- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02779660
Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study (RIPPAF)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jedrzej Kosiuk, MD
- Email: Jedrzej.Kosiuk@helios-kliniken.de
Study Locations
-
-
-
Leipzig, Germany, 04289
- Recruiting
- Herzzentrum Leipzig
-
Contact:
- Jedrzej Kosiuk
- Email: Jedrzej.Kosiuk@helios-kliniken.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
In the control group the cuff will be inflated for 3 times at 10 mm Hg for 5 minutes with 5-minute intervals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
inducibility of Atrial Fibrillation by high-rate pacing of 20 s
Time Frame: during the Atrial Fibrillation Ablation procedure
|
during the Atrial Fibrillation Ablation procedure
|
sustainability of Atrial Fibrillation measured in seconds
Time Frame: during the Atrial Fibrillation Ablation procedure
|
during the Atrial Fibrillation Ablation procedure
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIPPAF V1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation
-
Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
-
AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
-
Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
-
St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom
-
R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
Clinical Trials on Remote ischemic preconditioning (RIPC)
-
Medical University of LodzCompletedRemote Ischemic Preconditioning | Contrast Induced - Acute Kidney InjuryPoland
-
Institut für Pharmakologie und Präventive MedizinWithdrawnEffectivity of RIPC in Outcomes of TAVI ProcedureGermany
-
Xijing HospitalUnknownCardiac Surgery PatientsChina
-
Beijing Tiantan HospitalPeking University International HospitalSuspendedMoyamoya Disease | Remote Ischemic PreconditioningChina
-
VA Office of Research and DevelopmentRecruitingHeart Failure | Acute Kidney Injury | Percutaneous Coronary Intervention | Contrast Induced Nephropathy | Coronary AngiographyUnited States
-
Westfälische Wilhelms-Universität MünsterRecruitingSepsis | Acute Kidney Injury | Critically IllGermany
-
University Hospital MuensterElse Kröner Fresenius FoundationUnknownCardiac Surgery, Aortocoronary BypassGermany
-
Beijing Anzhen HospitalUnknown
-
Ji XunmingCompletedCarotid Artery StenosisChina