Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Patients With Atrial Fibrillation and hypErtension

NCT ID: NCT05024630

Last Updated: 2021-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2023-06-30

Brief Summary

The DUAL-ICE study is a single-center, prospective, randomized controlled study. The main purpose is to verify that renal artery cryoablation combined with pulmonary vein cryoablation can reduce the recurrence of atrial fibrillation in hypertensive patients with paroxysmal atrial fibrillation and substandard hypertension, and to further verify the clinical significance of one-stop cardio-renal combined cryoablation therapy for hypertension control.

Detailed Description

Hypertension is a major risk factor for the high morbidity and mortality of cardiovascular diseases in the world. As a common arrhythmia, the autonomic nervous system plays an important role in the occurrence and maintenance of atrial fibrillation [1,2]. Enhancement of central sympathetic nervous system activity and stimulation of the efferent sympathetic nerve of the heart can promote the occurrence and development of atrial fibrillation [3]. Hypertension is an important risk factor for the occurrence of atrial fibrillation, and the incidence of complications such as heart failure, coronary heart disease and left ventricular hypertrophy is increased in patients with atrial fibrillation with poor blood pressure control [4-6]. Therefore, hypertension management in patients with atrial fibrillation is particularly important.

However, a 2014 study of SYMPLICITY HTN-3 with a sample size of 535 people showed that RDN could not significantly reduce blood pressure [10], which put the study of RDN into a dilemma. Since then, researchers have optimized the study design, and some more detailed results have suggested a significant antihypertensive effect of RDN [11-13].

At present, there are few reports on the cryo-ablation of renal sympathetic nerve in the RDN studies, only the case of cryo-ablation of renal artery by Dr.Prochnau et al in Germany in 2014, which is still a technical blank in China [14]. At present, catheter ablation has been widely recognized in the treatment of paroxysmal atrial fibrillation. In terms of patient comfort and efficacy, cryo-ablation promoted in recent years shows greater advantages than radiofrequency ablation, which has the characteristics of less damage to surrounding tissues and faster recovery of vascular endothelial function. Therefore, the application of cryoablation in the field of RDN may be similar to the effect of pulmonary vein ablation. The purpose of our study was to investigate whether renal artery cryoablation combined with pulmonary vein cryoablation reduces the recurrence rate of atrial fibrillation compared with pulmonary vein cryoablation alone.

Conditions

Paroxysmal Atrial Fibrillation; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RDN+PVI group

The experimental group received renal artery cryoablation and pulmonary vein cryoablation. Pulmonary vein cryoablation was first followed by renal artery cryoablation.

Group Type: EXPERIMENTAL

Renal artery cryoablation

Intervention Type: PROCEDURE

Renal denervation were achieved by cryoablation of renal artery with cryoballoon.

Pulmonary vein cryoablation

Intervention Type: PROCEDURE

Pulmonary vein isolation was achieved by cryoablation of pulmonary veins with cryoballoon.

PVI only group

The control group received pulmonary vein cryoablation alone. To ensure single blindness, the control group received femoral artery puncture and renal arteriography after cryoablation.

Group Type: SHAM_COMPARATOR

Pulmonary vein cryoablation

Intervention Type: PROCEDURE

Pulmonary vein isolation was achieved by cryoablation of pulmonary veins with cryoballoon.

Renal arteriography

Intervention Type: PROCEDURE

Renal artery was examined by renal arteriography

Interventions

Renal artery cryoablation

Renal denervation were achieved by cryoablation of renal artery with cryoballoon.

Intervention Type: PROCEDURE

Pulmonary vein cryoablation

Pulmonary vein isolation was achieved by cryoablation of pulmonary veins with cryoballoon.

Intervention Type: PROCEDURE

Renal arteriography

Renal artery was examined by renal arteriography

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years old, and <75 years old, gender is not limited;

2. Hypertensive patients with symptomatic paroxysmal atrial fibrillation to be treated by catheter ablation with substandard blood pressure. SBP ≥ 150 mmHg or DBP ≥ 90 mmHg in patients taking at least one antihypertensive drug;

3. Agree to participate and sign the informed consent.

Exclusion Criteria

1. Cannot accept catheter ablation (such as thrombus in left atrium/left atrial appendage, recent myocardial infarction, stroke, etc.);

2. Patients with obvious bleeding tendency or unable to accept postoperative anticoagulation;

3. The anteroposterior diameter of left atrium indicated by echocardiography was ≥50mm;

4. A history of left atrial surgery or left atrial interventional therapy (including cryo-ablation, radiofrequency ablation, left atrial appendage occlusion, etc.);

5. NYHA grade IV congestive heart failure or LVEF <30%;

6. patients with valvular atrial fibrillation and secondary atrial fibrillation (such as uncontrolled hyperthyroidism, acute alcoholism, atrial fibrillation after cardiac surgery, etc.);

7. Patients with typical atrial fluttering or other supraventricular tachycardia (duration greater than 30s) confirmed by preoperative electrocardiogram or dynamic electrocardiogram;

8. Severe organic heart disease, including moderate to severe mitral insufficiency or stenosis, previous myocardial infarction, hypertrophic cardiomyopathy, etc.;

9. Patients with secondary hypertension;

10. Uncontrollable pulmonary hypertension;

11. Patients with glomerular filtration rate (EGFR) < 45ml/min/1.73m2 or patients with chronic kidney disease, nephrotic syndrome, polycystic kidney disease and other renal diseases were estimated according to MDRD calculation method;

1. inability to access the renal vascular system;

2. Diameter of renal aorta less than 4 mm or length less than 20 mm;

3. Hemodynamic or anatomical renal artery abnormalities or stenosis;

4. A history of previous renal artery interventions, including balloon angioplasty or stenting;

5. There are multiple unilateral renal aortas leading to the kidney;

13. Participated in other clinical studies and not yet enrolled in the group;

14. Women who are pregnant, lactating or preparing to become pregnant;

15. Life expectancy less than 1 year;

16. Other conditions that are not suitable for inclusion in this study as assessed by the researcher, such as mental disorders or psychological disorders;

17. A history of acute coronary events or percutaneous coronary stent intervention, a history of stroke or transient ischemic attack, and extensive atherosclerosis with intravascular thrombosis within the last 6 months;

18. Patients with ICD implantation history or CRT treatment history.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ya-Wei Xu

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Yi Zhang

Role: CONTACT

yizshcn@gmail.com

18917686332

Yawei Xu

Role: CONTACT

479267058@qq.com

18917684008

References

Grassi G. Assessment of sympathetic cardiovascular drive in human hypertension: achievements and perspectives. Hypertension. 2009 Oct;54(4):690-7. doi: 10.1161/HYPERTENSIONAHA.108.119883. Epub 2009 Aug 31.

Reference Type: BACKGROUND

PMID: 19720958 (View on PubMed)

Schlaich MP, Sobotka PA, Krum H, Whitbourn R, Walton A, Esler MD. Renal denervation as a therapeutic approach for hypertension: novel implications for an old concept. Hypertension. 2009 Dec;54(6):1195-201. doi: 10.1161/HYPERTENSIONAHA.109.138610. Epub 2009 Oct 12. No abstract available.

Reference Type: BACKGROUND

PMID: 19822798 (View on PubMed)

Arora R, Ng J, Ulphani J, Mylonas I, Subacius H, Shade G, Gordon D, Morris A, He X, Lu Y, Belin R, Goldberger JJ, Kadish AH. Unique autonomic profile of the pulmonary veins and posterior left atrium. J Am Coll Cardiol. 2007 Mar 27;49(12):1340-8. doi: 10.1016/j.jacc.2006.10.075. Epub 2007 Mar 12.

Reference Type: BACKGROUND

PMID: 17394967 (View on PubMed)

Krahn AD, Manfreda J, Tate RB, Mathewson FA, Cuddy TE. The natural history of atrial fibrillation: incidence, risk factors, and prognosis in the Manitoba Follow-Up Study. Am J Med. 1995 May;98(5):476-84. doi: 10.1016/S0002-9343(99)80348-9.

Reference Type: BACKGROUND

PMID: 7733127 (View on PubMed)

Benjamin EJ, Levy D, Vaziri SM, D'Agostino RB, Belanger AJ, Wolf PA. Independent risk factors for atrial fibrillation in a population-based cohort. The Framingham Heart Study. JAMA. 1994 Mar 16;271(11):840-4.

Reference Type: BACKGROUND

PMID: 8114238 (View on PubMed)

Joshi S, Choi AD, Kamath GS, Raiszadeh F, Marrero D, Badheka A, Mittal S, Steinberg JS. Prevalence, predictors, and prognosis of atrial fibrillation early after pulmonary vein isolation: findings from 3 months of continuous automatic ECG loop recordings. J Cardiovasc Electrophysiol. 2009 Oct;20(10):1089-94. doi: 10.1111/j.1540-8167.2009.01506.x. Epub 2009 Jun 22.

Reference Type: BACKGROUND

PMID: 19549038 (View on PubMed)

Schlaich MP, Sobotka PA, Krum H, Lambert E, Esler MD. Renal sympathetic-nerve ablation for uncontrolled hypertension. N Engl J Med. 2009 Aug 27;361(9):932-4. doi: 10.1056/NEJMc0904179. No abstract available.

Reference Type: BACKGROUND

PMID: 19710497 (View on PubMed)

Krum H, Schlaich MP, Sobotka PA, Bohm M, Mahfoud F, Rocha-Singh K, Katholi R, Esler MD. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet. 2014 Feb 15;383(9917):622-9. doi: 10.1016/S0140-6736(13)62192-3. Epub 2013 Nov 7.

Reference Type: BACKGROUND

PMID: 24210779 (View on PubMed)

Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010 Dec 4;376(9756):1903-9. doi: 10.1016/S0140-6736(10)62039-9. Epub 2010 Nov 17.

Reference Type: BACKGROUND

PMID: 21093036 (View on PubMed)

Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.

Reference Type: BACKGROUND

PMID: 24678939 (View on PubMed)

Bohm M, Kario K, Kandzari DE, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Konstantinidis D, Choi JW, East C, Lee DP, Ma A, Ewen S, Cohen DL, Wilensky R, Devireddy CM, Lea J, Schmid A, Weil J, Agdirlioglu T, Reedus D, Jefferson BK, Reyes D, D'Souza R, Sharp ASP, Sharif F, Fahy M, DeBruin V, Cohen SA, Brar S, Townsend RR; SPYRAL HTN-OFF MED Pivotal Investigators. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet. 2020 May 2;395(10234):1444-1451. doi: 10.1016/S0140-6736(20)30554-7. Epub 2020 Mar 29.

Reference Type: BACKGROUND

PMID: 32234534 (View on PubMed)

Kandzari DE, Bohm M, Mahfoud F, Townsend RR, Weber MA, Pocock S, Tsioufis K, Tousoulis D, Choi JW, East C, Brar S, Cohen SA, Fahy M, Pilcher G, Kario K; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355. doi: 10.1016/S0140-6736(18)30951-6. Epub 2018 May 23.

Reference Type: BACKGROUND

PMID: 29803589 (View on PubMed)

Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Davies J, Basile J, Kirtane AJ, Wang Y, Lobo MD, Saxena M, Feyz L, Rader F, Lurz P, Sayer J, Sapoval M, Levy T, Sanghvi K, Abraham J, Sharp ASP, Fisher NDL, Bloch MJ, Reeve-Stoffer H, Coleman L, Mullin C, Mauri L; RADIANCE-HTN Investigators. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018 Jun 9;391(10137):2335-2345. doi: 10.1016/S0140-6736(18)31082-1. Epub 2018 May 23.

Reference Type: BACKGROUND

PMID: 29803590 (View on PubMed)

Prochnau D, Heymel S, Otto S, Figulla HR, Surber R. Renal denervation with cryoenergy as second-line option is effective in the treatment of resistant hypertension in non-responders to radiofrequency ablation. EuroIntervention. 2014 Sep;10(5):640-5. doi: 10.4244/EIJV10I5A110.

Reference Type: BACKGROUND

PMID: 25256203 (View on PubMed)

Andrade JG, Wells GA, Deyell MW, Bennett M, Essebag V, Champagne J, Roux JF, Yung D, Skanes A, Khaykin Y, Morillo C, Jolly U, Novak P, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Lauck S, Macle L, Verma A; EARLY-AF Investigators. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):305-315. doi: 10.1056/NEJMoa2029980. Epub 2020 Nov 16.

Reference Type: BACKGROUND

PMID: 33197159 (View on PubMed)

Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.

Reference Type: BACKGROUND

PMID: 27042964 (View on PubMed)

Wazni OM, Dandamudi G, Sood N, Hoyt R, Tyler J, Durrani S, Niebauer M, Makati K, Halperin B, Gauri A, Morales G, Shao M, Cerkvenik J, Kaplon RE, Nissen SE; STOP AF First Trial Investigators. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):316-324. doi: 10.1056/NEJMoa2029554. Epub 2020 Nov 16.

Reference Type: BACKGROUND

PMID: 33197158 (View on PubMed)

Pokushalov E, Romanov A, Corbucci G, Artyomenko S, Baranova V, Turov A, Shirokova N, Karaskov A, Mittal S, Steinberg JS. A randomized comparison of pulmonary vein isolation with versus without concomitant renal artery denervation in patients with refractory symptomatic atrial fibrillation and resistant hypertension. J Am Coll Cardiol. 2012 Sep 25;60(13):1163-70. doi: 10.1016/j.jacc.2012.05.036. Epub 2012 Sep 5.

Reference Type: BACKGROUND

PMID: 22958958 (View on PubMed)

Steinberg JS, Shabanov V, Ponomarev D, Losik D, Ivanickiy E, Kropotkin E, Polyakov K, Ptaszynski P, Keweloh B, Yao CJ, Pokushalov EA, Romanov AB. Effect of Renal Denervation and Catheter Ablation vs Catheter Ablation Alone on Atrial Fibrillation Recurrence Among Patients With Paroxysmal Atrial Fibrillation and Hypertension: The ERADICATE-AF Randomized Clinical Trial. JAMA. 2020 Jan 21;323(3):248-255. doi: 10.1001/jama.2019.21187.

Reference Type: BACKGROUND

PMID: 31961420 (View on PubMed)

Other Identifiers

DUAL-ICE

Identifier Type: -

Identifier Source: org_study_id