FREEZE Cohort Study

Conditions

Arrhythmia

Keywords

Cardiac arrhythmia, Catheter ablation, Cohort Study, cryoballoon, radiofrequency

Brief summary

Safety and efficacy in radiofrequency (RF) or cryoballoon atrial fibrillation (AF) ablation will be investigated in a cohort study design in experienced electrophysiologic (EP) centers analyzing propensity-matched cohorts.

Detailed description

Prior to participation in the cohort-study each EP center had to perform a minimum of 50 RF or 50 cryoballoon approaches. To insure the consecutiveness of recruitment, participating centers have to announce the intention to ablate the patient prior to the procedure to the coordinating center in Ludwigshafen. After inclusion of 500 patients with well accepted criteria for AF ablation undergoing cryoballoon pulmonary vein isolation (PVI) in experienced german EP centers inclusion of patients will be extended to european centers. A total of 4.000 patients will be included in the cohort-study, 2.000 in both the cryoballoon and the RF arm.

Pongratz J, Kuck KH, Metzner A, Hink U, Garcia Alberola A, Borchard R, Nölker G, Kuniss M, Tilz RR, Schrickel JW, Thornton A, Thomas D, Katus HA, Zahn R, Spitzer S, Souza JJ, Brachmann J, Tebbenjohanns J, Wu LQ, Obel WP, Groschup G, Stellbrink C, Chun KRJ, Gerds-Li JH, Stanley A, Gopal RR, Lickfett L, Lubinski A, Schumacher B, Steinwender C, Franke HA, Ouarrak T, Dorwarth U, Senges J, Hoffmann E, Straube F, FREEZE Cohort Study Investigators.

2025-06-191 citations

10.1016/j.ijcha.2025.101721

Impact of intracardiac echocardiography usage on the safety of cryoballoon atrial fibrillation ablation: Subanalysis of the prospective FREEZE cluster cohort study

Janis Pongratz, Malte Kuniss, Liqun Wu, Jürgen Tebbenjohanns, Georg Nölker et al. (11 authors)

Journal of Cardiovascular Electrophysiology2023-09-083 citations

10.1111/jce.16060

Comparison of quality-of-life following cryoballoon versus radiofrequency catheter ablation of symptomatic atrial fibrillation - a subanalysis of the FREEZE cohort study

Florian Straube, Uwe Dorwarth, J. Pongratz, L Riess, Malte Kuniss et al. (15 authors)

EP Europace2023-05-24

10.1093/europace/euad122.104

Electrophysiology lab efficiency comparison between cryoballoon and point-by-point radiofrequency ablation: a German sub-analysis of the FREEZE Cohort study.

Metzner A, Straube F, Tilz RR, Kuniss M, Noelker G, Tebbenjohanns J, Andresen D, Wieneke H, Stellbrink C, Franke J, Dorwarth U, Carion PL, Holbrook R, Hochadel M, Senges J, Hoffmann E, Kuck KH, FREEZE Cohort Study Investigators.

2023-01-098 citations

10.1186/s12872-022-03015-8

Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation

Ellen Hoffmann, Florian Straube, Karl Wegscheider, Malte Kuniss, Dietrich Andresen et al. (49 authors)

EP Europace2019-05-03123 citations

10.1093/europace/euz155

First-line catheter ablation of paroxysmal atrial fibrillation: outcome of radiofrequency vs. cryoballoon pulmonary vein isolation

Florian Straube, Uwe Dorwarth, Sonia Ammar‐Busch, Timo Peter, Georg Noelker et al. (15 authors)

EP Europace2015-10-2576 citations

10.1093/europace/euv271

Differences of two cryoballoon generations: insights from the prospective multicentre, multinational FREEZE Cohort Substudy

Florian Straube, Uwe Dorwarth, Juergen Vogt, Malte Kuniss, Karl Heinz Kuck et al. (14 authors)

EP Europace2014-07-0353 citations

10.1093/europace/euu162

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Documented paroxysmal AF (2 episodes of PAF within the last 3 months) or Persistent AF (lasting \< 1 year) * First ablation of AF * Age ≥18 years * Documented inefficacy of at least 1 AAD not including β-blockers * Written informed consent

Exclusion criteria

* Longstanding persistent AF lasting \> 1 year * Acute coronary syndrome (ACS) * Heart failure NYHA IV * Thrombocytosis, thrombocytopenia * Any condition contraindicating chronic anticoagulation * Stroke or TIA within 6 months prior to ablation * Uncontrolled hyperthyroidism * Pregnancy * Life expectancy \< 1 year

Design outcomes

Primary

Measure	Time frame
AF recurrency rate (any detected episode lasting > 30 sec) at 12 months follow up	Admission to hospital until 12 months thereafter

Secondary

Measure	Time frame
Comparison of complication rates (any complications and major complications) at 12 months follow-up	Admission to hospital until 12 months thereafter
Specific complication aspects with respect to phrenic nerve palsy and PV stenosis	Admission to Hospital until 12 months thereafter
Efficacy (AF recurrency rates), safety (complication rates), and procedural parameters in cryoballoon or RF ablation as means for assessing advantages of preprocedural CT or MRI scan performing 3 D anatomy of the left atrium and pulmonary veins	Admission to Hospital until 12 months thereafter
Persistent AF: Impact on efficacy analyzing procedural aspects in cryoballoon PVI	Admission to Hospital until 12 months thereafter
Real-time ECG-monitoring of PV-isolation during freezing: Does the microcircular mapping catheter add significant benefit to the cryoballoon procedure	Admission to Hospital until 12 months thereafter

Countries

Austria, Germany, Greece, South Africa, Spain, United States

Outcome results