Long-term outcomeS of cavotrIcuspid isthMus-dePendent fLuttEr Ablation: Single vs Double Catheter Procedure

NACompletedINTERVENTIONAL
Enrollment

253

Participants

Timeline

Start Date

July 16, 2020

Primary Completion Date

September 30, 2022

Study Completion Date

November 30, 2022

Conditions
Atrial Flutter
Interventions
PROCEDURE

Single catheter approach

Single venous femoral access will be obtained and the ablation will be performed similar to Group A. After the ablation line is over, we will confirm CTI block using the PRI. During atrial pacing (10 V, 1.5 ms) at a stable cycle length (range 500-700ms) from the tip of the ablation catheter with a sweep speed of 300mm/s, the ablation catheter will be placed first at 5 o'clock (medial to CTI line), then at 7 o'clock (lateral to CTI line), and finally at 9 o'clock position, and the corresponding PRIs will be measured for each pacing site. CTI block is assumed when: (i) the PRI at 7 o'clock is \>80ms longer than that at pacing sites of 5, and (ii) the PRI at 9 o'clock is shorter than the PRI at 7 o'clock.

PROCEDURE

Traditional approach

Double venous femoral access will be obtained. A duodecapolar catheter will be positioned in the right atrium around the tricuspid valve annulus (TVA) to record activation sequence around the tricuspid annulus. An ablation catheter will be positioned using fluoroscopic guidance in the central CTI, 6 o'clock in a left anterior oblique view. The distal ablation electrode position will then be adjusted toward or away from the TVA, based on the ratio of atrial and ventricular electrogram amplitudes with an optimal ratio of 1:2 or 1:4 at the TVA. After the ablation catheter is positioned, it will be very slowly withdrawn during ablation toward the inferior vena cava while radiofrequency energy is applied continuously. CTI block will be evaluated after ablation by determining the right atrial activation sequence during pacing from the low lateral right atrium and coronary sinus ostium.

Trial Locations (3)

08022

Centro Medico Teknon, Barcelona

Unknown

Puerta del Mar University Hospital, Cadiz

Virgen del Rocio University Hospital, Seville

All Listed Sponsors
lead

Centro Medico Teknon

OTHER

NCT04472936 - Long-term outcomeS of cavotrIcuspid isthMus-dePendent fLuttEr Ablation: Single vs Double Catheter Procedure | Biotech Hunter | Biotech Hunter