NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

The DefiPace Study

RecruitingN/A

Sponsor: Institut für Pharmakologie und Präventive Medizin

Conditions: Post-operative Atrial Fibrillation POAF

Interventions: No intervention

Countries: Austria, Germany

Prospective, non-interventional, multi-center, international registry in two phases in consecutive patients undergoing elective cardiac surgery. The DefiPace registry is designed in two phases 1. to document the standard of care in 50 patients with atrial fibrillation (AF) 2. to assess the treatment and outcomes of patients with post-operative atrial fibrilllation using low-energy cardioversion and subsequent bi-atrial pacing in clinical practice in 100 patients

Eligibility overview

Sex: ALL

Age: 18 Years to —

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Patient is scheduled to undergo elective open chest cardiac surgery (bypass and / or valve surgery)
* Patient is at least 18 years old
* Patient with isolated bypass surgery is at least 70 years old
* Patient with valve surgery is at least 60 years old
* Patient provides written informed consent prior to the procedure
* Phase B only: patient is scheduled for TMA implantation during the elective cardiac surgery and is potentially eligible for DefiPace use

Exclusion Criteria:

* Clinical history of either permanent, persistend or paroxysmal atrial fibrillation
* Permanent pacemaker/defibrillator, other intra-cardiac active implanted electronic devices
* Minimally-invasive surgery
* Recent stroke within the last 3 months
* A history of or current endocarditis
* Pregnacy at the time of surgery

Locations (10)

Vienna, Austria
Erlangen, Bavaria, Germany
Nuremberg, Bavaria, Germany
Würzburg, Bavaria, Germany
Oldenburg, Lower Saxony, Germany
Dresden, Saxony, Germany
Freiburg im Breisgau, Germany
Hanover, Germany
Jena, Germany
Ulm, Germany