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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05342220
Other study ID # PRECON
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date March 31, 2024

Study information

Verified date February 2024
Source St. Josefs-Hospital Wiesbaden GmbH
Contact Joachim R Ehrlich, MD
Phone +496111771201
Email jehrlich@joho.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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%. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date March 31, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Patients with paroxysmal or persistent atrial fibrillation who give written informed consent to participate in the study - Age > 18 years - Consent capacity Exclusion Criteria: - Age under 18 years - Pregnancy - Lack of consent capacity

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Remote ischemic preconditioning
Remote ischemic preconditioning through inflation of a blood pressure cuff to systolic blood pressure values > 200mmHg for 5 minutes (3 times) each before electrocardioversion Electrical cardioversion for atrial fibrillation (100, 150, 200 Joule)
Sham preconditioning
Inflation of a blood pressure cuff to systolic blood pressure values ~ 20mmHg for 5 minutes (3 times) each before electrocardioversion

Locations

Country Name City State
Germany St. Josefs-Hospital Wiesbaden Wiesbaden Hessen

Sponsors (1)

Lead Sponsor Collaborator
St. Josefs-Hospital Wiesbaden GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of subjects with recurrence of atrial fibrillation 30 days after electrical cardioversion 30 days
Secondary Minimum energy required for successful electrocardioversion (in Joule) 30 days
Secondary Cumulative energy applied for successfull electrocardioversion (in Joule) 30 days
Secondary Cumulative number of shocks delivered for successfull electrocardioversion 30 days
Secondary Number of patients with short-term cardioversion success Sinus rhythm after electrocardioversion 30 minutes
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