NCT02779660

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

May 12, 2016

Last Update Submit

August 17, 2017

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • inducibility of Atrial Fibrillation by high-rate pacing of 20 s

    during the Atrial Fibrillation Ablation procedure

  • sustainability of Atrial Fibrillation measured in seconds

    during the Atrial Fibrillation Ablation procedure

Study Arms (2)

RIPC-Group

EXPERIMENTAL

After randomization patients will undergo 3 sessions of RIPC (Remote ischemic preconditioning) intervention: I) on preoperative day, II) 1 h before and III) directly before the blood sample collection and invasive measurement of electrophysiological parameters.

Procedure: Remote ischemic preconditioning (RIPC)

Control-Group

PLACEBO COMPARATOR

After randomization patients will undergo 3 sessions of sham-intervention: I) on preoperative day, II) 1 h before and III) directly before the blood sample collection and invasive measurement of electrophysiological parameters.

Procedure: sham-intervention

Interventions

Remote ischemic preconditioning (RIPC)PROCEDURE

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.

RIPC-Group
sham-interventionPROCEDURE

In the control group the cuff will be inflated for 3 times at 10 mm Hg for 5 minutes with 5-minute intervals

Control-Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • planned invasive Atrial Fibrillation ablation

You may not qualify if:

  • AF in ECG at Admission
  • history of AF ablation
  • age \<18
  • pregnancy
  • neoplastic disorders
  • acute or systemic inflammation, autoimmune diseases
  • documented atrial flutter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzzentrum Leipzig

Leipzig, 04289, Germany

RECRUITING

Related Publications (1)

  • Kosiuk J, Langenhan K, Stegmann C, Uhe T, Dagres N, Dinov B, Kircher S, Richter S, Sommer P, Bertagnolli L, Bollmann A, Hindricks G. Effect of remote ischemic preconditioning on electrophysiological parameters in nonvalvular paroxysmal atrial fibrillation: The RIPPAF Randomized Clinical Trial. Heart Rhythm. 2020 Jan;17(1):3-9. doi: 10.1016/j.hrthm.2019.07.026. Epub 2019 Jul 26.

    PMID: 31356986DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jedrzej Kosiuk, MD

CONTACT

Jedrzej.Kosiuk@helios-kliniken.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD Jedrzej Kosiuk

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 20, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2018

Study Completion

September 1, 2018

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

DE(1)