Ablation of slow conducting anatomical isthmuses in patients with repaired Tetralogy of Fallot, who undergo reoperation for pulmonary valve replacement and who are at risk for isthmus related ventricular arrhythmias.

Ablation of slow conducting anatomical isthmuses in patients with repaired Tetralogy of Fallot, who undergo reoperation for pulmonary valve replacement and who are at risk for isthmus related ventricular arrhythmias. - Tetralogy of Fallot

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39860

Enrollment

Registered

2013-05-01

Start date

2013-05-15

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

hartaandoeningen, congenitaal Tetralogy of Fallot

Interventions

Intra-operative cryoablation of the slow conducting anatomical isthmuses.

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients with Tetralogy of Fallot, who will undergo pulmonary valve replacement. 2. Patients from the age of eight years.

Exclusion criteria

Exclusion criteria: 1. Inability to sign informed consent by the patient or his legal representative. 2. Inability to comply with the protocol due to hemodynamic instability.

Design outcomes

Primary

Measure	Time frame
The main study parameters are: (1) prevalence and characteristics of slow conducting anatomical isthmuses, (2) inducibility of monomorphic isthmus related VT before intra-operative cryoablation, (3) histological and electrophysiological characteristics of the biopsies taken from slow conducting isthmuses (re-operation) and the unfundibular muscle which is the most frequent location of a potential slow conducting isthmuses later in life (initial repair). The main study endpoints are: (1) achievement of bidirectional conduction block after intra-operative cryoablation, (2) re-inducibility of isthmus dependent monomorphic VT after intra-operative cryoablation and (3) occurrence and recurrence of VA during follow-up.	—

Measure

Time frame

The main study parameters are: (1) prevalence and characteristics of slow conducting anatomical isthmuses, (2) inducibility of monomorphic isthmus related VT before intra-operative cryoablation, (3) histological and electrophysiological characteristics of the biopsies taken from slow conducting isthmuses (re-operation) and the unfundibular muscle which is the most frequent location of a potential slow conducting isthmuses later in life (initial repair). The main study endpoints are: (1) achievement of bidirectional conduction block after intra-operative cryoablation, (2) re-inducibility of isthmus dependent monomorphic VT after intra-operative cryoablation and (3) occurrence and recurrence of VA during follow-up.

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)