Boehmer AA. Remote Ischemic Preconditioning for Electrical Cardioversion of Atrial Fibrillation-the Prospective Randomized PRECON-AF Study. CJC Open. 2025 Mar 10;7(5):571-578. doi: 10.1016/j.cjco.2025.03.004. eCollection 2025 May.
PubMed 40433224
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ischemic Preconditioning on Relapse of Nonvalvular Atrial Fibrillation After Electrocardioversion
- ClinicalTrials.gov ID
- NCT05342220
- Acronym / sponsor ID
- PRECON-AF / PRECON
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- St. Josefs-Hospital Wiesbaden GmbHUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 22 Apr 2022 (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.
Remote ischemic preconditioning is one way to influence the success of therapy in cardiovascular patients. By means of remote ischemic preconditioning the incidence of atrial fibrillation after cardiac surgery was reduced by 54%. The investigators aim to investigate the effect of ischemic preconditioning in an easy-to-perform protocol with regard to the recurrence of atrial fibrillation after electrical cardioversion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Preconditioning | Active comparator | Procedure: Remote ischemic preconditioningRemote ischemic preconditioining |
| Control | Sham comparator | Procedure: Sham preconditioningSham preconditioning |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with paroxysmal or persistent atrial fibrillation who give written informed consent to participate in the study
- Age > 18 years
- Consent capacity
Key exclusion criteria (3 listed)
- Age under 18 years
- Pregnancy
- Lack of consent capacity
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 |
|---|---|---|
| Remote ischemic preconditioningRemote ischemic preconditioning through inflation of a blood pressure cuff to pressure values > 200mmHg for 5 minutes followed by 5 minutes of reperfusion (3 times each) before electrocardioversion Electrical cardioversion for atrial fibrillation (100, 150, 200 Joule) | Procedure or surgery | Remote Ischemic Preconditioning |
| Sham preconditioningInflation of a blood pressure cuff to pressure values ~ 10mmHg for 5 minutes followed by 5 minutes of reperfusion (3 times each) before electrocardioversion | Procedure or surgery | Control |
Primary outcome
Number of subjects with recurrence of atrial fibrillation 30 days after electrical cardioversion
Time frame: 30 days
5 secondary outcomes
Number of patients with short-term cardioversion success
Time frame: 30 seconds
Minimum energy required for successful electrocardioversion (in Joule)
Time frame: 30 days
Cumulative energy applied for successfull electrocardioversion (in Joule)
Time frame: 30 days
Cumulative number of shocks delivered for successfull electrocardioversion
Time frame: 30 days
Number of patients experiencing death from any cause, stroke /transient ischemic attack, relevant post-ECV arrhythmia and procedure-associated complications
Time frame: 30 days
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 9 Jul 2024.
- Derived from this study: PubMed 40433224Keim C, Wiedenmann L, Schubert T, Rothe M, Dobre BC, Kaess BM, Ehrlich JR, Boehmer AA. Remote Ischemic Preconditioning for Electrical Cardioversion of Atrial Fibrillation-the Prospective Randomized PRECON-AF Study. CJC Open. 2025 Mar 10;7(5):571-578. doi: 10.1016/j.cjco.2025.03.004. eCollection 2025 May.
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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.
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 Remote ischemic preconditioning in people with Atrial Fibrillation, run by St. Josefs-Hospital Wiesbaden GmbH 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 3 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 9 Jul 2024. 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?
Number of subjects with recurrence of atrial fibrillation 30 days after electrical cardioversion (time frame: 30 days). 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 NCT05342220, 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 9 Jul 2024.