NCT05459831: HPSD-Remap

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

Completed NA Last updated 15 November 2023

What this trial tests

NA trial testing QDot Micro Catheter in Atrial Fibrillation in 46 participants. Completed in 1 October 2023.

Timeline

15 February 2022

Primary endpoint
1 December 2022

1 October 2023

Quick facts

Lead sponsor	Semmelweis University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	46
Start date	15 February 2022
Primary completion	1 December 2022
Estimated completion	1 October 2023
Sites	1 location across Hungary

Drugs / interventions tested

• QDot Micro Catheter

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Semmelweis University

Who can join

Adults 18 to 100, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Long-Term Durability of High- and Very High-Power Short-Duration PVI by Invasive Remapping: The HPSD Remap Study.
   Szegedi N, Salló Z, Nagy VK, Osztheimer I, et al · · 2024 · cited 18× · PMID 38284286 · DOI 10.1161/circep.123.012402
2. Ablation Parameters Predicting Pulmonary Vein Reconnection after Very High-Power Short-Duration Pulmonary Vein Isolation.
   Boga M, Orbán G, Salló Z, Nagy KV, et al · · 2024 · PMID 39195138 · DOI 10.3390/jcdd11080230