Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07012460

Pulsed Field Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter Cohort Study

Pulsed field ablation (PFA) has been demonstrated to be safe and effective in achieving pulmonary vein isolation in patients with atrial fibrillation (AF). Coexisting atrial flutter is common in patients with AF. It is therefore appealing to treat the atrial futters with PFA. The use of PFA for extra-pulmonary ablation, such as linear ablation at the mitral or cavo-tricuspid isthmus (CTI) has been investigated. When PFA is applied near a coronary vessel, acute coronary spasm is a common observation, which has been reported to be reversible and largely mitigated by pre-emptive intravenous or intracoronary nitroglycerine (TNG) injection. A recent clinical study based on qualitative coronary angiogram reported no apparent coronary stenosis 6 months after PFA. However, quantitative measurements were not provided. While acute conduction block is easy to create with pulsed field ablation catheters, the long-term lesion durability is unknown. The circular array pulsed field ablation catheter was shown to be safe and effective in achieving pulmonary vein isolation. This study aims to evaluate the safety and efficacy of pulsed-field ablation for CTI flutters.

This study will be a multicenter prospective cohort study involving 30 patients undergoing ablation for atrial fibrillation and CTI flutter. The decision for ablation will be a clinical decision based on existing class I and II guideline recommendations.

The atrial fibrillation ablation procedure will be performed as per routine clinical practice. Procedure will be performed with a 3-D electro-anatomical system guidance. Pulmonary vein isolation (PVI) will be performed with pulsed field ablation with a circular array catheter (Pulse Select system, Medtronic). After confirming PVI, extrapulmonary ablation will be performed per clinically need. CTI ablation will be performed with PFA as planned.

Patient will be managed by usual clinical care after ablation. They will come back for follow up at 3 months for a remapping procedure. During the remapping procedure, a RCA coronary angiogram will be performed to exclude late coronary damage. A multipolar catheter will be inserted via right femoral vein to check for conduction block across CTI. If there is ongoing conduction, a repeat ablation will be performed with radiofrequency ablation.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with atrial fibrillation who are clinically planned to undergo AF ablation and atrial flutter ablation per guideline recommendations

Exclusion criteria

  • >80 years old or <18 years old
  • Known severe coronary artery disease
  • Prior history of atrial flutter or atrial fibrillation ablation
  • Refusal for remapping or coronary angiogram
  • Contraindication for coronary angiogram
  • Pregnancy
  • Expected life expectancy <1 year
  • Inability to provide informed consent

Treatment and study plan

CTI ablation

Device

CTI ablation will be performed with PFA. Before ablation, The RA geometry will be created with a multipolar catheter. Coronary angiogram will be performed at baseline in LAO 45 degree before and after each set of ablations. After ablation, a 15-minute waiting period will be mandated. The CTI block will be rechecked with 3D mapping system and multipolar catheter. If there is persistent CTI conduction, ablation will be repeated until CTI block is achieved. This will be followed by another 15 minutes of waiting period before rechecking the block across CTI, and so on. TNG will be prepared. It will be given via intracoronary route in 100-200mcg bolus if severe spasm is observed. If CTI block cannot be achieved with repeated PFA ablation, ablation with radiofrequency will be allowed to achieve block. Patient will come back for follow up at 3 months for a remapping procedure. During the remapping procedure, a RCA coronary angiogram will be performed to exclude late coronary damage.

Primary outcomes

  1. Rate of residual conduction

    Time frame: In 3 months follow up

    Evaluate rate of residual conduction across CTI in 3-month remapping

  2. Rate of coronary artery damage

    Time frame: In 3 months follow up

    Evaluate rate of coronary artery damage in 3-month repeat coronary angiogram

  3. Rate of acute severe coronary spasm

    Time frame: In 3 months follow up

    Evaluate rate of acute severe coronary spasm induced by PFA (>70% diameter reduction or ST change)

Secondary outcomes

  1. Rate of clinical recurrence of atrial arrhythmia

    Time frame: In 3 months follow up

    Evaluate rate of clinical recurrence of atrial arrhythmia at 3 months

  2. Number of PFA applications

    Time frame: In ablation procedure

    Evaluate number of PFA applications required to achieve CTI block

  3. Rate of successful acute conduction block by PFA alone

    Time frame: In ablation procedure

    Evaluate rate of successful acute conduction block by PFA alone

  4. Rate of successful acute conduction block in all patients (with PFA or PFA + RFA)

    Time frame: In ablation procedure

    Evaluate rate of successful acute conduction block in all patients (with PFA or PFA + RFA)

  5. Number of mapping points in right atrium in electroanatomic system

    Time frame: In mapping procedure

    Evaluate number of mapping points in right atrium in electroanatomic system

Study contacts

Contact information is provided by the study sponsor or research team.

Tsz Kin Mark Tam

CONTACT

[email protected]

852 35051750

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.