Pulmonary Vein Isolation Guided by Ablation Index (Ablation Index Registry Study)

NCT03277976 | Completed

• 1 other identifier: AIR Study
• Study Type: observational
• Target: 490
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multi-center, research study designed to evaluate the acute achievement of pulmonary vein (PV) isolation with ThermoCool SmartTouch (ST) and ThermoCool SmartTouch SF (STSF) catheter using the Ablation Index Module.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation;; catheter ablation;; pulmonary vein isolation; ablation index

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to evaluate which ablation strategy increase the rate of WACA PV isolation, validated by mean of LASSO catheter, after first encirclement, from 70% to 80%.

  From the end of the WACA PV isolation up to 5 min after

Secondary Outcomes (4)

• Incidence of early PV reconnection 30 minutes after acute PV isolation.

  Up to 30 min after the effective pulmonary vein isolation

• Difference in procedural and fluoroscopy time between the two groups

  From the beginning of the index procedure to the end of index procedure

• Incidence of AF recurrence during the blanking period

  Up to 3 months after the ablation procedure

• Incidence of treatment-emergent adverse events.

  Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, from the index procedure to one-year follow-up

Study Arms (4)

ThermoCool SmartTouch 1

In this cohort are included patients who will undergo atrial fibrillation ablation using the ThermoCool SmartTouch Catheter and Ablation Index range: 380 for the posterior wall and 500 for the anterior wall

Device: PVI using ThermoCool® SmartTouch® Catheter

ThermoCool SmartTouch 2

In this cohort are included patients who will undergo atrial fibrillation ablation using the ThermoCool SmartTouch Catheter and Ablation Index range: 330 for the posterior wall and 450 for the anterior wall

Device: PVI using ThermoCool® SmartTouch® Catheter

ThermoCool SmartTouch SF 1

In this cohort are included patients who will undergo atrial fibrillation ablation using the ThermoCool SmartTouch SF Catheter and Ablation Index range: 330 for the posterior wall and 450 for the anterior wall

Device: PVI using ThermoCool® SmartTouch SF® Catheter

ThermoCool SmartTouch SF 2

In this cohort are included patients who will undergo atrial fibrillation ablation using the ThermoCool SmartTouch SF Catheter and Ablation Index range: 380 for the posterior wall and 500 for the anterior wall

Device: PVI using ThermoCool® SmartTouch SF® Catheter

Interventions

PVI using ThermoCool® SmartTouch® Catheter DEVICE

PVI using RFA, using ThermoCool® SmartTouch® Catheter (Biosense Webster Inc., CA, US), guided by Ablation Index

ThermoCool SmartTouch 1; ThermoCool SmartTouch 2

PVI using ThermoCool® SmartTouch SF® Catheter DEVICE

PVI using RFA, using ThermoCool® SmartTouch SF® Catheter (Biosense Webster Inc., CA, US), guided by Ablation Index

ThermoCool SmartTouch SF 1; ThermoCool SmartTouch SF 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with paroxysmal and persistent atrial fibrillation (AF) will undergo catheter ablation using commercially approved devices (mapping system and catheters).

You may qualify if:

• Subject is indicated for catheter ablation for paroxysmal AF;
• Subject is \> 18 years old;
• Subject is \< 80 years old ;
• Subject is on adequate anticoagulation therapy

You may not qualify if:

• Patients who had already undergo an AF ablation procedure;
• Patients with left ventricular ejection fraction \< 35%
• Women of childbearing potential who are or might be pregnant
• Hematological contraindications to ionizing radiation exposure
• Presence of complex congenital heart disease, and cardiac surgery within 1 month from enrollment

Sponsors & Collaborators

• Clinica Mediterranea: lead

Study Sites (1)

Clinica Mediterranea

Naples, Italy

Location

Related Publications (4)

• El Haddad M, Taghji P, Phlips T, Wolf M, Demolder A, Choudhury R, Knecht S, Vandekerckhove Y, Tavernier R, Nakagawa H, Duytschaever M. Determinants of Acute and Late Pulmonary Vein Reconnection in Contact Force-Guided Pulmonary Vein Isolation: Identifying the Weakest Link in the Ablation Chain. Circ Arrhythm Electrophysiol. 2017 Apr;10(4):e004867. doi: 10.1161/CIRCEP.116.004867.

  PMID: 28381417 BACKGROUND

• Das M, Loveday JJ, Wynn GJ, Gomes S, Saeed Y, Bonnett LJ, Waktare JEP, Todd DM, Hall MCS, Snowdon RL, Modi S, Gupta D. Ablation index, a novel marker of ablation lesion quality: prediction of pulmonary vein reconnection at repeat electrophysiology study and regional differences in target values. Europace. 2017 May 1;19(5):775-783. doi: 10.1093/europace/euw105.

  PMID: 27247002 BACKGROUND

• Das M, Wynn GJ, Morgan M, Lodge B, Waktare JE, Todd DM, Hall MC, Snowdon RL, Modi S, Gupta D. Recurrence of atrial tachyarrhythmia during the second month of the blanking period is associated with more extensive pulmonary vein reconnection at repeat electrophysiology study. Circ Arrhythm Electrophysiol. 2015 Aug;8(4):846-52. doi: 10.1161/CIRCEP.115.003095. Epub 2015 Jun 24.

  PMID: 26108982 RESULT

• Stabile G, Di Donna P, Schillaci V, Di Monaco A, Iuliano A, Caponi D, Urraro F, Solimene F, Grimaldi M, Scaglione M. Safety and efficacy of pulmonary vein isolation using a surround flow catheter with contact force measurement capabilities: A multicenter registry. J Cardiovasc Electrophysiol. 2017 Jul;28(7):762-767. doi: 10.1111/jce.13227. Epub 2017 Jun 21.

  PMID: 28422368 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: September 11, 2017
• Study Start: November 29, 2017
• Primary Completion: September 28, 2018
• Study Completion: November 28, 2019
• Last Updated: March 5, 2024

Record last verified: 2018-08

Locations

IT (1)