Sequence of invasive cardiac care pathways for patients with chronic heart failure, atrial fibrillation and mitral valve insufficiency

Sequence of invasive cardiac care pathways for patients with chronic heart failure, atrial fibrillation and mitral valve insufficiency - INCEPTION-PILOT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036834

Enrollment

Registered

2025-05-07

Start date

2024-11-01

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

Heart failure, mitral valve insufficiency, atrial fibrillation, interventional therapy, edge-to-edge repair, pulmonary vein isolation

Interventions

Group 1: Pulmonary vein isolation (PVI) followed by transcatheter edge-to-edge repair of the mitral valve (M-TEER) Group 2: Transcatheter edge-to-edge repair of the mitral valve (M-TEER) followed by p

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Paroxysmal or persistent atrial fibrillation with indication for pulmonary vein isolation. - Mitral valve insufficiency (predominantly functional etiology) requiring treatment with indication for catheter-based repair - NYHA = II

Exclusion criteria

Exclusion criteria: - Significant language barrier - Previous pulmonary vein isolation within the last 3 months - Left atrial appendage thrombus - Serious contraindications to oral anticoagulant therapy - Patients with acute myocardial infarction, elective coronary intervention, cardiac surgery, or pacemaker implantation one month prior to the first planned procedure according to the study protocol. - Walking distance < 50 m within the 6 minute walking distance test

Design outcomes

Primary

Measure	Time frame
Composite primary endpoint of quality of life, hospitalization due to heart failure or hospitalization due to atrial fibrillation recurrence after 12 months.	—

Secondary

Measure	Time frame
- Long-term atrial fibrillation burden - Cardiopulmonary exercise capacity (NYHA stage, 6-minute walk test) - The impact of frailty (Katz index) on procedural outcomes and clinical endpoints - Anatomical and hemodynamic changes in mitral valve regurgitation, cardiac cavities, and associated heart valve defects, determined longitudinally using 2D/3D, and strain analysis in transthoracic echocardiography. - Correlation of the extent of (left) atrial fibrosis with procedural success of PVI, left atrial size, and clinical endpoints. - The impact of different mitral valve insufficiency subtypes on clinical endpoints and procedural outcomes. - Cardiac output determined non-invasively using pulse wave contour	—

Measure

Time frame

- Long-term atrial fibrillation burden - Cardiopulmonary exercise capacity (NYHA stage, 6-minute walk test) - The impact of frailty (Katz index) on procedural outcomes and clinical endpoints - Anatomical and hemodynamic changes in mitral valve regurgitation, cardiac cavities, and associated heart valve defects, determined longitudinally using 2D/3D, and strain analysis in transthoracic echocardiography. - Correlation of the extent of (left) atrial fibrosis with procedural success of PVI, left atrial size, and clinical endpoints. - The impact of different mitral valve insufficiency subtypes on clinical endpoints and procedural outcomes. - Cardiac output determined non-invasively using pulse wave contour

—

Countries

Germany

Contacts

Public ContactKerstin Piayda

Universitätsklinikum Gießen und Marburg - Standort Gießen

kerstinpiayda@gmail.com+49 641 985 42635

Outcome results

None listed

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