Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study

Atrial Fibrillation Clinical Trial

— RIPPAF  

Official title:

Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02779660
• Other study ID #: RIPPAF V1
• Status: Recruiting
• Phase: N/A
• First received: May 12, 2016
• Last updated: August 17, 2017
• Start date: May 2016
• Est. completion date: September 2018

Study information

• Verified date: August 2017
• Source: Heartcenter Leipzig GmbH
• Contact: Jedrzej Kosiuk, MD
• Email: Jedrzej.Kosiuk[@]helios-kliniken.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to examine the effect of RIPC on physiological parameters in non-valvular paroxysmal atrial fibrillation. Furthermore the study will provide a unique bio-date base for further analysis of molecular and genetic mechanisms responsible for observed results.

The potential effect of RIPC on AF inducibility and/or prothrombotic activity might be implemented as additional treatment component to reduce AF burden and minimize thromboembolic risk.

Interim Analysis will be done after 73 patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: September 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• planned invasive Atrial Fibrillation ablation

Exclusion Criteria:

• AF in ECG at Admission

• history of AF ablation

• age <18

• pregnancy

• neoplastic disorders

• acute or systemic inflammation, autoimmune diseases

• documented atrial flutter

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Remote ischemic preconditioning (RIPC)
RIPC will be induced by the application of 3 short episodes (5 minutes) of forearm ischemia by cuff sphygmomanometer inflation separated by 5 minutes of reperfusion.
• sham-intervention
In the control group the cuff will be inflated for 3 times at 10 mm Hg for 5 minutes with 5-minute intervals

Locations

Country	Name	City	State
Germany	Herzzentrum Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Jedrzej Kosiuk

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inducibility of Atrial Fibrillation by high-rate pacing of 20 s		during the Atrial Fibrillation Ablation procedure
Primary	sustainability of Atrial Fibrillation measured in seconds		during the Atrial Fibrillation Ablation procedure