Efficacy of Transcatheter Radiofrequency Ablation of Atrial Flutter With Standard Irrigated Catheter With Flexible Tip

Prospective Study to Evaluate the Acute and 6-month Efficacy of Transcatheter Radiofrequency Ablation of Common Atrial Flutter With a Standard Irrigated Catheter With Flexible Tip.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01262443

Enrollment

Registered

2010-12-17

Start date

2010-11-30

Completion date

2014-02-28

Last updated

2016-10-03

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

Conditions

Atrial Flutter

Keywords

Atrial flutter

Brief summary

The purpose of this study is to evaluate the efficacy of transcatheter ablation of atrial flutter with a standard irrigated catheter with flexible tip, as evaluated by percentual success of the procedure.

Detailed description

No more available data

Interventions

PROCEDURERadiofrequency Ablation

Radiofrequency ablation by a standard 4mm irrigated flexible tip catheter

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Both sexes; age\>18 yrs * ECG documentation of at least 2 episodes of common atrial flutter or evidence of ongoing atrial flutter. * No contraindications to transcatheter radiofrequency ablation by a standard 4mm irrigated flexible tip catheter * Patients willing to accept the tests and to follow standard procedures * Patients who understand the nature of the procedure and who are willing to participate and to sign the informed consent before enrollment

Exclusion criteria

* Atrial fibrillation * Any arrhythmia requiring antiarrhythmics in the 6 months post procedure * Intra atrial thrombosis * NYHA class IV * Unstable Angina or Acute Myocardial Infarction (AMI) in the last 3 month * Untreated Wolf Parkinson White syndrome * Contraindications to oral anticoagulation * Life expectancy \< 12 month * Major surgery or interventional procedure already planned in the 6 month following ablation * Pregnancy or breast-feeding * Participation in another study

Design outcomes

Primary

Measure	Time frame	Description
Percentual success of the procedure during the hospitalization	Up to 4 days	Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.
Percentual success of the procedure at 3 months from procedure	3 months	Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.
Percentual success of the procedure at 6 months from procedure	6 months	Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.

Secondary

Measure	Time frame	Description
•Synus rhythm maintenance in the absence of antiarrhythmics within 6 month from procedure.	Up to 4 days; 3-6 month	—
Duration of ablation procedure, number of radiofrequency erogations, duration and total energy given	Up to 4 days	—
Safety of the procedure	Up to 4 days	recording of procedure-related complications

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026