search
Back to results

Effect of Ischemic Preconditioning on Atrial Fibrillation After Electrocardioversion (PRECON-AF)

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Remote ischemic preconditioning
Sham preconditioning
Sponsored by
St. Josefs-Hospital Wiesbaden GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Josefs-Hospital WiesbadenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Remote Ischemic Preconditioning

Control

Arm Description

Remote ischemic preconditioining

Sham preconditioning

Outcomes

Primary Outcome Measures

Number of subjects with recurrence of atrial fibrillation 30 days after electrical cardioversion

Secondary Outcome Measures

Minimum energy required for successful electrocardioversion (in Joule)
Cumulative energy applied for successfull electrocardioversion (in Joule)
Cumulative number of shocks delivered for successfull electrocardioversion
Number of patients with short-term cardioversion success
Sinus rhythm after electrocardioversion

Full Information

First Posted
April 6, 2022
Last Updated
June 17, 2022
Sponsor
St. Josefs-Hospital Wiesbaden GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT05342220
Brief Title
Effect of Ischemic Preconditioning on Atrial Fibrillation After Electrocardioversion
Acronym
PRECON-AF
Official Title
Effect of Ischemic Preconditioning on Relapse of Nonvalvular Atrial Fibrillation After Electrocardioversion
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Josefs-Hospital Wiesbaden GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remote Ischemic Preconditioning
Arm Type
Active Comparator
Arm Description
Remote ischemic preconditioining
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Sham preconditioning
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic preconditioning
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Sham preconditioning
Intervention Description
Inflation of a blood pressure cuff to systolic blood pressure values ~ 20mmHg for 5 minutes (3 times) each before electrocardioversion
Primary Outcome Measure Information:
Title
Number of subjects with recurrence of atrial fibrillation 30 days after electrical cardioversion
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Minimum energy required for successful electrocardioversion (in Joule)
Time Frame
30 days
Title
Cumulative energy applied for successfull electrocardioversion (in Joule)
Time Frame
30 days
Title
Cumulative number of shocks delivered for successfull electrocardioversion
Time Frame
30 days
Title
Number of patients with short-term cardioversion success
Description
Sinus rhythm after electrocardioversion
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joachim R Ehrlich, MD
Phone
+496111771201
Email
jehrlich@joho.de
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Boehmer, MD
Phone
+496111771201
Email
aboehmer@joho.de
Facility Information:
Facility Name
St. Josefs-Hospital Wiesbaden
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65189
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joachim R Ehrlich, MD
Phone
+496111771201
Email
jehrlich@joho.de

12. IPD Sharing Statement

Learn more about this trial

Effect of Ischemic Preconditioning on Atrial Fibrillation After Electrocardioversion

We'll reach out to this number within 24 hrs