Efficacy Comparison of High and Very High Power Short Duration Pulmonary Vein Isolation

NCT05459831 | Completed DMC

• 1 other identifier: BWI- IIS-653
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To evaluate the long-term durability of PVI performed with 90W and 50W (QDot catheter). Primary hypothesis: Pulmonary vein isolation performed with 90W (QMODE+) and inter-tag distance \<5 mm is non-inferior to pulmonary vein isolation performed with 50W guided by ablation index (QMODE) and inter-tag distance \<5 mm. Study Design: 40 patients will be randomized in a 1:1 ratio to 50W and 90W PVI. Study procedures: Initial PVI will be performed via femoral access and double transseptal puncture guided by fluoroscopy and pressure monitoring. If necessary intracardiac echocardiography (ICE) will be used for the transseptal puncture. A fast anatomical left atrial map will be created with a multipolar mapping catheter; then, point-by-point PVI will be performed with QDot catheter with 50W or 90W according to randomization. Three months after the initial procedure, patients will undergo a repeated high density left atrial mapping with PentaRay or OctaRay catheter to evaluate the durability of the PVI. Exact gap numbers and locations will be registered. If necessary, reablation of the pulmonary veins (rePVI) will be performed. Inclusion criteria: Symptomatic paroxysmal/persistent AF, \>18 years, willingness to sign informed consent form. Exclusion criteria: Long-standing persistent AF, active malignancy, contraindication for anticoagulant therapy, life expectancy \<1 year, valvular AF, hyperthyroidism. Endpoints: At repeat procedure, a high density left atrial map will be created with PentaRay or if available OctaRay catheter to evaluate the durability of the PVI. Primary endpoint will be pulmonary vein reconnection.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; catheter ablation; high-power, short-duration; pulmonary vein isolation; durability

Outcome Measures

Primary Outcomes (1)

• Pulmonary vein reconnection

  Presence or absence of pulmonary vein reconnection at 3 month remapping procedure

  3 month

Secondary Outcomes (8)

• Procedure time

  Immediately after the procedure

• Fluoroscopy time

  Immediately after the procedure

• Fluoroscopy dose

  Immediately after the procedure

• Major complication

  3 month

• First pass isolation

  Immediately after the procedure

Study Arms (2)

Pulmonary vein isolation with 50W energy setting

ACTIVE COMPARATOR

In this group of subjects, the initial pulmonary vein isolation procedure will be performed using 50W radiofrequency energy. This power setting will be used for all the ablation points.

Device: QDot Micro Catheter

Pulmonary vein isolation with 90W energy setting

ACTIVE COMPARATOR

In this group of subjects, the initial pulmonary vein isolation procedure will be performed using 90W radiofrequency energy. This power setting will be used for all the ablation points.

Device: QDot Micro Catheter

Interventions

QDot Micro Catheter DEVICE

Atrial fibrillation radiofrequency ablation with 90W or 50W energy setting.

Pulmonary vein isolation with 50W energy setting; Pulmonary vein isolation with 90W energy setting

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic paroxysmal/persistent AF
• Age \>18 years
• Willingness to sign informed consent form.

You may not qualify if:

• Contraindication to ablation
• Contraindication of long-term anticoagulation
• Long-standing persistent AF
• History of PVI
• History of cardiac surgery
• Pregnancy
• Active malignancy
• Life expectancy \<1 year
• Valvular AF
• Reversible cause of AF (e.g. hyperthyroidism).

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University

Budapest, 1122, Hungary

Location

Related Publications (1)

• Szegedi N, Sallo Z, Nagy VK, Osztheimer I, Hizoh I, Lakatos B, Boussoussou M, Orban G, Boga M, Ferencz AB, Komlosi F, Toth P, Perge P, Kovacs A, Merkely B, Geller L. Long-Term Durability of High- and Very High-Power Short-Duration PVI by Invasive Remapping: The HPSD Remap Study. Circ Arrhythm Electrophysiol. 2024 Feb;17(2):e012402. doi: 10.1161/CIRCEP.123.012402. Epub 2024 Jan 29.

  PMID: 38284286 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• László Gellér, Ph.D., DSc

  Semmelweis University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 15, 2022
• Study Start: February 15, 2022
• Primary Completion: December 1, 2022
• Study Completion: October 1, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

HU (1)