SAVER: Spontaneous Atrio Ventricular Conduction Preservation

Sponsor

LivaNova (Industry)

Overall Status

Completed

CT.gov ID

NCT00655213

Collaborator

(none)

622

Enrollment

Locations

Arms

Duration (Months)

9.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In case of sinus node dysfunction, it is often necessary to choose the safer option provided by a DDD pacemaker even though the most appropriate mode of pacing is AAI mode.

In addition to saving energy, the latter mode allows spontaneous ventricular activation, the haemodynamic consequences of which are, in most cases, better than those obtained with dual chamber pacing.

Recent studies as the MOST study suggest also that ventricular desynchronization imposed by right ventricular apical pacing even when AV synchrony is preserved increases the risk of atrial fibrillation in patients with SND. Similar results were already given by anterior studies (PIPAF) which, taking into account the percentage of ventricular pacing, suggested that AF prevention algorithm in combination with a preserved native conduction are efficient in reducing AF burden.

However, current practice is to implant a dual chamber pacemaker to prevent the risk of atrioventricular block (AVB) even if DDDR pacing with a fixed long AV delay was found inefficient in reducing ventricular pacing and was associated with a high risk of arrhythmias.

The Symphony 2550 cardiac pacemaker offers pacing modes that automatically switch from AAI(R) mode to DDD(R) or DDI(R) in event of severe atrioventricular conduction disorder, irrespective of whether or not these are accompanied by an atrial arrhythmia, returning spontaneously to AAI(R) mode as soon as the spontaneous AV conduction has resumed. These 2 particular modes are called the AAI SafeR and DDD/AMC (R) mode.

The main differences between both modes are that (i) AAI SafeR does not trigger any AV Delay after a sensed or paced atrial event which allows long PR intervals or even limited ventricular pauses with no switch to DDD(R), while (ii) DDD/AMC (R) is able to optimize AV Delay after switching to DDD(R) according to measured spontaneous conduction times and to provide an acceleration in case of vaso-vagal syndrome. This pacing mode has previously been assessed in clinical studies.

This study intends to demonstrate that the automatic modes switching significantly reduce the percentage of ventricular pacing in patients implanted with a spontaneous AV conduction and reduce the occurrence of atrial arrhythmias, on a mid-term follow-up period, in comparison to standard DDD pacing with long AVDelay.

Condition or Disease	Intervention/Treatment	Phase
Sinus Node Dysfunction Bradycardia-Tachycardia Syndrome Paroxysmal Atrioventricular Block	Device: Symphony D 2450 Device: Symphony DR 2550	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

622 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Spontaneous Atrio Ventricular Conduction Preservation

Study Start Date :

Nov 1, 2003

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 AAISafeR mode programming	Device: Symphony D 2450 Device: Symphony DR 2550
Active Comparator: 2 DDD with long AV Delay programming	Device: Symphony D 2450 Device: Symphony DR 2550
Active Comparator: 3 DDDAMC mode programming	Device: Symphony D 2450 Device: Symphony DR 2550
Other: 4 AAISafer mode programming in non randomized patients	Device: Symphony D 2450 Device: Symphony DR 2550

Outcome Measures

Primary Outcome Measures

mean percentage of ventricular pacing between the randomized branches on a two-months period (M3 visit) [2 months]
mean percentage of ventricular pacing between the studied groups during the whole study (up to 1 year). [12 months]

Secondary Outcome Measures

percentage of ventricular pacing two month after randomization versus the percentage reported at the end of the first month follow-up in AAIsafeR mode. [12 months]
AF burden relatively to the branch of the protocol [12 months]
evolution of conduction disturbances by documentings nature, number and duration of ario-ventricular blocks. [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient has been primo-implanted with a Symphony™ 2550 or 2450 devices for less than 3 months
Patient with a normal spontaneous AV conduction at rest (PR < 250 ms)
Patient implanted for Sinus Node Dysfunction, Braycardia-Tachycardia Syndrome, carotid sinus syndrome/ vaso vagal syndrome or paroxistic AV Block
Patient implanted with a bipolar right-atrial lead and ventricular lead available in the local market
Patient has signed a consent form after having received the appropriate information

Exclusion Criteria:

Permanent 1st, 2nd or 3rd AV block
Patient having a medical status complying with one of the following cases
patient suffering from sustained ventricular arrhythmias
patient having sustained a myocardial infarction within the last month
patient having undergone cardiac surgery within the last month
patient suffering from severe aortic stenosis
patient suffering from unstable angina pectoris
patient presents with permanent atrial arrhythmias
Patient is not able to understand the study objectives and protocol or refuses to co-operate
Patient is not available for scheduled follow-up
Patient has a life expectancy less than one year
Patient is included into another clinical study
Patient is minor or a pregnant woman

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Onze lieve Vrouw ziekenhuis	Aalst	Belgium
2	Clinique Louis Caty	Baudour	Belgium
3	Hôpital universitaire Brugmann	Bruxelles	Belgium
4	Europa ziekenhuis	Campus st. Elisabeth Uccle	Belgium
5	Heiling Hart van Jezus	Moen	Belgium
6	Hôpital Vésale (univ.)	Montigny Le Tilleul	Belgium
7	CHU - Tivoli	Tivoli	Belgium
8	Centre Hospitalier	Aix-en-Provence	France
9	CH Albi	Albi	France
10	CHU d'Angers	Angers	France
11	CHU Jean Minjoz	Besancon	France
12	CH de CASTRES	Castres-mazamet	France
13	Hospice St-Jacques-Hôspital G.Montpied	Clermont-Ferrand	France
14	CHU - Hopital Michallon	Grenoble	France	38043
15	CHRU de Lille - Hôpital Cardiologique	Lille	France
16	CHU de Limoges	Limoges	France
17	CH Montpellier	Montpellier	France
18	CH Emile Muller	Mulhouse	France
19	CHU de Nantes	Nantes	France
20	Nouvelles Cliniques Nantaises	Nantes	France
21	CHU de Nice	Nice	France
22	Clinique Bizet	Paris cedex 16	France	75116
23	CHU Pontchaillou	Rennes	France
24	CHU Hopital C. Nicolle	Rouen	France	76035
25	InParys Cardiology	St Cloud	France
26	CHU de Nancy	Vandoeuvre les Nancy	France	54511
27	Marien Hospital	Bonn	Germany
28	Universitätskliniken Bonn	Bonn	Germany
29	St.Josef-Stift Bremen	Bremen	Germany
30	St. Salvator Krankenhaus Halberstadt	Halberstadt	Germany
31	Holzminden Praxis Bub	Holzminden	Germany
32	Hürth Sana	Hürth	Germany
33	Herzzentrum Kassel	Kassel	Germany
34	KH Holweide	Koln	Germany
35	Klinikum Lüdenscheid	Luedenscheid	Germany
36	Universitätsklinikum Schleswig-Holstein	Lübeck	Germany
37	Städt. Kh. Lüneburg	Lüneburg	Germany
38	Univ. Mainz	Mainz	Germany
39	Univ. Marburg	Marburg	Germany
40	Klinkum Memmingen	Memmingen	Germany
41	Augustinum	Munchen	Germany
42	Klinikum Bogenhausen	Munchen	Germany
43	Rot-Kreuz Krankenhaus	Munchen	Germany
44	Praxis Bitar	Peine	Germany
45	Uni Regensburg	Regensburg	Germany
46	Prof. Frey Praxis Starnberg	Starnberg	Germany
47	Uni Ulm	Ulm	Germany
48	Waren-Müritzklinikum	Waren	Germany
49	Klinikum Wolgast	Wolgast	Germany
50	Ospedale Moscati	Avellino	Italy
51	Ospedale Mellini	Chiari (BS)	Italy
52	Ospedale Civile	Conegliano (TV)	Italy
53	Ospedale S. G. Battista	Foligno (PG)	Italy
54	Ospedale Umberto I	Mestre (VE)	Italy
55	Ospedale Civile	Portogruaro (VE)	Italy
56	Istituto Policlinico	San Donato	Italy
57	Ospedale Civile	Sesto S. Giovanni (MI)	Italy
58	Ospedale Civile	Trento	Italy
59	Ospedale Civili Reuniti	Venezia	Italy
60	Ospedale Civile	Voghera	Italy
61	Queen Elizabeth Hospital	Birmingham	United Kingdom
62	Bristol Royal Infirmary	Bristol	United Kingdom
63	Queens Hospital	Burton on Trent	United Kingdom
64	Castle Hill Hospital	Hull	United Kingdom
65	Leeds General Infirmary	Leeds	United Kingdom
66	Barts and The London NHS Trust	London	United Kingdom
67	St Thomas' Hospital,	London	United Kingdom