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Prognosis and Interdependence of heart Rhythm and AtrioveNtricular Heart vAlve regurgitation in patients undergoing rhythm control therapy or interventional valve treatment

Prognosis and Interdependence of heart Rhythm and AtrioveNtricular Heart vAlve regurgitation in patients undergoing rhythm control therapy or interventional valve treatment - PIRANHA-Trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00035325
Enrollment
400
Registered
2024-10-22
Start date
2024-12-25
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I48.0

Interventions

Group 1: Patients with at least moderate AV valve regurgitation undergoing a rhythm control strategy (electrical cardioversion or catheter ablation) for persistent atrial fibrillation. As part of the

Sponsors

Universitätsherzzentrum Freiburg-Bad Krozingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 2. Written informed consent for study participation prior to enrollment (only applicable for prospective study part) 3. Ability to understand the nature of the trial and the trial related procedures and to comply with them (only applicable for prospective study part) 4. = moderate MR or TR Additional criterion for the rhythm control group: 1. A diagnosis of persistent AFib or atypical atrial flutter and an applied rhythm control (EC/CA) during baseline visit

Exclusion criteria

Exclusion criteria: 1. Prior cardiac surgery, left atrial catheter ablation 2. Patients with primary MR/TR 3. Patients with secondary MR/TR due to endocarditis 4. Short life expectancy due to comorbid conditions 5. Severe aortic valvulopathy (= Grade 3) 6. Acute inflammatory or infectious disease 7. Implant of CRT or CRT-D within the last 30 days 8. CIED related TR Additional Exclusion criterion for the rhythm control group (group 1) 1. Prior transcatheter edge-to-edge repair of MR/TR Additional Exclusion criterion for the TEER group (group 2) 1. Applied rhythm control (CA or EC) during baseline stay

Design outcomes

Primary

MeasureTime frame
AV valve regurgitation severity

Secondary

MeasureTime frame
atrial dilation AF burden

Countries

Germany

Contacts

Public ContactLena Koch

Universitätsherzzentrum Freiburg Bad Krozingen

lena.koch@uniklinik-freiburg.de+491729303236

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026