ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 525 for:    Recruiting, Not yet recruiting, Available Studies | "Atrial Fibrillation"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02779660
Recruitment Status : Recruiting
First Posted : May 20, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Jedrzej Kosiuk, Heart Center Leipzig - University Hospital

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Remote ischemic preconditioning (RIPC) Procedure: sham-intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study
Study Start Date : May 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RIPC-Group
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)
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.

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




Primary Outcome Measures :
  1. inducibility of Atrial Fibrillation by high-rate pacing of 20 s [ Time Frame: during the Atrial Fibrillation Ablation procedure ]
  2. sustainability of Atrial Fibrillation measured in seconds [ Time Frame: during the Atrial Fibrillation Ablation procedure ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779660


Contacts
Contact: Jedrzej Kosiuk, MD Jedrzej.Kosiuk@helios-kliniken.de

Locations
Germany
Herzzentrum Leipzig Recruiting
Leipzig, Germany, 04289
Contact: Jedrzej Kosiuk       Jedrzej.Kosiuk@helios-kliniken.de   
Sponsors and Collaborators
Jedrzej Kosiuk

Responsible Party: Jedrzej Kosiuk, MD Jedrzej Kosiuk, Heart Center Leipzig - University Hospital
ClinicalTrials.gov Identifier: NCT02779660     History of Changes
Other Study ID Numbers: RIPPAF V1
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jedrzej Kosiuk, Heart Center Leipzig - University Hospital:
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes