Health TrialsbyHealthPanel

The DefiPace Study

ConditionPost-operative Atrial Fibrillation POAF
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut für Pharmakologie und Präventive Medizin

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Phase A Approximately 150 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) Phase B Approximately 300 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) with planned TMA implantation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    no intervention

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: Phase A1 intervention
Group B: Phase B1 intervention

Trial outcomes

Primary outcomes

1

Incidence of POAF

Incidence of POAF

Time frame
30 days
2

Termination of POAF

Termination of POAF

Time frame
30 days
3

Time in POAF

Time in POAF (AF Burden)

Time frame
30 days
4

Time to cardioversion

Median time to cardioversion

Time frame
30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut für Pharmakologie und Präventive Medizin

Lead sponsor

Osypka AG

Collaborator

Source ClinicalTrials.gov
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