A combined transvenous and epicardial lead placement procedure for implantation of cardiac resynchronization devices: a feasibility study

A combined transvenous and epicardial lead placement procedure for implantation of cardiac resynchronization devices: a feasibility study - Combined transvenous and epicardial lead placement for CRT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40512

Enrollment

Registered

2014-02-26

Start date

2014-03-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Heart failure pump failure

Interventions

All patients undergo implantation of a CRT device via a combined transvenous and epicardial approach.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Left ventricular ejection fraction 119 ms of >129 ms and presence of left bundle branch block. 3. On optimal medical therapy for heart failure. 4. No sidebranch of the coronary sinus near the posterolateral wall of the left ventricle and/or presence of a Thebesian valve which reduces coronary sinus diameter 50% or more (corresponding to a decrease in cross sectional area of 75% or more). 5. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous intrathoracic surgery 2. Coronary ischemia or recent myocardial infarction (

Design outcomes

Primary

Measure	Time frame
Number of succesful device implantations. The procedure is considerd succesfol when implantation of a CRT device succeeds in all study patients through the procedure described above.	—

Secondary

Measure	Time frame
1. Safety. The procedure is considerd safe when no procedure related deaths occur and procedure related complications occur in three patients or less. 2. Conversion to minithoracotomy.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)